TABLE OF CONTENTS Disclaimer Work Group Membership KDIGO Board Members Abbreviations and Acronyms Reference Keys Abstract Foreword

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2 TABLE OF CONTENTS Siii Siv Svi Svii Sviii S1 S2 S3 S6 S10 S14 S16 S19 S21 S23 S27 S30 S33 S38 S41 S44 S44 S46 S48 S50 S52 S53 S57 S59 S59 S60 S61 S62 S66 S66 S68 S71 S71 S73 S75 S77 S80 S84 S86 S89 S93 S97 S102 Disclaimer Work Group Membership KDIGO Board Members Abbreviations and Acronyms Reference Keys Abstract Foreword Guideline Scope and Intended Users Chapter 1: Induction Therapy Chapter 2: Initial Maintenance Immunosuppressive Medications Chapter 3: Long-Term Maintenance Immunosuppressive Medications Chapter 4: Strategies to Reduce Drug Costs Chapter 5: Monitoring Immunosuppressive Medications Chapter 6: Treatment of Acute Rejection Chapter 7: Treatment of Chronic Allograft Injury Chapter 8: Monitoring Kidney Allograft Function Chapter 9: Kidney Allograft Biopsy Chapter 10: Recurrent Kidney Disease Chapter 11: Preventing, Detecting, and Treating Nonadherence Chapter 12: Vaccination Chapter 13: Viral Diseases 13.1: BK Polyoma Virus 13.2: Cytomegalovirus 13.3: Epstein-Barr Virus and Post-Transplant Lymphoproliferative Disease 13.4: Herpes Simplex Virus 1, 2 and Varicella Zoster Virus 13.5: Hepatitis C Virus 13.6: Hepatitis B Virus 13.7: Human Immunodeficiency Virus Chapter 14: Other Infections 14.1: Urinary Tract Infection 14.2: Pneumocystis Jirovecii Pneumonia 14.3: Tuberculosis 14.4: Candida Prophylaxis Chapter 15: Diabetes Mellitus 15.1: Screening for New-Onset Diabetes after Transplantation 15.2: Managing NODAT or Diabetes Present at Transplantation Chapter 16: Hypertension, Dyslipidemias, Tobacco Use, and Obesity 16.1: Hypertension 16.2: Dyslipidemias 16.3: Tobacco Use 16.4: Obesity Chapter 17: Cardiovascular Disease Management Chapter 18: Cancer of the Skin and Lip Chapter 19: Non Skin Malignancies Chapter 20: Managing Cancer with Reduction of Immunosuppressive Medication Chapter 21: Transplant Bone Disease Chapter 22: Hematological Complications Chapter 23: Hyperuricemia and Gout

3 S104 S106 S106 S107 S108 S110 S111 S112 S125 S129 S131 Chapter 24: Growth and Development Chapter 25: Sexual Function and Fertility 25.1: Sexual Function 25.2: Female Fertility 25.3: Male Fertility Chapter 26: Lifestyle Chapter 27: Mental Health Appendix: Methods for Guideline Development Biographic and Disclosure Information Acknowledgments References

4 TABLES S9 S15 S17 S28 S28 S29 S31 S34 S38 S39 S39 S42 S42 S45 S50 S56 S61 S64 S66 S67 S69 S72 S72 S73 S76 S77 S77 S79 S82 S90 S98 S114 S118 S119 S119 S120 S122 S122 S123 S123 S124 Table 1. Risk of acute rejection in multivariate analyses Table 2. Toxicity profiles of immunosuppressive medications Table 3. CNI cost reduction from the concomitant use of ketoconazole Table 4. Routine screening after kidney transplantation Table 5. Some causes of proteinuria after kidney transplantation Table 6. Definitions of proteinuria and albuminuria Table 7. Diagnostic criteria for acute kidney injury Table 8. Screening for recurrent diseases Table 9. Assessment of medication adherence Table 10. Risk factors for medication nonadherence Table 11. A summary of interventions aimed at improving medication adherence Table 12. Recommended vaccines after kidney transplantation Table 13. Contraindicated vaccinations after transplantation Table 14. Treatment of BKV nephropathy by modification of maintenance immunosuppression Table 15. Categories of PTLD Table 16. Outcomes of clinical trials of lamivudine therapy Table 17. Antimicrobial agents for the prevention of PCP in KTRs Table 18. Independent predictors of CVD in KTRs Table 19. Criteria for the diagnosis of diabetes Table 20. Risk factors for NODAT Table 21. Pharmacological management of diabetes in KTRs Table 22. Guideline definitions of hypertension Table 23. Adult blood pressure thresholds for defining hypertension Table 24. Advantages and disadvantages of major antihypertensive agent classes in KTRs Table 25. Pharmacological therapies for cigarette smoking cessation in KTRs Table 26. Definition and classification of obesity in adults Table 27. Definition and classification of obesity for children and adolescents 6 years of age and older Table 28. National Heart Lung Blood Institute weight-loss treatment guidelines Table 29. Cancers categorized by SIR for kidney transplant patients and cancer incidence Table 30. Viral-associated cancers Table 31. Medications associated with hematologic abnormalities Table 32. Systematic review topics and screening criteria Table 33. Literature search yield of RCTs Table 34. Hierarchy of outcomes Table 35. Classification of study quality Table 36. Example of an evidence profile Table 37. GRADE system for grading quality of evidence Table 38. Final grade for overall quality of evidence Table 39. Balance of benefits and harm Table 40. KDIGO nomenclature and description for grading recommendations Table 41. Determinants of strength of recommendations Additional information in the form of Supporting tables can be found online at American Journal of Transplantation 2009; 9 (Suppl 3): Si Si Si

5 FIGURES S56 S118 Figure 1. HBeAg clearance vs. lamivudine duration. Figure 2. Literature search diagram for systematically reviewed RCTs. Sii American Journal of Transplantation 2009; 9 (Suppl 3): Sii Sii

6 Disclaimer SECTION I: USE OF THE CLINICAL PRACTICE GUIDELINE This Clinical Practice Guideline document is based upon the best information available as of March It is designed to provide information and assist decisionmaking. It is not intended to define a standard of care, and should not be construed as one, nor should it be interpreted as prescribing an exclusive course of management. Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every health-care professional making use of these recommendations is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation. The recommendations for research contained within this document are general and do not imply a specific protocol. SECTION II: DISCLOSURE Kidney Disease: Improving Global Outcomes (KDIGO) makes every effort to avoid any actual or reasonably perceived conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the Work Group. All members of the Work Group are required to complete, sign, and submit a disclosure and attestation form showing all such relationships that might be perceived or actual conflicts of interest. This document is updated annually and information is adjusted accordingly. All reported information is published in its entirety at the end of this document in the Work Group members Biographic and Disclosure Information section, and is on file at the National Kidney Foundation (NKF), Managing Agent for KDIGO. KDIGO gratefully acknowledges the following sponsors that make our initiatives possible: Abbott, Amgen, Belo Foundation, Coca-Cola Company, Dole Food Company, Genzyme, Hoffmann-LaRoche, JC Penney, NATCO-The Organization for Transplant Professionals, National Kidney Foundation-Board of Directors, Novartis, Robert and Jane Cizik Foundation, Shire, Transwestern Commercial Services, and Wyeth. KDIGO is supported by a consortium of sponsors and no funding is accepted for the development of specific guidelines. American Journal of Transplantation 2009; 9 (Suppl 3): Siii Siii Siii

7 Work Group Membership Work Group Co-Chairs Bertram L. Kasiske, MD Hennepin County Medical Center Minneapolis, MN Martin G. Zeier, MD, FASN University Hospital of Heidelberg Heidelberg, Germany Work Group Jonathan C. Craig, MBChB, MM (Clin Epi), DCH, FRACP, PhD The Children's Hospital at Westmead Westmead, Australia Henrik Ekberg, MD, PhD Lund University Malmö, Sweden Catherine A. Garvey, RN, BA, CCTC University of Minnesota Minneapolis MN Michael D. Green, MD, MPH Children s Hospital of Pittsburgh Pittsburgh, PA Vivekanand Jha, MD, FRCP Postgraduate Medical Institute Chandigarh, India Michelle A. Josephson, MD University of Chicago Chicago, IL Bryce A. Kiberd, MD Dalhousie University Halifax, Canada Henri A. Kreis, MD Université Paris Descartes & Hôpital Necker Paris, France Ruth A. McDonald, MD University of Washington Seattle Children s Hospital Seattle, WA John M. Newmann, PhD, MPH Health Policy Research & Analysis Reston, VA Gregorio T. Obrador, MD, MPH Universidad Panamericana School of Medicine Mexico City, Mexico Liaison to The Transplantation Society and the Global Alliance of Transplantation: Jeremy R. Chapman, MD, FRACP, FRCP Westmead Hospital Westmead, Australia Liaison to the American Society of Transplantation Flavio G. Vincenti, MD University of California at San Francisco San Francisco, CA Evidence Review Team Tufts Center for Kidney Disease Guideline Development and Implementation, Tufts Medical Center, Boston, MA, USA: Ethan M. Balk, MD, MPH, Project Director and Director, Evidence-based Medicine Martin Wagner, MD, MS, Assistant Project Director Gowri Raman, MD, Research Fellow Samuel Abariga, MD, MS, Research Associate Amy Earley, BS, Project Coordinator In addition, support and supervision were provided by: Katrin Uhlig, MD, MS, Director, Guideline Development Joseph Lau, MD, Methods Consultant Siv American Journal of Transplantation 2009; 9 (Suppl 3): Siv Siv

8 Work Group Member Expertise and Disclosure Information Work Group Member Area of Expertise Disclosures Bertram L. Kasiske, MD Work Group Co-Chair; USA Martin G. Zeier, MD, FASN Work Group Co-Chair; Germany Jeremy R. Chapman, MD, FRACP, FRCP Australia Jonathan C. Craig, MBChB, MM (Clin Epi), DCH, FRACP, PhD Australia Henrik Ekberg, MD, PhD Sweden Catherine A. Garvey, RN, BA, CCTC USA Michael D. Green, MD, MPH USA Vivekanand Jha, MD, FRCP India Michelle A. Josephson, MD USA Bryce A. Kiberd, MD Canada Henri A. Kreis, MD France Ruth A. McDonald, MD USA John M. Newmann, PhD, MPH USA Gregorio T. Obrador, MD, MPH Mexico Flavio G. Vincenti, MD USA ; Liaison for The Transplantation Society and the Global Alliance for Transplantation Pediatrician, Transplant Surgeon Transplant Coordinator Pediatrician, Transplant Infectious Disease Specialist Pediatrician, Transplant Recipient ; Liaison for the American Society of Transplantation Advisor/Consultant: Astellas; LithoLink; Novartis; Wyeth Grant/Research Support: Bristol-Myers Squibb; Genzyme; Merck-Schering Plough Grant/Research Support: Astellas; Novartis; Parexel Advisor/Consultant: Astellas; Hoffmann-LaRoche; Novartis; Wyeth Grant/Research Support: Bristol-Myers Squibb; Novartis; Wyeth No relevant financial relationships reported. Advisor/Consultant: Astellas; Bristol-Myers Squibb; Hansa Medical; Hoffmann-LaRoche; Life Cycle Pharma; Novartis; Wyeth Speaker: Astellas; Hoffmann-LaRoche No relevant financial relationships reported. No relevant financial relationships reported. No relevant financial relationships reported. Advisor/Consultant: Digitas Health; MKSAP; Wyeth Speaker: Hoffmann-LaRoche Grant/Research Support: Amgen; Astellas; Wyeth Speaker: Hoffmann-LaRoche Advisor/Consultant: Novimmune No relevant financial relationships reported. Advisor/Consultant: Arbor Research Collaborative; Renaissance Health Care No relevant financial relationships reported. Grant/Research Support: Astellas; Bristol-Myers Squibb; Genentech; Hoffmann-LaRoche; Novartis; Wyeth American Journal of Transplantation 2009; 9 (Suppl 3): Sv Sv Sv

9 KDIGO Board Members Garabed Eknoyan, MD Norbert Lameire, MD Founding KDIGO Co-Chairs Kai-Uwe Eckardt, MD KDIGO Co-Chair Bertram L. Kasiske, MD KDIGO Co-Chair Omar I. Abboud, MD, FRCP Sharon Adler, MD, FASN Sharon P. Andreoli, MD Robert Atkins, MD Mohamed Benghanem Gharbi, MD, PhD Gavin J. Becker, MD, FRACP Fred Brown, MBA, FACHE Jerilynn D. Burrowes, PhD, RD Evelyn Butera, MS, RN, CNN Daniel Cattran, MD, FRCPC Allan J. Collins, MD, FACP Ricardo Correa-Rotter, MD William G. Couser, MD Olivier Coustere Adrian Covic, MD, PhD Jonathan C. Craig, MBChB, MM (Clin Epi), DCH, FRACP, PhD Angel de Francisco, MD Paul de Jong, MD Tilman B. Drüeke, MD, FRCP Denis P. Fouque, MD, PhD Gordon Guyatt, MD, MSc, BSc, FRCPC Philip Halloran, MD, PhD David Harris, MD Michel Jadoul, MD Vivekanand Jha, MD, FRCP Martin K. Kuhlmann, MD Suhnggwon Kim, MD, PhD Adeera Levin, MD, FRCPC Nathan W. Levin, MD, FACP Philip K.T. Li, MD, FRCP, FACP Zhi-Hong Liu, MD Francesco Locatelli, MD Alison M. MacLeod, MBChB, MD, FRCP Pablo Massari, MD Peter A. McCullough, MD, MPH, FACC, FACP, FCCP, FAHA Rafique Moosa, MD Miguel C. Riella, MD Bernardo Rodriquez-Iturbe, MD Robert Schrier, MD Trent Tipple, MD Yusuke Tsukamoto, MD Raymond Vanholder, MD Giancarlo Viberti, MD, FRCP Theodor Vogels, MSW David Wheeler, MD, FRCP Carmine Zoccali, MD KDIGO Guideline Development Staff Kerry Willis, PhD, Senior Vice-President for Scientific Activities Donna Fingerhut, Managing Director of Scientific Activities Michael Cheung, Guideline Development Director Dekeya Slaughter-Larkem, Guideline Development Project Manager Sean Slifer, Scientific Activities Manager Svi American Journal of Transplantation 2009; 9 (Suppl 3): Svi Svi

10 Abbreviations and Acronyms ACCORD ACE-I ADA ADVANCE AGREE ALG ALT ANCA ARB ATG AUC BCG BKV BMD BMI CAD CAI CAN CCB CDC CHF CI CKD CKD-MBD CMV CNI COGS CsA CsA-ME CSF CVD CYP3A4 D DGF EBV EC-MPS egfr ELISA ERT ESA FDA FOBT FSGS GBM GFR HbA 1c HBcAb HBeAg Action to Control Cardiovascular Risk in Diabetes Angiotensin-converting enzyme inhibitor American Diabetes Association Action in Diabetes and Vascular Disease Appraisal of Guidelines for Research and Evaluation Antilymphocyte globulin Alanine aminotransferase Antineutrophil cytoplasmic antibody Angiotensin II receptor blocker Antithymocyte globulin Area under concentration-time curve Bacillus Calmette-Guérin BK polyoma virus Bone mineral density Body mass index Coronary artery disease Chronic allograft injury Chronic allograft nephropathy Calcium-channel blocker US Centers for Disease Control and Prevention Congestive heart failure Confidence Interval Chronic kidney disease Chronic kidney disease mineral and bone disorder Cytomegalovirus Calcineurin inhibitor Conference on Guideline Standardization Cyclosporine A Cyclosporine A microemulsion Colony-stimulating factor Cardiovascular disease Cytochrome P450 3A4 Transplant donor Delayed graft function Epstein-Barr virus Enteric-coated mycophenolate sodium Estimated glomerular filtration rate Enzyme-linked immunosorbent assay Evidence Review Team Erythropoiesis-stimulating agent Food and Drug Administration Fecal occult blood testing Focal segmental glomerulosclerosis Glomerular basement membrane Glomerular filtration rate Hemoglobin A 1c Antibody to hepatitis B core antigen Hepatitis B E antigen HBsAb Antibody to hepatitis B surface antigen HBsAg Hepatitis B surface antigen HBV Hepatitis B Virus HCV Hepatitis C Virus HDL-C High-density lipoprotein cholesterol HIV Human immunodeficiency virus HLA Human leukocyte antigen HPV Human papillomavirus HSV Herpes simplex virus HUS Hemolytic-uremic syndrome IgA Immunoglobulin A IgG Immunoglobulin G IL2 Interleukin 2 IL2-RA Interleukin-2 receptor antagonist IF/TA Interstitial fibrosis and tubular atrophy KDIGO Kidney Disease: Improving Global Outcomes KDOQI Kidney Disease Outcomes Quality Initiative KTR Kidney transplant recipient LDL-C Low-density lipoprotein cholesterol MMF Mycophenolate mofetil MPA Mycophenolic acid MPGN Membranoproliferative glomerulonephritis mtori Mammalian target of rapamycin inhibitor(s) NAT Nucleic acid testing NIH National Institutes of Health NKF National Kidney Foundation NODAT New-onset diabetes after transplantation OKT3 Muromonab (anti T-cell antibody) PTH Parathyroid hormone PCP Pneumocystis jirovecii pneumonia PPD Purified protein derivative PRA Panel-reactive antibody PSA Prostate-specific antigen PTLD Post-transplant lymphoproliferative disease PVD Peripheral vascular disease R Transplant recipient RCT Randomized controlled trial RR Relative risk rhgh Recombinant human growth hormone SIR Standardized incidence ratio TB Tuberculosis UKPDS United Kingdom Prospective Diabetes Study USPSTF US Preventive Services Task Force UTI Urinary tract infection VZV Varicella zoster virus WHO World Health Organization American Journal of Transplantation 2009; 9 (Suppl 3): Svii Svii Svii

11 Reference Keys NOMENCLATURE AND DESCRIPTION FOR RATING GUIDELINE RECOMMENDATIONS Within each recommendation, the strength of recommendation is indicated as Level 1, Level 2, or Not Graded, and the quality of the supporting evidence is shown as A, B, C, or D. Grade* Implications Patients Clinicians Policy Level 1 We recommend Most people in your situation would want the recommended course of action and only a small proportion would not. Most patients should receive the recommended course of action. The recommendation can be adopted as a policy in most situations. Level 2 We suggest The majority of people in your situation would want the recommended course of action, but many would not. Different choices will be appropriate for different patients. Each patient needs help to arrive at a management decision consistent with her or his values and preferences. The recommendation is likely to require debate and involvement of stakeholders before policy can be determined. * The additional category Not Graded was used, typically, to provide guidance based on common sense or where the topic does not allow adequate application of evidence. The most common examples include recommendations regarding monitoring intervals, counseling, and referral to other clinical specialists. The ungraded recommendations are generally written as simple declarative statements, but are not meant to be interpreted as being stronger recommendations than Level 1 or 2 recommendations. A: High quality of evidence. We are confident that the true effect lies close to that of the estimate of the effect. B: Moderate quality of evidence. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. C: Low quality of evidence. The true effect may be substantially different from the estimate of the effect. D: Very low quality of evidence. The estimate of effect is very uncertain, and often will be far from the truth. Sviii American Journal of Transplantation 2009; 9 (Suppl 3): Sviii Sviii

12 Conversion Factors of Metric Units to SI Units Parameter Metric Units Conversion Factor SI Units Albumin g/dl 10 g/l Calcium mg/dl mmol/l Cholesterol mg/dl mmol/l Creatinine mg/dl 88.4 µmol/l Creatinine clearance ml/min ml/s Glucose mg/dl mmol/l Hemoglobin g/dl 10 g/l High-density lipoprotein cholesterol (HDL-C) mg/dl mmol/l Insulin µu/ml pmol/l Low-density lipoprotein cholesterol (LDL-C) mg/dl mmol/l Neutrophil count #/µl 1 x 10 6 #/L Parathyroid hormone pg/ml 1 ng/l Phosphate (as inorganic phosphorus) mg/dl mmol/l Platelet count #/µl 1 x 10 6 #/L Protein, total g/dl 10 g/l Titers copies/ml 1000 copies/l Triglycerides mg/dl mmol/l Uric acid mg/dl µmol/l Urinary oxalate excretion mg/dl µmol/d Urinary protein excretion g/dl 1000 mg/dl Vitamin D, 25-Hydroxyvitamin D ng/ml nmol/l Note: Metric unit x conversion factor = SI unit. American Journal of Transplantation 2009; 9 (Suppl 3): Six Six Six

13 American Journal of Transplantation 2009; 9 (Suppl 3): S1 S157 Wiley Periodicals Inc The Authors Journal compilation 2009 The American Society of Transplantation and the American Society of Transplant Surgeons doi: /j x Abstract The 2009 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline on the monitoring, management, and treatment of kidney transplant recipients is intended to assist the practitioner caring for adults and children after kidney transplantation. The guideline development process followed an evidencebased approach, and management recommendations are based on systematic reviews of relevant treatment trials. Critical appraisal of the quality of the evidence and the strength of recommendations followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. The guideline makes recommendations for immunosuppression, graft monitoring, as well as prevention and treatment of infection, cardiovascular disease, malignancy, and other complications that are common in kidney transplant recipients, including hematological and bone disorders. Limitations of the evidence, especially on the lack of definitive clinical outcome trials, are discussed and suggestions are provided for future research. Keywords: Guideline; KDIGO; kidney transplant recipient care; immunosuppression; graft monitoring; infectious diseases; cardiovascular disease; malignancy; mineral and bone disorder; hematological complications; hyperuricemia; gout; growth; sexual function; fertility; mental health In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. American Journal of Transplantation 2009; 9(Suppl 3): S1 S157. S1

14 Foreward Since the first successful kidney transplantation in 1954, there has been an exponential growth in publications dealing with the care of kidney transplant recipients (KTRs). In addition, the science of conducting and interpreting both clinical trials and observational studies has become increasingly controversial and complex. Caring for KTRs requires specialized knowledge in areas as varied as immunology, pharmacology, nephrology, endocrinology and infectious disease. The last two comprehensive clinical practice guidelines on the care of KTRs were published in 2000 by the American Society of Transplantation and the European Best Practices Guidelines Expert Group. Both of these guidelines were based primarily on expert opinion, not rigorous evidence review. For these reasons, the international consortium of kidney guideline developers, Kidney Disease: Improving Global Outcomes (KDIGO), concluded that a new comprehensive evidence-based clinical practice guideline for the care of KTRs was necessary. It is our hope that this document will serve several useful purposes. Our primary goal is to improve patient care. We hope to accomplish this in the short term by helping clinicians know and better understand the evidence (or lack of evidence) that determines current practice. By making this guideline broadly applicable, our purpose is to also encourage and enable the establishment and development of transplant programs worldwide. Finally, by providing comprehensive evidence-based recommendations, this guideline will also help define areas where evidence is lacking and research is needed. Helping to define a research agenda is an often neglected, but very important function of clinical practice guideline development. We used the GRADE system to rate the strength of evidence and the strength of recommendations. In all, there were only 4 (2%) recommendations in this guideline for which the overall quality of evidence was graded A, whereas 27 (13.6%) were graded B, 77 (38.9%) were graded C, and 90 (45.5%) were graded D. Although there are reasons other than quality of evidence to make a grade 1 or 2 recommendation, in general, there is a correlation between the quality of overall evidence and the strength of the recommendation. Thus, there were 50 (25.3%) recommendations graded 1 and 148 (74.7%) graded 2. There were 3 (1.5%) recommendations graded 1A, 16 (8.1%) were 1B, 18 (9.1%) were 1C, and 13 (6.6%) were 1D. There was 1 (0.5%) graded 2A, 11 (5.6%) were 2B, 59 (29.8%) were 2C, and 77 (38.9%) were 2D. There were 45 (18.5%) statements that were not graded. Some argue that recommendations should not be made when evidence is weak. However, clinicians still need to make clinical decisions in their daily practice, and they often ask what do the experts do in this setting? We opted to give guidance, rather than remain silent. These recommendations were often rated with a low strength of recommendation and a low strength of evidence, or were not graded. It is important for the users of this guideline to be cognizant of this (see Disclaimer). In every case these recommendations are meant to be a place for clinicians to start, not stop, their inquiries into specific management questions pertinent to the patients they see in daily practice. We wish to thank Martin Zeier, Co-Chair, along with all of the Work Group members who volunteered countless hours of their time developing this guideline. We also thank the Evidence Review Team members and staff of the National Kidney Foundation who made this project possible. Finally, we owe a special debt of gratitude to the many KDIGO Board members and individuals who volunteered time reviewing the guideline, and making very helpful suggestions. Kai-Uwe Eckardt, MD KDIGO Co-Chair Bertram L. Kasiske, MD KDIGO Co-Chair S2 American Journal of Transplantation 2009; 9 (Suppl 3): S2 S2

15 Guideline Scope and Intended Users This guideline describes the prevention and treatment of complications that occur after kidney transplantation. We do not include pretransplant care. Specifically, we do not address issues pertinent to the evaluation and management of candidates for transplantation, or the evaluation and selection of kidney donors. Although many of the issues that are pertinent to KTRs are also pertinent to recipients of other organ transplants, we intend this guideline to be for KTRs only. We cover only those aspects of care likely to be different for KTRs than for patients in the general population. For example, we deal with the diagnosis and treatment of acute rejection, but not with the diagnosis and treatment of community-acquired pneumonia. We also make recommendations pertinent to the management of immunosuppressive medications and their complications, including infections, malignancies, and cardiovascular disease (CVD). This guideline ends before the kidney fails, either by death of the recipient with a functioning graft, return to dialysis, or retransplantation. We do not deal with the preparation of KTRs for return to dialysis or retransplantation. This guideline was written for doctors, nurses, coordinators, pharmacists, and other medical professionals who directly or indirectly care for KTRs. It was not developed for administrative or regulatory personnel per se. For example, no attempts were made to develop clinical performance measures. Similarly, this guideline was not written for patients directly, although carefully crafted explanations of guideline recommendations could potentially provide useful information for patients. This guideline was written for transplant-care providers throughout the world. As such, it addresses issues that are important to the care of KTRs in both developed and developing countries, but nowhere was the quality of care compromised for utilitarian purposes. Nevertheless, we recognize that, in many parts of the world, treatment of end-stage kidney disease (chronic kidney disease [CKD] stage 5) with dialysis is not feasible, and transplantation can only be offered as a life-saving therapy if it is practical and cost-effective. Therefore, in providing a comprehensive, evidence-based guideline for the care of the KTRs, we were cognizant of the fact that programs in some areas of the world may need to adopt cost-saving measures in order to make transplantation possible. American Journal of Transplantation 2009; 9 (Suppl 3): S3 S3 S3