Young Ki Lee, Sung Gyun Kim, Jang Won Seo, Ji Eun Oh, Jong-Woo Yoon, Ja-Ryong Koo, Hyung Jik Kim and Jung Woo Noh
|
|
- Briana O’Neal’
- 6 years ago
- Views:
Transcription
1 Nephrol Dial Transplant (2008) 23: doi: /ndt/gfn255 Advance Access publication 9 May 2008 Original Article A comparison between once-weekly and twice- or thrice-weekly subcutaneous injection of epoetin alfa: results from a randomized controlled multicentre study Young Ki Lee, Sung Gyun Kim, Jang Won Seo, Ji Eun Oh, Jong-Woo Yoon, Ja-Ryong Koo, Hyung Jik Kim and Jung Woo Noh Department of Internal Medicine, Hallym Kidney Research Institute, College of Medicine, Hallym University, Seoul, Korea Abstract Background. In patients with chronic renal failure, the ability to reduce the administration frequency of subcutaneous (SC) erythropoietin (epoetin) could provide benefits and may improve compliance. The study investigated whether once-weekly SC epoetin alfa was equivalent to twice- or thrice-weekly SC administration in maintaining anaemia correction in haemodialysis patients. Methods. Eighty-three patients were randomly assigned to either once-weekly epoetin alfa (n = 44) or their original dose twice- or thrice-weekly regimen (control, n = 39) for 12 weeks. The haemoglobin concentration was maintained within the target range of g/dl by adjusting the dose of epoetin alfa. All patients received intravenous iron supplementation, as required. Results. Stable haemoglobin levels were maintained without epoetin dose increases in the majority of patients in both groups (once-weekly group, 95.0%, control group, 91.4%). The mean haemoglobin levels at randomization at weeks 4, 8 and 12 were 10.7, 11.1, 11.3 and 11.0 g/dl, respectively, in the once-weekly group, and 10.5, 11.3, 11.5 and 11.3 g/dl, respectively, in the control group. The mean weekly dose of epoetin alfa at randomization at weeks 4, 8 and 12 was 142.8, 114.5, and IU/kg, respectively, in the once-weekly group, and 128.4, 116.0, and 96.1 IU/kg/week, respectively, in the control group. No statistically significant between-group differences were apparent for changes in haemoglobin levels or epoetin alfa dosages at week 12. Conclusions. This study demonstrates that once-weekly SC administration of epoetin alfa is as effective and safe as two or three times weekly administration in maintaining haemoglobin levels. Therefore, the once-weekly therapy using high dose of epoetin alfa is considered to be an efficient method in stable haemodialysis patients. Keywords: anaemia; erythropoietin; haemodialysis Correspondence and offprint request to: Jung Woo Noh, Department of Internal Medicine, Kangnam Sacred Heart Hospital, College of Medicine, Hallym University, 948-1, Daerim 1-dong, Youngdeungpo-Ku, Seoul, Korea. jwn8671@unitel.co.kr Introduction Insufficient production of erythropoietin (EPO; epoetin) is the primary cause of anaemia in patients with chronic renal failure, and epoetin treatment is an established treatment for renal anaemia. It is also known that it is effective for the improvement of quality of life and overall sense of wellbeing in dialysis patients [1]. For the route of epoetin administration, subcutaneous (SC) administration is more convenient than intravenous (IV) administration in patients with peritoneal dialysis or chronic kidney disease without a fistula. The SC route improved the efficiency of therapy, resulting in a reduced dosing requirement for epoetin to maintain the target haemoglobin level [2]. The dose of epoetin required to maintain haemoglobin levels equivalent to that achieved with the IV administration is lower by 33%, when the SC route is used [3]. However, many patients with haemodialysis still continue to be treated via the IV route. The primary reason is probably discomfort with subcutaneous injections. The SC administration of two or three times weekly causes pain at every injection, once-weekly therapy using high dose of epoetin with an enlarged administration interval has been attempted since the 1990s [4]. With the recent introduction of darbepoetin alfa as a once-weekly erythropoietin therapy [5], there has been a renewed interest in the once-weekly therapy of high-dose epoetin. This study investigated whether once-weekly SC epoetin alfa was equivalent to twice- or thrice-weekly SC administration in maintaining anaemia correction in haemodialysis patients. Subject and method Patients This multicentre, open-label, randomized controlled study using two parallel groups was conducted between July 2004 and April Selected for the study were patients on C The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please journals.permissions@oxfordjournals.org
2 A comparison between once-weekly and twice- or thrice-weekly subcutaneous injection of epoetin alfa 3241 Fig. 1. Study design. Abbreviations: Hb, haemoglobin; SC, subcutaneous. regular maintenance haemodialysis (3 times per week) with h dialysis sessions. The patients baseline dialysis prescriptions were maintained for the study period after enrolment. A total of three types of dialyzers were used in the study. The most common dialyzer was the Fresenius F6 (used in about 80% of sessions). Patients were enrolled from five dialysis centres in Korea and randomized into the study by central randomization. Patients were stratified for the epoetin dose (50 100, or IU/kg/week). The study protocol was approved by the institutional review board (IRB) at each participating site and informed consent was obtained from all patients. Inclusion and exclusion criteria were evaluated the week before the start and at the end of the pre-study periods. Patients fulfilled all the following inclusion criteria: patients 18 years or older with renal anaemia on regular haemodialysis for at least 3 months; stable epoetin dosage (3,000 12,000 IU/week) over the previous 3 months; stable haemoglobin level between 9.0 and 12.0 g/dl in the 4-week pre-study period, and adequate iron status ( 20% of transferrin saturation and 100 ng/ml of ferritin). Exclusion criteria were uncontrolled hypertension (mean diastolic blood pressure >110 mmhg), severe hyperparathyroidism indicated by a serum parathyroid hormone level >800 pg/ml, acute infection or systemic inflammatory disease, malignancy, or epilepsy, severe congestive heart failure (New York Heart Association Class III, IV), gastrointestinal bleeding in the previous 3 months, thrombocyte count greater than 500,000/µL, pregnancy, or lactation, use of androgen or immunosuppressive therapy in the last 3 months. Patients were also required not to have been administered a blood transfusion within the last 2 months, and to have no history of hypersensitivity to epoetin alfa. Dosage adjustment Patients entered a 4-week pre-study period to assess baseline haemoglobin level under stable conditions. During the pre-study period, patients received epoetin alfa (Espogen R ; LG Life Science Co., Ltd., Seoul, Korea) two or three times weekly through SC injection and the weekly epoetin alfa dosage was adjusted in order to maintain the haemoglobin level at g/dl for 4 weeks. The starting dose of epoetin alfa for the treatment period was the individual weekly dose of epoetin alfa during the prestudy period. Patients were randomly assigned to either once-weekly SC epoetin alfa or to their original two or three times weekly administration regimen (control group) for 12 weeks. The study design is presented schematically in Figure 1. SC epoetin alfa was administered after each dialysis session in the twice- or thrice-weekly group and after second dialysis session of each week in the once-weekly group. The dose of epoetin alfa used was expressed as the weekly units per body weight after dialysis (IU/kg/week). During the study treatment period, the haemoglobin level of each patient was maintained within the target range of g/dl by adjusting the dose of epoetin alfa. During the treatment period, a 25% increase in epoetin alfa dose was allowed if there was a decrease in haemoglobin >1g/dL from the previous level. The epoetin alfa dose was reduced by 25% after an increase in haemoglobin 1 g/dl compared with the previous value. The epoetin alfa dose was increased by 25% if the haemoglobin level was <9 g/dl, and reduced by 50% if a haemoglobin level of >12 g/dl was recorded. During the treatment period, intravenous iron preparation was supplemented if necessary (transferrin saturation is <20% or ferritin level <100 ng/ml). Assessments of efficacy and safety The following variables were recorded in all subjects: haemoglobin and haematocrit were measured every two weeks; serum iron, ferritin, transferrin saturation, serum electrolyte, liver transaminase and C-reactive protein were recorded every 4 weeks; serum parathyroid hormone level, chest X-ray and electrocardiogram were also recorded. The primary efficacy variable was the mean haemoglobin level at week 12. Secondary outcome variables were the mean epoetin alfa dose at week 10 and the proportion of patients who maintained a stable haemoglobin level ( 9.0 g/dl) without requiring an increase in total weekly
3 3242 Y. K. Lee et al. Table 1. Patient characteristics at baseline (mean ± SD) Once-weekly group Control group ITT (n = 44) Per protocol (n = 40) ITT (n = 39) Per protocol (n = 35) Sex (M:F) 24:20 23:17 23:16 21:14 Age (years) 55.7 ± ± ± ± 13.5 Body weight (kg) 57.2 ± ± ± ± 11.2 Haemoglobin (g/dl) 10.7 ± ± ± ± 0.7 Haematocrit (%) 32.0 ± ± ± ± 2.3 Ferritin (ng/ml) ± ± ± ± Transferrin saturation (%) 29.8 ± ± ± ± 16.6 i-pth (pg/ml) ± ± ± ± Kt/V 1.47 ± ± ± ± 0.28 Duration of dialysis (months) 41.9 ± ± ± ± 45.8 Cause of renal failure Diabetes mellitus 21/44 (47.7%) 18/40 (45.0%) 20/39 (51.3%) 18/35 (51.4%) Hypertension 17/44 (38.6%) 17/40 (42.5%) 12/39 (30.8%) 10/35 (28.6%) Glomerulonephritis 6/44 (13.6%) 5/40 (12.5%) 5/39 (12.8%) 5/35 (14.3%) Others 0/44 0/44 2/39 (5.1%) 2/35 (5.7%) Epoetin dose (IU/kg/week) ± ± ± ± 49.6 dose. Safety variables assessed were the patient s compliance to epoetin alfa, blood pressure and adverse events. Statistical analysis It was estimated that a sample size of 27 patients per treatment group would enable 80% power to detect a decrease of 0.75 g/dl in the haemoglobin level [6]. Assuming a dropout rate of 20%, a total of 34 patients per treatment group had to be enrolled. A two-sample t-test was used to compare differences in the haemoglobin, haematocrit and weekly epoetin alfa dose. Comparisons between treatment groups were carried out using the χ 2 -test to assess whether there was any significant difference between groups in the number of patients who maintained stable haemoglobin levels without increase in the epoetin dose. The main conclusions are based on the results for the intention-to-treat (ITT) population, although results for the per-protocol population are also given. Measured values of the results were expressed in average ± standard deviation. Interval estimates of differences between treatments are given as 95% confidence levels. A significant level of 5% was considered statistically significant. Data were recorded using Microsoft Excel R (Microsoft Corporation, Redmond, WA, USA) and all calculations were carried out using the SAS System version 6.10 (SAS institute, Cary, NC, USA). Results A total of 146 patients were included in the pre-study period. As 63 patients discontinued the study during screening, 83 patients completed the pre-study period. Eighty-three patients were randomly assigned to either once-weekly group (n = 44) or control group (n = 39), who continued with their previous dose of epoetin alfa twice or thrice weekly. Of the 44 patients randomized to once-weekly administration, 27 had received epoetin alfa twice weekly in the pre-study period and 17 had received the drug three times weekly. In the control group, 27 and 12 patients received epoetin alfa two or three times weekly, respectively. The causes of renal failure in the randomized population were diabetes mellitus (41 patients), hypertensive renal disease (29), chronic glomerulonephritis (11) and uraemia of unknown origin (2). Patient demographics and baseline characteristics are listed in Table 1. There were no significant differences in sex, age, body weight, duration of dialysis, haemoglobin, haematocrit, ferritin and transferrin saturation between the two groups. Mean Kt/V values were 1.47 ± 0.28 in the once-weekly group compared with 1.43 ± 0.27 in controls. A total of 75 patients (40 in the once-weekly group and 35 in the control group) completed a 12-week study and were evaluated for efficacy. Four patients (9.1%) in the once-weekly group and four controls (11.4%) were withdrawn from the evaluation prior to week 12 for the following reasons: protocol violation in four patients (dose change in the study period, two patients; haemoglobin level >12.0 g/dl at randomization, one patient and once-weekly therapy at randomization, one patient); adverse events unrelated epoetin alfa treatment in three patients (cerebral haemorrhage, two patients; coronary artery disease, one patient); withdrawn owing to transplantation in one patient. Patient deposition is summarized in Figure 2. There was no statistically significant difference between groups in the number of patients who maintained stable haemoglobin levels ( 9.0 g/dl) without an epoetin alfa dose increase (P = 0.75). In the majority of patients (once-weekly group, 95.0%, control group, 91.4%), stable haemoglobin levels were maintained without increase in the epoetin dose. The epoetin alfa dose was reduced in 23 out of 40 (57.5%) patients in the once-weekly group and in 21 out of 35 (60.0%) patients in the control group. At randomization, the mean haemoglobin level in onceweekly group was 10.7 ± 0.8 g/dl compared with 10.5 ± 0.7 g/dl among controls. At the initiation of treatment, the haemoglobin levels at weeks 4, 8 and 12 were 11.1 ± 1.1, 11.3 ± 1.3 and 11.0 ± 1.1 g/dl, respectively, in the once-weekly group and 11.3 ± 0.9, 11.5 ± 1.4 and 11.3 ± 1.5 g/dl, respectively, in the control group
4 A comparison between once-weekly and twice- or thrice-weekly subcutaneous injection of epoetin alfa 3243 Table 2. Epoetin alfa dose and haemoglobin concentration at baseline and weeks 4, 8, 12 (mean ± SD) Once-weekly group (n = 44) Control group (n = 39) Assessment Epoetin dose (IU/kg/week) Haemoglobin (g/dl) Epoetin dose (IU/kg/week) Haemoglobin (g/dl) Week ± ± ± ± 0.7 Week ± ± ± ± 0.9 Week ± ± ± ± 1.4 Week ± ± ± ± 1.5 Table 3. Mean haemoglobin concentration, haematocrit and epoetin alfa dose for the protocol population (n = 75) Fig. 2. Patient deposition. Once-weekly group (n = 40) Control group (n = 35) Mean Change Mean (90% CI) Change (90% CI) Haemoglobin (g/dl) Baseline Week (0.04, 0.60) (0.38, 1.20) Haematocrit (%) Baseline Week (0.20, 2.00) (1.20, 3.48) Epoetin dose (IU/kg/week) Baseline Week ( 40.39, 14.29) ( 35.39, 16.05) Fig. 3. Mean haemoglobin (A) and haematocrit (B) in both groups remained stable throughout the study (mean ± SD). (Figure 3A). There were no statistically differences in mean haemoglobin levels between groups. The haemoglobin level in the once-weekly group was significantly higher at weeks 4 and 8 than the baseline (P < 0.01) and that in the control group was higher at weeks 4, 8 and 12 than the baseline (P < 0.01). At randomization, the mean haematocrit level in once-weekly group was 32.0 ± 2.4% compared with 31.2 ± 2.4% among controls. At the initiation of treatment, the haematocrit levels at weeks 4, 8 and 12 were 32.9 ± 3.3, 33.2 ± 3.7 and 32.9 ± 3.4%, respectively, in the onceweekly group and 33.0 ± 3.1, 33.7 ± 4.4 and 33.5 ± 4.4%, respectively, in the control group (Figure 3B). There were no statistically differences in mean haematocrit levels between groups. The mean weekly epoetin alfa doses are shown for the two groups in Table 2. In the once-weekly group, the mean weekly dose of epoetin alfa was ± 69.6 IU/kg at the end point of the study compared with ± 64.8 IU/kg at baseline, a change of 26.8%. In the control group, the mean weekly dose of epoetin alfa was 96.1 ± 52.8 IU/kg at the end point of the study compared with ± 50.4 IU/kg at baseline, a change of 25.2%. The mean dose of epoetin alfa was slightly higher in the onceweekly group compared with controls. But, the changes in the mean dose of epoetin alfa between two groups for weeks 0 12 were not statistically significant. In the protocol population, the mean changes in the haemoglobin concentration from baseline to week 12 (0.32 and 0.79 g/dl in the once-weekly and the control group, respectively) and 90% CI of these changes ( and , respectively) were within the specified equivalence range in both groups (±0.75 g/dl) (Table 3). From baseline to week 12, a mean change of weekly epoetin alfa doses of IU/kg/week was observed in the once-weekly group and IU/kg/week in the control group. At randomization, the mean serum ferritin level in onceweekly group was ± ng/ml compared with ± ng/ml among controls. The ferritin level at weeks 4, 8 and 12 was ± 440.9, ± and ± ng/ml, respectively, in the once-weekly group and ± 329.0, ± and ± ng/ml, respectively, in the control group. Though
5 3244 Y. K. Lee et al. Fig. 4. Change of blood pressure during the study period. indicates that the difference between two groups is significant at P < Table 4. Adverse events occurring in >5% of patients Adverse events Once-weekly group (n = 44) Control group (n = 39) Hypertension 8 (18.2%) 7 (17.9%) Headache 3 (6.8%) 7 (17.9%) Chest pain 2 (4.5%) 4 (10.3%) Dizziness 4 (9.1%) 3 (7.7%) Paraesthesia 4 (9.1%) 9 (23.1%) Abdominal pain 4 (9.1%) 5 (12.8%) Constipation 4 (9.1%) 3 (7.7%) Dyspepsia 8 (18.2%) 5 (12.8%) Muscle weakness 1 (2.3%) 4 (10.3%) Myalgia 8 (18.2%) 3 (7.7%) Cough 5 (11.4%) 5 (12.8%) URI 21 (47.7%) 17 (43.6%) Injection site inflammation 4 (9.1%) 2 (5.1%) the once-weekly group showed a slightly higher level, no significant difference was observed. Also, the transferrin saturation at randomization was 29.8 ± 12.8% in the onceweekly group and 35.4 ± 16.4% in controls. Mean transferrin saturation values at weeks 4, 8 and 12 were 30.0 ± 12.4, 30.4 ± 15.7 and 31.3 ± 15.9%, respectively, in the once-weekly group and 36.4 ± 19.6, 36.5 ± 18.8 and 33.0 ± 17.4%, respectively, in the control group. The mean transferrin saturation values were slightly lower in the onceweekly group compared with controls. But, the changes in mean transferrin saturation values between two groups for weeks 0 12 were not statistically significant. While systolic blood pressure before the clinical trial was higher in the once-weekly group than the control group (P = 0.03), there was no significant difference between groups in both systolic and diastolic blood pressure during the trial (Figure 4). Epoetin alfa given once weekly was well tolerated, and there was no requirement for an increase in antihypertensive treatment compared with controls. In the biochemical test, including serum electrolyte, liver transaminase and C-reactive protein, no significant change was observed throughout the study period. No remarkable change was noted in chest X-ray and electrocardiogram before and after the administration of epoetin alfa. There were no clinically significant differences in the numbers and types of adverse events observed in the onceweekly group and control group. Table 4 lists adverse events that occurred in more than 5% of patients. Most adverse events were considered by the investigators to be unrelated to epoetin alfa and disappeared in time without any treatment. Serious adverse events were reported in more patients in the control group than once-weekly group (25.6% versus 20.5% of patients, respectively). These adverse events in the once-weekly group included inflammation at the injection site was reported in four patients; cardiovascular disease in three patients, gastric ulcer in one patient and diabetes mellitus in one patient. In the control group, inflammation at the injection site was reported in four patients; cardiovascular disease, nervous system disorder, hypoglycemia, musculoskeletal disorder, infection and urinary disease were reported in one patient each. Cerebral haemorrhage occurred in one patient in the once-weekly group and one patient in controls, and sepsis was reported in one patient in the control group; these were not considered to be related to the study medication. Discussion These results show that once-weekly SC administration of epoetin alfa is as effective and safe as two or three times weekly administration in maintaining a stable haemoglobin level. Although it might be expected that a reduction in dosage frequency would lead to a reduction in haemoglobin levels in the once-weekly group, there was no statistically significant difference in average weekly dose of epoetin alfa between two groups. On week 12, the average weekly dose of epoetin alfa in the once-weekly group was ± 69.6 IU/kg and 96.1 ± 52.8 IU/kg in the control group. From baseline to week 12, a mean change of weekly epoetin alfa doses of 38.3 IU/kg/week ( 26.8%) was observed in the once-weekly group and 32.3 IU/kg/week ( 25.2%) in the control group. With the recent introduction of darbepoetin alfa as a once-weekly erythropoietin therapy, various reports of once-weekly treatment of high-dose epoetin appeared, particularly epoetin beta. Two large-scale, randomized trials of epoetin beta treatment in stable haemodialysis patients demonstrated no change in erythropoietic response or epoetin beta dose with once-weekly administration [7,8]. The first of these studies was an open-label comparison of once-weekly dosing of epoetin beta compared with twice- or thrice-weekly dosing [7]. The second study was a therapeutic-equivalence study again comparing onceweekly treatment of epoetin beta with twice- or thriceweekly administration [8]. However, in other studies on dialysis patients, the required dose tended to be increased when the administration frequency of epoetin beta was decreased from three times weekly to once weekly [9]. Until recently, only clinical studies with limited numbers of patients had reported on the once-weekly epoetin alfa regimen [10 12]. Two multicentre studies with onceweekly epoetin alfa have also recently been reported. A prospective, open-label study by Provenzano et al. [13] evaluated the efficacy of 16 weeks of treatment with onceweekly SC epoetin alfa in patients with chronic kidney disease not on dialysis. This study was uncontrolled, but suggested that once-weekly epoetin alfa therapy was possible in some patients with chronic kidney disease. A crossover, intraindividual comparison study was reported
6 A comparison between once-weekly and twice- or thrice-weekly subcutaneous injection of epoetin alfa 3245 comparing the efficacy of SC epoetin alfa administered once weekly and three times weekly to haemodialysis patients [14]. With once-weekly administration of epoetin alfa, the haemoglobin concentrations were maintained in 79% of haemodialysis patients, and only minimal dose adjustments were required. In our study, there was no significant difference in the mean haemoglobin level between the once-weekly and twice- or thrice-weekly group, and the stable haemoglobin level was maintained in more than 90% of the patients without the increase of the epoetin dose. The results of the present study show that a small portion of haemodialysis patients required an increase of the epoetin dose to maintain a stable haemoglobin level compared with other studies. It may be possible that relatively short treatment periods have resulted in more patients achieving haemoglobin maintenance. During the study, the dose of epoetin alfa tended to decrease along time both in the once-weekly group and the control group. The acceptance criteria of Korean National Health Insurance Cooperation (KNHIC) for epoetin was a serum haemoglobin level <10 g/dl. The administration of epoetin alfa was not reimbursed by KNHIC if the haemoglobin level exceeded 10 g/dl. Before pre-study period, we had to decrease the dose or interrupt the administration of epoetin in those cases, which resulted in unexpectedly reduced haemoglobin levels of under 9.0 g/dl unexpectedly in some cases. Therefore, we had to exclude many patients because the haemoglobin level fell below 9 g/dl during the pre-study period. The patients with relatively high-dose epoetin alfa could be included. Difference in the haemoglobin level between the study protocol and KNHIC resulted in the reduction in the epoetin alfa dose in both groups over time of the study. The effect of epoetin alfa administration can be affected by various factors. Iron supply is an important factor for epoetin therapy [15]. For this reason, the iron store was checked every 4 weeks in this study and the intravenous iron supplementation was provided, as required. Use of intravenous iron probably contributed to the effect of once-weekly therapy of epoetin alfa in this study. In a survey of 44,333 Korean patients with end-stage renal disease in 2006, 89% of haemodialysis patients and 79% of peritoneal dialysis patients have been prescribed epoetin [16]. Epoetin is a relatively expensive drug and obtaining maximal response to epoetin therapy is an important issue in an economical aspect. Compared with two or three times weekly administration, once-weekly SC injection of highdose epoetin alfa achieves a similar effect on the patients haemoglobin levels. The possibility of switching the dosing regimen of epoetin alfa from twice or thrice weekly to once weekly without a change of haemoglobin concentration has practical advantages to both patients and healthcare workers. Less frequent administration of high-dose epoetin alfa potentially improves compliance to treatment. In addition, a simple dose schedule may reduce the nursing time and healthcare costs. An economical benefit is also expected via a decrease in drug costs, since the price per unit of high-dose epoetin alfa preparation is cheaper than that of low dose preparation. Limitations of our study were that the study period was short and the sample size was relatively small. As the quantitative assessment of erythropoiesis during epoetin treatment reveals a gradually increased haemoglobin level to reach a plateau within 6 12 weeks [17], the patients in our study were evaluated for 12 weeks. In conclusion, the study demonstrated that the efficacy and safety of high dose of epoetin alfa, when administered once weekly, were comparable to 2 3 times weekly therapy. Also, once-weekly therapy using high-dose epoetin alfa is beneficial for costs of nursing time and healthcare. Therefore, once-weekly therapy using high dose of epoetin alfa is considered to be an efficient method in stable haemodialysis patients. Acknowledgements. The authors wish to acknowledge the contributions of the following individuals to this study: the nurses in dialysis centres in Kangnam Sacred Heart Hospital, Hangang Sacred Heart Hospital, Kangdong Sacred Heart Hospital, Chuncheon Sacred Heart Hospital and Hallym University Sacred Heart Hospital, and staffs in CNR Research Co. Ltd. This study was supported by LG Life Science Co. Ltd. Conflict of interest statement. None declared. References 1. Canadian Erythropoietin Study Group. Association between recombinant human erythropoietin and quality of life and exercise capacity of patients receiving haemodialysis. BMJ 1990; 300: Besarab A, Reyes CM, Hornberger J. Meta-analysis of subcutaneous versus intravenous epoetin in maintenance treatment of anemia in hemodialysis patients. Am J Kidney Dis 2002; 40: Kaufman JS, Reda DJ, Fye CL et al. Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients. NEnglJMed1998; 339: Macdougall IC. Once-weekly erythropoietic therapy: is there a difference between the available preparations? Nephrol Dial Transplant 2002; 17: Locatelli F, Canaud B, Giacardy F et al. Treatment of anaemia in dialysis patients with unit dosing of darbepoetin alfa at a reduced dose frequency relative to recombinant human erythropoietin (rhuepo). Nephrol Dial Transplant 2003; 18: Canaud B, Bennhold I, Delons S et al. What is the optimum frequency of administration of r-huepo for correcting anemia in hemodialysis patients? Dial Transplant 1995; 24: Weiss LG, Clyne N, Divino Fihlho J et al. The efficacy of once weekly compared with two or three times weekly subcutaneous epoetin beta: results from a randomized controlled multicentre trial. Swedish Study Group. Nephrol Dial Transplant 2000; 15: Locatelli F, Baldamus CA, Villa G et al. Once-weekly compared with three times-weekly subcutaneous epoetin beta: results from a randomized, multicenter, therapeutic-equivalence study. Am J Kidney Dis 2002; 40: Tolman C, Richardson D, Bartlett C et al. Structured conversion from thrice weekly to weekly erythropoietic regimens using a computerized decision-support system: a randomized clinical study. J Am Soc Nephrol 2005; 16: Ongkingco JR, Ruley EJ, Turner ME et al. Efficacy of once- versus thrice-weekly subcutaneous recombinant human erythropoietin in children receiving continuous cycling peritoneal dialysis. Am J Nephrol 1994; 14: Lago M, Perez-Garcia R, Garcia de Vinuesa MS et al. Efficiency of once-weekly subcutaneous administration of recombinant human
7 3246 Y. K. Lee et al. erythropoietin versus three times a week administration in hemodialysis patients. Nephron 1996; 72: Lui SF, Wong KC, Li PK et al. Once weekly versus twice weekly subcutaneous administration of recombinant human erythropoietin in haemodialysis patients. Am J Nephrol 1992; 12: Provenzano R, Garcia-Mayol L, Suchinda P et al. POWER Study Group. Once-weekly epoetin alfa for treating the anemia of chronic kidney disease. Clin Nephrol 2004; 61: Barre P, Reichel H, Suranyi MG et al. Efficacy of once-weekly epoetin alfa. Clin Nephrol 2004; 62: Macdougall IC, Tucker B, Thompson J et al. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int 1996; 50: Korean society of nephrology, registry committee. Renal replacement therapy in Korea Insan memorial dialysis registry Korean J Nephrol 2007; 26(Suppl 2): S459 S Beguin Y, Loo M, R Zik S et al. Quantitative assessment of erythropoiesis in haemodialysis patients demonstrates gradual expansion of erythroblasts during constant treatment with recombinant human erythropoietin. Br J Haematol 1995; 89: Received for publication: Accepted in revised form:
Once-weekly darbepoetin alfa is as effective as three-times weekly epoetin
Artigo Original ONCE-WEEKLY DARBEPOETIN ALFA IS AS EFFECTIVE AS THREE-TIMES WEEKLY EPOETIN Rev Port Nefrol Hipert 2004; 18 (1): 33-40 Once-weekly darbepoetin alfa is as effective as three-times weekly
More informationThe efficacy of intravenous darbepoetin alfa administered once every 2 weeks in chronic kidney disease patients on haemodialysis
Nephrol Dial Transplant (2006) 21: 2846 2850 doi:10.1093/ndt/gfl387 Advance Access publication 5 August 2006 Original Article The efficacy of intravenous darbepoetin alfa administered once every 2 weeks
More informationNephrology Dialysis Transplantation
Nephrol Dial Transplant (2000) 15 [Suppl 4]: 33 42 Nephrology Dialysis Transplantation European Best Practice Guidelines 9 13 Anaemia management Claude Jacobs, Walter H. Hörl, Iain C. Macdougall, Fernando
More informationThe clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
More informationCurrent situation and future of renal anemia treatment. FRANCESCO LOCATELLI
Antalya May 20, 2010 12 National Congress of Turkish Society of Hypertension and Renal Disease Current situation and future of renal anemia treatment. FRANCESCO LOCATELLI Department of Nephrology, Dialysis
More informationSYNOPSIS. Issue Date: 04 February 2009 Document No.: EDMS -USRA
SYNOPSIS Issue Date: 04 February 2009 Document No.: EDMS -USRA-10751204 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Johnson & Johnson Pharmaceutical Research & Development,
More informationThe clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
More informationScottish Medicines Consortium
Scottish Medicines Consortium epoetin zeta, 1000 IU/0.3ml, 2000 IU/0.6ml, 3000 IU/0.9ml, 4000 IU/0.4ml, 5000 IU/0.5ml, 6000 IU/0.6ml, 8000 IU/0.8ml, 10,000 IU/1.0ml, 20,000 IU/0.5ml, 30,000 IU/0.75ml and
More informationANEMIA & HEMODIALYSIS
ANEMIA & HEMODIALYSIS The anemia of CKD is, in most patients, normocytic and normochromic, and is due primarily to reduced production of erythropoietin by the kidney and to shortened red cell survival.
More informationScottish Medicines Consortium
Scottish Medicines Consortium epoetin theta, 1,000 IU/0.5mL, 2,000 IU/0.5mL, 3,000 IU/0.5mL, 4,000 IU/0.5mL, 5,000 IU/0.5mL, 10,000 IU/1mL, 20,000 IU/1mL, 30,000 IU/1mL solution for injection in pre filled
More informationThe clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
More informationIntravenous Iron Requirement in Adult Hemodialysis Patients
Intravenous Iron Requirement in Adult Hemodialysis Patients Timothy V. Nguyen, PharmD The author is a clinical pharmacy specialist with Holy Name Hospital in Teaneck, New Jersey. He is also an adjunct
More informationferric carboxymaltose 50mg iron/ml solution for injection/infusion (Ferinject ) SMC No. (463/08) Vifor Pharma UK Ltd
Resubmission ferric carboxymaltose 50mg iron/ml solution for injection/infusion (Ferinject ) SMC No. (463/08) Vifor Pharma UK Ltd 06 May 2011 The Scottish Medicines Consortium (SMC) has completed its assessment
More informationEFFECTIVE SHARE CARE AGREEMENT
Specialist details Patient identifier Name: Tel: EFFECTIVE SHARE CARE AGREEMENT For the specialist use of Erythropoietin Stimulating Agent (ESA) Therapy (formerly known as EPO) for the correction of Anaemia
More informationferric carboxymaltose 50mg iron/ml solution for injection/infusion (Ferinject ) SMC No. (463/08) Vifor Pharmaceuticals
ferric carboxymaltose 50mg iron/ml solution for injection/infusion (Ferinject ) SMC No. (463/08) Vifor Pharmaceuticals 17 December 2010 The Scottish Medicines Consortium (SMC) has completed its assessment
More informationAnemia in ESRD patients is effectively treated by the
Randomized Trial of Model Predictive Control for Improved Anemia Management Michael E. Brier,* Adam E. Gaweda, Andrew Dailey, George R. Aroff, and Alfred A. Jacobs *Department of Veterans Affairs, Louisville,
More informationA rationale for an individualized haemoglobin target
Nephrol Dial Transplant (2002) 17 [Suppl 6 ]: 2 7 A rationale for an individualized haemoglobin target Norman Muirhead University of Western Ontario, London, Ontario, Canada Abstract Despite the use of
More informationADVANCES. Annual reports from the Centers for. In Anemia Management. Anemia Management in the United States: Is There Opportunity for Improvement?
ADVANCES Vol. 1 No.1 22 We are pleased to introduce our newest NPA publication, Advances in Anemia Management. This quarterly publication will address contemporary issues relating to the treatment of anemia
More informationComparison of Usage and Effectiveness between Methoxy Polyethylene Glycol Epoetin Beta and Darbepoetin Alfa with Hemodialysis Patients
Journal of Pharmacy and Pharmacology 3 (2015) 182-190 doi: 10.17265/2328-2150/2015.04.004 D DAVID PUBLISHING Comparison of Usage and Effectiveness between Methoxy Polyethylene Glycol Epoetin Beta and Darbepoetin
More informationConversion Dosing Guide:
Conversion Dosing Guide: From epoetin alfa to Aranesp in patients with anemia due to CKD on dialysis Indication Aranesp (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney
More informationComparison of Erythropoietin and Darbepoetin in Chronic Kidney Disease Patients in a Tertiary Care Hospital
Human Journals Research Article July 2017 Vol.:9, Issue: 4 All rights are reserved by Pournami A S et al. Comparison of Erythropoietin and Darbepoetin in Chronic Kidney Disease Patients in a Tertiary Care
More informationROYAL WOLVERHAMPTON HOSPITALS NHS TRUST
ROYAL WOLVERHAMPTON HOSPITALS NHS TRUST SHARED CARE PROTOCOL FOR ERYTHROPOIETIN USE 2016 New Cross Hospital Dr J Odum Dr P B Rylance Dr P Carmichael Dr S Acton Dr B Ramakrishna Walsall Manor Hospital Dr
More informationComment on European Renal Best Practice Position Statement on Anaemia Management in Chronic Kidney Disease.
Comment on European Renal Best Practice Position Statement on Anaemia Management in Chronic Kidney Disease. Goldsmith D, Blackman A, Gabbay F, June 2013 Kidney Disease: Improving Global Outcomes (KDIGO)
More informationMaintenance intravenous iron therapy in pediatric hemodialysis patients Morgan H E, Gautam M, Geary D F
Maintenance intravenous iron therapy in pediatric hemodialysis patients Morgan H E, Gautam M, Geary D F Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion
More informationDarbepoetin alfa (Aranesp TM )inchildren with chronic renal failure
Kidney International, Vol. 68 (2005), pp. 1759 1765 Darbepoetin alfa (Aranesp TM )inchildren with chronic renal failure DENIS F. GEARY, LAURA E. KEATING, ANNETTE VIGNEUX, DEREK STEPHENS, DIANE HÉBERT,
More informationRegional variability in anaemia management and haemoglobin in the US
Nephrol Dial Transplant (2003) 18: 147 152 Original Article Regional variability in anaemia management and haemoglobin in the US Donal N. Reddan 1, Diane L. Frankenfield 2, Preston S. Klassen 1, Joseph
More informationAn Audit of Poor Response To Erythropoeitin Therapy. September 1998
1 An Audit of Poor Response To Erythropoeitin Therapy September 1998 Prepared By: Nicola Austerberry Renal Audit Facilitator Phil Kalra Consultant Nephrologist 2 1 Introduction The topic for this audit
More informationEfficacy and tolerability of oral Sucrosomial Iron in CKD patients with anemia. Ioannis Griveas, MD, PhD
Efficacy and tolerability of oral Sucrosomial Iron in CKD patients with anemia Ioannis Griveas, MD, PhD Anaemia is a state in which the quality and/or quantity of circulating red blood cells are below
More informationA meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients undergoing dialysis
NDT Plus (2009) 2: 347 353 doi: 10.1093/ndtplus/sfp097 Advance Access publication 4 August 2009 In-Depth Clinical Review A meta-analysis of the relative doses of erythropoiesis-stimulating agents in patients
More informationPFIZER INC. PROTOCOL TITLE: Growth hormone therapy in short children after renal transplantation for chronic renal failure in Germany.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationNATIONAL QUALITY FORUM Renal EM Submitted Measures
NATIONAL QUALITY FORUM Renal EM Submitted Measures Measure ID/ Title Measure Description Measure Steward Topic Area #1662 Percentage of patients aged 18 years and older with a diagnosis of CKD ACE/ARB
More informationNational Institute for Health and Care Excellence
National Institute for Health and Care Excellence 2-year surveillance (2017) Chronic kidney disease: managing anaemia (2015) NICE guideline NG8 Appendix A3: Summary of new evidence from surveillance Diagnostic
More informationErythropoiesis-stimulating Agents and Anemia in Patients with Non-dialytic Chronic Kidney Disease
ORIGINAL ARTICLE Nephrology http://dx.doi.org/1.3346/jkms.216.31.1.55 J Korean Med Sci 216; 31: 55- Erythropoiesis-stimulating Agents and Anemia in Patients with Non-dialytic Chronic Kidney Disease Sun
More informationClinical and Cost Effectiveness of Darbepoetin alfa in Cancer Treatment-induced Anaemia
Clinical and Cost Effectiveness of Darbepoetin alfa in Cancer Treatment-induced Anaemia 8 th November 2004 A report for the National Institute for Clinical Excellence prepared by Amgen Ltd. EXECUTIVE SUMMARY
More informationFuture Direction of Anemia Management in ESRD. Jay B. Wish, MD 2008 Nephrology Update March 20, 2008
Future Direction of Anemia Management in ESRD Jay B. Wish, MD 2008 Nephrology Update March 20, 2008 The Evidence Normal Hct Study and CHOIR demonstrate adverse outcomes in ESA patients with target Hgb
More informationEffective Health Care
Number 3 Effective Health Care Comparative Effectiveness of Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment Executive Summary Background Anemia (deficiency of red blood
More informationPeer Review Report. [erythropoietin-stimulating agents]
21 st Expert Committee on Selection and Use of Essential Medicines Peer Review Report [erythropoietin-stimulating agents] (1) Does the application adequately address the issue of the public health need
More informationCentocor Ortho Biotech Services, LLC
SYNOPSIS Issue Date: 17 June 2009 Name of Sponsor/Company Name of Finished Product PROCRIT Name of Active Ingredient(s) Protocol No.: PR04-15-001 Centocor Ortho Biotech Services, LLC Epoetin alfa Title
More informationINFLUENCE OF LOW PROTEIN DIET IN IMPROVING ANEMIA TREATED WITH ERYTHROPOETIN
INFLUENCE OF LOW PROTEIN DIET IN IMPROVING ANEMIA TREATED WITH ERYTHROPOETIN, Idrizi A, Barbullushi M, Gjyzari A, Duraku A Department of Nephrology, University Hospital Center, Tirana, Albania Introduction
More informationPublic Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended
Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended EPOETIN ALFA UK/WS/026/pd/WS/001 Rapporteur: UK Finalisation procedure
More informationDrugs Used in Anemia
Drugs Used in Anemia Drugs of Anemia Anemia is defined as a below-normal plasma hemoglobin concentration resulting from: a decreased number of circulating red blood cells or an abnormally low total hemoglobin
More informationIron Status in Chronic Renal Failure with Anemia
Chattagram Maa-O-Shishu Hospital Medical College Journal DOI: 10.11566/cmosh.2013.1201.12 Original Article Iron Status in Chronic Renal Failure with Anemia Shaheda Khanam 1 * Noorzahan Begum 2 AMM Ehteshamul
More informationErythropoiesis Stimulating Agents (ESAs): Epoetin Alfa * DIALYSIS *
Erythropoiesis Stimulating Agents (ESAs): Epoetin Alfa * DIALYSIS * DESCRIPTION Erythropoietin is a glycoprotein produced in the kidneys responsible for the stimulation of red blood cell production. Epoetin
More informationLeft ventricular hypertrophy: why does it happen?
Nephrol Dial Transplant (2003) 18 [Suppl 8]: viii2 viii6 DOI: 10.1093/ndt/gfg1083 Left ventricular hypertrophy: why does it happen? Gerard M. London Department of Nephrology and Dialysis, Manhes Hospital,
More informationTable 3. Sotatercept PK in ESKD Subjects on Hemodialysis (Dose 1, Cycle 1) Sotatercept. 0.3 mg/kg n= mg/kg n=6
Interim nalysis of CE--REN-: The First 8-Day Dose Cycle of Low and Medium Starting Doses of Compared to for Correction of nemia in Hemodialysis Subjects Mohamed El-Shahawy ; James Cotton ; Jeffrey Kaupke
More informationDose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study
Adv Ther (2013) 30:1007 1017 DOI 10.1007/s25-013-0063-y ORIGINAL RESEARCH Dose Conversion Ratio in Hemodialysis Patients Switched from Darbepoetin Alfa to PEG-Epoetin Beta: AFFIRM Study Peter Choi Mourad
More informationmean hemoglobin 11 g/dl (110 g/l) compared to patients with lower mean hemoglobin values (Table 20).
S44 Figure 53 depicts the trend in Epoetin dosing from the 1998 study period to the 2003 study period, with an increasing mean weekly Epoetin dose (units/kg/wk) for patients prescribed Epoetin in lower
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Dynepo 1,000 IU/0.5 ml solution for injection in a pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled
More informationUpdate on Chemotherapy- Induced Anemia and Neutropenia Therapies
Update on Chemotherapy- Induced Anemia and Neutropenia Therapies ASCO 2007: Update on Chemotherapy- Induced Anemia and Neutropenia Therapies Safety and efficacy of intravenous iron in patients with chemotherapyinduced
More informationOriginal Article. Introduction
Nephrol Dial Transplant (2004) 19: 121 132 DOI: 10.1093/ndt/gfg458 Original Article Anaemia in haemodialysis patients of five European countries: association with morbidity and mortality in the Dialysis
More informationRecombinant Human Erythropoietin in the Management of Anaemia in Chronic Kidney Disease Patients An Indian Multicentre Experience
ORIGINAL ARTICLE JIACM 2006; 7(3): 193-8 Recombinant Human Erythropoietin in the Management of Anaemia in Chronic Kidney Disease Patients An Indian Multicentre Experience Sanjay K Agarwal*, Sanjeev Saxena**,
More informationLiterature Scan: Erythropoiesis Stimulating Agents
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationEpogen / Procrit. Epogen / Procrit (epoetin alfa) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.10.06 Section: Prescription Drugs Effective Date: April1, 2014 Subject: Epogen / Procrit Page: 1 of 7
More informationHMO: Medical (provider setting); Rx (out patient) PPO/CDHP: Rx
BENEFIT DESCRIPTION AND LIMITATIONS OF COVERAGE ITEM: PRODUCT LINES: COVERED UNDER: DESCRIPTION: CPT/HCPCS Code: Company Supplying: Setting: Epogen, Procrit (epoetin alfa, injection) Commercial HMO/PPO/CDHP
More informationMIRCERA. INN: Methoxy polyethylene glycol-epoetin beta. Pre-filled syringe. Composition
MIRCERA INN: Methoxy polyethylene glycol-epoetin beta Pre-filled syringe Composition Single dose pre-filled syringes: containing 50µg, 75µg, 100µg, 150µg, 200µg, or 250µg methoxy polyethylene glycol-epoetin
More informationNew Aspects to Optimize Epoetin Treatment with Intravenous Iron Therapy in Hemodialysis Patients
23. Berliner DialyseSeminar 1.-4. Dezember 2010 New Aspects to Optimize Epoetin Treatment with Intravenous Iron Therapy in Hemodialysis Patients George R. Aronoff, MD, MS, FACP Professor of Medicine and
More informationRecombinant human epoetin beta in the treatment of renal anemia
REVIEW Recombinant human epoetin beta in the treatment of renal anemia Francesco Locatelli 1 Pietro Pozzoni 1 Lucia Del Vecchio 2 1 Department of Nephrology and Dialysis, A. Manzoni Hospital, Lecco, Italy;
More informationFINAL PACKAGE INSERT. Recombinant human erythropoietin (r-huepo) is a sterile phosphate-buffered solution for
FINAL PACKAGE INSERT SCHEDULING STATUS Schedule 4 PROPRIETARY NAMES AND DOSAGE FORMS Pre-filled syringes: EPREX 2 000 IU/0,5 ml EPREX 4 000 IU/0,4 ml EPREX 6 000 IU/0,6 ml EPREX 10 000 IU/ml EPREX 40 000
More informationThe safety and efficacy of an accelerated iron sucrose dosing regimen in patients with chronic kidney disease
Kidney International, Vol. 64, Supplement 87 (2003), pp. S72 S77 The safety and efficacy of an accelerated iron sucrose dosing regimen in patients with chronic kidney disease DANIEL A. BLAUSTEIN, MICHAEL
More informationPublished Online 2013 July 24. Research Article
Nephro-Urology Monthly. 2013 September; 5(4):913-7. Published Online 2013 July 24. DOI: 10.5812/numonthly.12038 Research Article Comparative Study of Intravenous Iron Versus Intravenous Ascorbic Acid for
More informationClinical Effect of Recombinant Human Erythropoietin (rhepo, Espogen TM ) in Anemia of Chronic Renal Failure Patients on Dialysis.
Clinical Effect of Recombinant Human Erythropoietin (rhepo, Espogen TM ) in Anemia of Chronic Renal Failure Patients on Dialysis. Biotech Research Center of LG Chemical Ltd., Korea Division of Nephrology,
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Methoxy polyethylene glycol-epoetin beta (Mircera) Reference Number: CP.CPA.322 Effective Date: 06.01.18 Last Review Date: 05.18 Line of Business: Commercial Coding Implications Revision
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Epoetin alfa HEXAL 1,000 IU/0.5 ml solution for injection in a pre-filled syringe Epoetin alfa HEXAL 2,000 IU/1 ml solution
More informationThe use of surrogates as key performance indicators
REPLY The use of surrogates as key performance indicators Dr José Vinhas Department of Nephrology, Centro Hospitalar de Setúbal. Setúbal, Portugal Received for publication: 24/08/2012 Accepted: 31/08/2012
More informationEPO e Ferro in Emodialisi: Il PBM al suo esordio. Lucia Del Vecchio. Divisione di Nefrologia e Dialisi Ospedale A. Manzoni, ASST Lecco
PATIENT BLOOD MANAGEMENT DALLA TEORIA ALLA PRATICA 16 FEBBRAIO 2018 EPO e Ferro in Emodialisi: Il PBM al suo esordio Lucia Del Vecchio Divisione di Nefrologia e Dialisi Ospedale A. Manzoni, ASST Lecco
More informationIN-CENTER HEMODIALYSIS (HD) CLINICAL PERFORMANCE MEASURES DATA COLLECTION FORM 2006
IN-CENTER HEMODIALYSIS (HD) CLINICAL PERFORMANCE MEASURES DATA COLLECTION FORM 2006 PATIENT IDENTIFICATION [Before completing please read instructions at the bottom of this page and on pages 5 and 6] MAKE
More informationCAN WE PREDICT THE RISK FOR ADVERSE EVENTS? Andrzej Wiecek, Katowice, Poland
CAN WE PREDICT THE RISK FOR ADVERSE EVENTS? Andrzej Wiecek, Katowice, Poland Chair: Kai- Uwe Eckardt, Erlangen, Germany Pierre- Yves Martin, Geneva, Switzerland Prof. Andrzej Więcek Departm ent of Nephrology,
More informationStudy of Management of anemia in Chronic Kidney Disease Patients
Review Article Study of Management of anemia in Chronic Kidney Disease Patients Meby Susan Mathew, Nama Ravi Sneha Keerthi, Neelathahalli Kasturirangan Meera* Meera N.K, Visveswarapura Institute of Pharmaceutical
More informationORIGINAL ARTICLE. Evaluation of Effect of Ascorbic Acid on Ferritin and Erythropoietin Resistance in Patients of Chronic Kidney Disease
32 Evaluation of Effect of Ascorbic Acid on Ferritin and Erythropoietin Resistance in Patients of Chronic Kidney Disease N Nand 1, S Venu 2, AR Deshmukh 2, R Mittal 2 ORIGINAL ARTICLE Abstract This study
More informationAnemia is a common complication of chronic kidney
Original Articles Epoetin Alfa Once Every 2 Weeks Is Effective for Initiation of Treatment of Anemia of Chronic Kidney Disease Robert Benz,* Rebecca Schmidt, Kathleen Kelly, and Marsha Wolfson *Division
More information2.0 Synopsis. Paricalcitol Capsules M Clinical Study Report R&D/15/0380. (For National Authority Use Only)
2.0 Synopsis AbbVie Inc. Name of Study Drug: ABT-358/Zemplar (paricalcitol) Capsules Name of Active Ingredient: paricalcitol Individual Study Table Referring to Part of Dossier: Volume: Page: (For National
More informationAETNA BETTER HEALTH Prior Authorization guideline for Erythropoiesis Stimulating Agents (ESA)
AETNA BETTER HEALTH Prior Authorization guideline for Erythropoiesis Stimulating Agents (ESA) Drugs Covered Procrit Epogen Aranesp Authorization guidelines For patients who meet all of the following: Does
More informationK atching Up with KDOQI: Clinical Practice Guidelines & Clinical Practice Recommendations for Anemia of Chronic Kidney Disease 2006
K atching Up with KDOQI: Clinical Practice Guidelines & Clinical Practice Recommendations for Anemia of Chronic Kidney Disease 2006 Why new guidelines? Rationale for KDOQI Anemia 2006 Expand scope to all
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Binocrit 1000 IU/0.5 ml solution for injection in a pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml
More informationAppropriateness of anemia management in hemodialysis patients
Saudi Pharmaceutical Journal (2012) 20, 85 91 King Saud University Saudi Pharmaceutical Journal www.ksu.edu.sa www.sciencedirect.com PRACTICE REPORT Appropriateness of anemia management in hemodialysis
More informationORIGINAL PAPER. Introduction
ORIGINAL PAPER Dosing strategies for conversion of haemodialysis patients from short-acting erythropoiesis stimulating agents to once-monthly C.E.R.A.: experience from the MIRACEL study F. Dellanna, 1
More informationThe Parsabiv Beginner s Book
The Parsabiv Beginner s Book A quick guide to help you learn about your treatment with Parsabiv and what to expect Indication Parsabiv (etelcalcetide) is indicated for the treatment of secondary hyperparathyroidism
More informationAnemia response to Methoxy
Open Access Journal of Clinical Nephrology Research Article Anemia response to Methoxy ISSN 2576-9529 Polyethylene Glycol-Epoetin Beta (Mircera) versus Epoetin Alfa (Eprex) in patients with chronic Kidney
More informationMaintenance of target hemoglobin level in stable hemodialysis patients constitutes a theoretical task: a historical prospective study
original article http://www.kidney-international.org & 2008 International Society of Nephrology Maintenance of target hemoglobin level in stable hemodialysis patients constitutes a theoretical task: a
More informationTransfusion. National Clinical Guideline Centre. Blood transfusion. Clinical guideline. November Final version.
National Clinical Guideline Centre 1 Final version Transfusion Blood transfusion Clinical guideline Appendices H-I November 2015 Final version Commissioned by the National Institute for Health and Care
More informationAnemia Management in Peritoneal Dialysis Patients Pranay Kathuria, FACP, FASN
Anemia Management in Peritoneal Dialysis Patients Pranay Kathuria, FACP, FASN Professor of Medicine Director, Division of Nephrology and Hypertension University of Oklahoma College of Medicine Definition
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Darbepoetin Alfa (Aranesp) Reference Number: CP.PHAR.236 Effective Date: 06.01.16 Last Review Date: 05.18 Line of Business: HIM, Medicaid Coding Implications Revision Log See Important
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Retacrit 1000 IU/0.3ml solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pre-filled
More informationIntravenous Iron: A Good Thing Made Better? Marilyn Telen, MD Wellcome Professor of Medicine Duke University
Intravenous Iron: A Good Thing Made Better? Marilyn Telen, MD Wellcome Professor of Medicine Duke University Use of IV Iron There are increasing data regarding safety of IV iron. IV iron is superior to
More informationOriginal Article Anemia management trends in patients on peritoneal dialysis in the past 10 years
Int J Clin Exp Med 2015;8(10):18050-18057 www.ijcem.com /ISSN:1940-5901/IJCEM0011104 Original Article Anemia management trends in patients on peritoneal dialysis in the past 10 years Huaye Liu, Yao Yao,
More informationTo report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc., a Pfizer company, at , or FDA at FDA-1088 or
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RETACRIT safely and effectively. See full prescribing information for RETACRIT. RETACRIT (epoetin
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Centre for Clinical Practice
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for Clinical Practice Review consultation document Review of Clinical Guideline (CG) CG 114: Anaemia management in Chronic Kidney Disease. Background
More informationIron Supplementation and Erythropoiesis-Stimulatory Agents in the Treatment of Cancer Anemia
Iron Supplementation and Erythropoiesis-Stimulatory Agents in the Treatment of Cancer Anemia Paolo Pedrazzoli, MD 1, Giovanni Rosti, MD 2, Simona Secondino, MD 1, and Salvatore Siena, MD 1 Unresponsiveness
More informationAnemia is very common among end-stage renal fail LATEST STRATEGY IN RENAL ANEMIA MANAGEMENT IN PERITONEAL DIALYSIS PATIENTS.
Proceedings of the 3rd Asian Chapter Meeting of the ISPD November 22 24, 2007, Hiroshima, Japan Peritoneal Dialysis International, Vol. 28 (2008), Supplement 3 0896-8608/08 $3.00 +.00 Copyright 2008 International
More informationEvaluation of the effect of oral versus intravenous iron treatments on anemia in patients with chronic kidney diseases.
Evaluation of the effect of oral versus intravenous iron treatments on anemia in patients with chronic kidney diseases. Arif Sami Malik FICMS. Abstract Background:Correction of anemia as a result of renal
More informationClinical Study Synopsis
Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace
More informationNon-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document.
ERYTHROPOIESIS-STIMULATING AGENTS (ESAs) Epoetin alfa (Epogen, Procrit ) Darbepoetin alfa (Aranesp ) Methoxy polyethylene glycol (PEG) epoetin-beta (Mircera ) Non-Discrimination Statement and Multi-Language
More informationAnemia of Chronic Disease
J KMA Special Issue Anemia of Chronic Disease Chul Soo Kim, MD Department of Internal Medicine, Inha University College of Medicine Email : cskimmd@inha.ac.kr J Korean Med Assoc 2006; 49(10): 920-6 Abstract
More informationInternational Journal of Current Research in Chemistry and Pharmaceutical Sciences Volume 1 Issue: Pages: 20-28
International Journal of Current Research in Chemistry and Pharmaceutical Sciences www.ijcrcps.com Volume 1 Issue: 3 2014 Pages: 20-28 (p-issn: 2348-5213; e-issn: 2348-5221) REVIEW ARTICLE PREVALENCE OF
More informationChanges in anemia management and hemoglobin levels following revision of a bundling policy to incorporate recombinant human erythropoietin
http://www.kidney-international.org & 11 International Society of Nephrology see commentary on page 265 Changes in anemia management and hemoglobin levels following revision of a bundling policy to incorporate
More informationStages of chronic kidney disease
For mass reproduction, content licensing and permissions contact Dowden Health Media. Jonathan J. Taliercio, DO Department of Nephrology and Hypertension, Cleveland Clinic, Cleveland, Ohio talierj@ccf.org
More informationNo Disclosures 03/20/2019. Learning Objectives. Renal Anemia: The Basics
Renal Anemia: The Basics Meredith Atkinson, M.D., M.H.S. Associate Professor of Pediatrics Johns Hopkins School of Medicine 16 March 2019 No Disclosures Learning Objectives At the end of this session the
More informationProtocol GTC : A Randomized, Open Label, Parallel Design Study of Sevelamer Hydrochloride (Renagel ) in Chronic Kidney Disease Patients.
Protocol GTC-68-208: A Randomized, Open Label, Parallel Design Study of Sevelamer Hydrochloride (Renagel ) in Chronic Kidney Disease Patients. These results are supplied for informational purposes only.
More informationPREDICTION OF RESPONSE TO OPTIMIZE OUTCOME OF TREATMENT WITH ERYTHROPOIETIN. Yves Beguin
PREDICTION OF RESPONSE TO OPTIMIZE OUTCOME OF TREATMENT WITH ERYTHROPOIETIN Yves Beguin Senior Research Associate of the National Fund for Scientific Research (FNRS, Belgium). Department of Medicine, Division
More informationSummary of Recommendation Statements Kidney International Supplements (2012) 2, ; doi: /kisup
http://www.kidney-international.org & 2012 KDIGO Summary of Recommendation Statements Kidney International Supplements (2012) 2, 283 287; doi:10.1038/kisup.2012.41 Chapter 1: Diagnosis and evaluation of
More information