Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar 2019 16:29:06 GMT) CTRI Number CTRI/2010/091/000679 [Registered on: 23/08/2010] - Last Modified On 10/07/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients (ELEVATE) A 24-month, multi-center, open-label, randomized, controlled trial to investigate efficacy, safety and evolution of cardiovascular parameters in de novo renal transplant recipients after early calcineurin inhibitor to everolimus conversion Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) CRAD001A2429 NCT01114529 Protocol Number ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Details Contact Person (Scientific Query) Murugananthan K Head-Clinical Development Phone 022-24958545 Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai Mumbai MAHARASHTRA 400 018 murugananthan.k@novartis.com Details Contact Person (Public Query) Murugananthan K Head- Clinical Department Novartis Healthcare Private Limited, Medical Department, Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai Mumbai MAHARASHTRA 400 018 page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone 022-24958545 > Novartis Pharma AG,Basel,Switzerland Type of Sponsor Nil List of Countries Germany of Principal Investigator DrVinoi George David Dr. S.Sundar Dr. R K Sharma Dr Dinesh Khullar murugananthan.k@novartis.com Source of Monetary or Material Support Primary Sponsor Details Novartis Healthcare Pvt Ltd Medical Department, Sandoz House, Shiv Sagar Estate,Dr. Annie Besant Rd, Worli, Mumbai- 400018 Pharmaceutical industry-global of Site Site Phone// Christian Medical College (CMC) Columbia Asia Referral Hospital Department of Nephrology, Sanjay Gandhi Post graduate Institute of Medical Sciences Dept of Nephrology,Sir Ganga Ram Hospital Department of Nephrolo gy,bhagayam,vellore - 632 004 Tamil Nadu Vellore TAMIL NADU Yeshwanthpur,#26/1,Bri gade Gateway, Beside Metro, -560055 Bangalore KARNATAKA Raebareli Road,,-226014 Lucknow UTTAR PRADESH Rajinder Nagar,,-110060 New Delhi DELHI DrCMThiagrajan Fortis Malar Hospitals No.52, 1st Main Road, Adyar, Chennai- 600 020 Chennai TAMIL NADU Dr. Sanjeev Jasuja Indraprastha Apollo Hospital Sarita Vihar,,Mathura Road, -110044 New Delhi DELHI DrRavi Shankar Seven Hills Hospitals Department of Nephrology, Consultant Nephrologist & Transplant Physician, Rockdale Layout,Visak hpatnam-531022,india Visakhapatnam ANDHRA PRADESH 919894039248 vinoigd@hotmail.com?91 9986050646 sundar_s@vsnl.com?91 522 2668004 rksharma@sgpgi.ac.in?91 11 25750000 "drdineshkhullar@gmail.com 919840183886 drcmthiagarajan@gmail.com?91 9811111455 Sanjiv_Jasuja@hotmail. com 919866202945 ravi.shankar.s.dr@gmai l.com page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria of Committee Approval Status Date of Approval Is Independent Ethics Committee? CLINICOM, Bangalore Approved 13/12/2010 Yes Ethical Comittee,Sir Ganga Ram Hospital Ethics Commitee,Christian Medical College Ethics Committee on Clinical Trials, Institutional Ethics Committee Institutional Ethics Committee, Columbia Asia Hospitals Approved 26/11/2010 No Approved 31/08/2011 No Approved 21/07/2010 Yes Approved 02/11/2010 No Approved 05/08/2010 No Seven Hills Hospitals Approved 10/06/2011 Yes Status Date Approved/Obtained 06/08/2010 Health Type Patients Condition Renal Transplantation Type Details Intervention Everolimus 6 to 10 ng/ml(target dose given by PI)Twice a day orally at 12-hour intervals for 22 months. in combination with mycophenolate sodium and steroids Comparator Agent Tacrolimus or Cyclosporine Tacrolimus-Dosage ranges 5-10 ng per ml Cyclosporine- 100 to 250ng per ml both given twice daily, orallyat 12-hour intervals for 22 months Age From Age To Gender Details 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria Inclusion Criteria at Baseline: Male or female renal allograft recipients at least 18 years old. Written informed consent. Patient receiving a primary or secondary kidney transplant from a cadaveric or living unrelated-/related donor. Cold ischemia time (CIT) less than 24 hours. Negative pregnancy test for female patients. Inclusion Criteria at Randomization: Patients on CNI (TAC or CsA) + Myfortic + steroids. Serum creatinine less than 2.8 mg/dl (250 mol/l) and an actual egfr (MDRD4)greater than or equal to 25 ml/min/1.73m exp2 (without renal replacement therapy). Exclusion Criteria Details Exclusion Criteria Exclusion Criteria at Baseline: 1)Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 2)Recipient of multiple organ transplants. 3)Recipient of ABO incompatible allograft or a positive cross-match. 4)Panel Reactive Antibodies (PRA) level page 3 / 5
Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label greater than equal to 30 %. 5)Positive test for human immunodeficiency virus (HIV). 6)Patient receiving an allograft from a Hepatitis B surface Antigen (HBsAg) or a Hepatitis C Virus (HCV) positive donor. 7)HBsAg and/or a HCV positive patient with evidence of elevated LFTs (ALT/AST levels greater than equal to 2.5 times ULN). 8)Severe restrictive or obstructive pulmonary disorders. 9)Patient with severe allergy requiring acute or chronic treatment or hypersensitivity to any of the study drugs or similar drugs. 10)Severe hypercholesterolemia or hypertriglyceridemia. 11)Low platelet count. 12)Low white blood cell count. 13)History of malignancy of any organ system Exclusion Criteria at Randomization: 14)Graft loss. 15)Patient on renal replacement therapy. 16)Patient who experienced severe humoral and/or cellular rejection (BANFF greater than equal to IIb). 17)Patient with greater than equal to 2 episodes of AR or an AR episode that needed antibody treatment. 18)Patient with ongoing or currently treated AR (2 weeks prior to randomization). 19)Proteinuria greater 1 g/day. 20)Patients with recurrence of Focal Segmental Glomerulosclerosis (FSGS). 21)Low platelet count; Low white blood cell count; Low absolute neutrophil count; Low hemoglobin. 22)Severe liver disease. 23)Systemic infection requiring continued therapy that would interfere with the objectives of the study. 24)Severe hypercholesterolemia or hypertriglyceridemia. 25)Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy. 26)Presence of intractable immunosuppressant complications or side effects. 27)Patients on anticoagulants that prevents renal allograft biopsy. 28)Use of prohibited medication. 29)Use of immunosuppressive agents not utilized in the protocol. 30)Pregnant or nursing (lactating) women. 31)Women of child-bearing potential not using a highly effective method of birth control. Primary Outcome Outcome Timepoints Assessment of renal function by estimated Glomerular Filtration Rate Time Frame: at 12 months post-transplantation Secondary Outcome Outcome Timepoints 1)Composite efficacy failure as treated biopsy proven acute rejection (BPAR ), graft loss or death 2)Improvement of Left Ventricular Hypertrophy (LVH) as assessed by LV mass index (LVMi) using echocardiogram 1)Time Frame: at 12 months post-transplantation 2)Time Frame: at 12 months post-transplantation. 3)Incidence, time to event and severity of treated 3)Time Frame: at 12 and 24 months BPAR greater than equal to IB; incidence of post-transplantation. BPAR that need antibody treatment; incidence of humoral rejection; incidence of treated BPAR greater than equal to IB. 4)Incidence, time to event and severity of any 4)Time Frame: at 12 and 24 months acute rejection (suspected AR, treated acute AR, post-transplantation. Biopsy AR, treated biopsy proven AR, subclinical AR). 5)Incidence of adverse events (AEs) and serious adverse events (SAEs) 5)Time Frame: at 12 and 24 months post-transplantation. page 4 / 5
Powered by TCPDF (www.tcpdf.org) Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=676 Sample Size from =50 26/11/2010 15/07/2010 Years=4 Months=6 Days=0 Completed Completed No Publications Provided Purpose od the Study: The purpose of this study is to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study is designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients Target no. of patients from is 71. FPFV in is 26th Nov 2010. page 5 / 5