Supplemental Appendix 2: Concurrence with Institute of Medicine standards for systematic reviews and for guidelines. Supplementary material is linked to the online version of the paper at http://www.kdigo.org/home/guidelines/lipids methods for guideline development Biographic and disclosure information Marcello A Tonelli, MD, SM, FRCPC (Work Group Co-Chair), received an MD from the University of Western Ontario, specialist certification in nephrology (FRCPC) at Dalhousie University, and an SM in epidemio- logy from Harvard University. He is a nephrologist and Associate Professor at the University of Alberta. He serves as Associate Editor of American Journal of Kidney Diseases, the Cochrane Renal Group and the Journal of Nephrology, and is a member of the Editorial Board for Journal of the American Society of Nephrology. Dr. Tonelli is the President of the Canadian Society of Nephrology, a Councillor of the International Society of Nephrology and a past member of the Minister s Expert Committee for Drug Evaluation for the Province of Alberta. In March 2010, Dr. Tonelli was named the chair of the Canadian Task Force for Preventive Health Care, a national panel of experts that will make recommen- dations about preventive health services to Canada s more than 36,000 family physicians. Dr. Tonelli holds a Health Scholar award from the Alberta Heritage Foundation for Medical Research (AHFMR) and a Canada Research Chair in the optimal care of people with CKD. He is a founding member of the Alberta Kidney Disease Network and co-leader of the AHFMR Interdisciplinary Chronic Disease Collaboration (ICDC) research team. Since 2005, Dr. Tonelli has been the co-leader of a joint initiative between the University of Alberta and the Hospital Civil de Guadalajara, aimed at prevention of kidney failure among the poor of Jalisco, Mexico. Consultant: Merck (honorarium donated to charity) Speaker: Merck (honorarium donated to charity) Christoph Wanner, MD (Work Group Co-Chair), is Head of Nephrology, Department of Medicine at University of Wu rzburg, where he also obtained his MD. He then trained in Internal Medi- cine and subsequently Nephrology, in Freiburg, Germany. Dr Wanner has maintained an active research interest in the role of lipids in progression of kidney disease, having participated in two major trials conducted in this area: 4D and SHARP. His research also includes the elucidation of the inflammatory response syndrome in diabetic nephropathy, CKD and ESRD; pathogenesis and treatment for Fabry disease; and identification of risk factors for CKD progression and CVD in large study cohorts. Dr. Wanner has authored over 400 publications, including serving presently as Editor-in-Chief of Journal of Renal Nutrition and editorial board member for Clinical Nephrology, Current Opinion in Nephrology & Hyper- tension, Kidney International, and Nephrology Dialysis Trans- plantation. He is also President of the International Society of Renal Nutrition and Metabolism and Chairman of ERA-EDTA Renal Registry. In recognition of his contributions to nephrology, he was awarded the International Distinguished Medal from the US NKF in 2007 and nominated as honorary member of the Polish Society of Nephrology in 2011. In 2012 he obtained a doctor honoris causa from the Charles University of Prague. Advisory Board: Boehringer Ingelheim; Keryx; Reata Consultant: AMAG; Baxter; Boehringer Ingelheim; Reata Development of Educational Materials: Mitsubishi Grant/Research Support: Genzyme* Speaker: Abbott; Amgen; Astellas; AstraZeneca; Bristol- Myers Squibb; Fresenius Medical Care; Genzyme; Merck Sharp & Dohme; Mitsubishi; Roche *monies paid to institution Alan Cass, MBBS, FRACP, PhD, is Director of the Menzies School of Health Research in Darwin, Australia and previously served as Senior Director, Renal and Metabolic Division, The George Institute for Global Health in Sydney, Australia. Dr Cass completed his nephrology training and PhD studies at the University of Sydney where he investigated the social determinants of ESRD. His current research encompasses the use of rigorous quantitative and qualitative methods to foster the development, implementation and evaluation of strate- gies to address the growing burden of CKD. He also conducts primary care intervention research aiming to reduce barriers to necessary care for Indigenous Australians and enhance access to renal services in remote areas, thereby improving their health outcomes. Dr Cass is President-Elect for the Australian and New Zealand Society of Nephrology (ANZSN), a member of the Executive of the Australasian Kidney Trials Network and International Society of Nephrol- http://www.kidney-international.org biographic and disclosure information & 2013 KDIGO ogy (ISN) CKD Policy Task Force. An author of over 150 publications, he recently received the 2012 NSW Aboriginal Health Award for Closing the Gap through Excellence in Chronic Care, and the 2013 T J Neale Award for Outstanding Contribution to Nephrological Science from ANZSN. Advisory Board: Abbott; Merck Consultant: Baxter Expert Testimony: Merck Grant/Research Support: Amgen;* Baxter;* Merck;* Novartis* Speaker: Fresenius Medical Care *monies paid to institution Amit X Garg, MD, FRCPC, FACP, PhD, is a Professor of Medicine, Epidemiology and Biostatistics at the University of Western Ontario. He practices nephro- logy at the London Health Sciences Centre and cares for patients with CKD, acute kidney injury (AKI) and individuals wishing to donate a kidney to a loved one. Dr. Garg conducts clinical and health services research to improve health outcomes for patients with kidney diseases including those receiving dialysis or a kidney transplant. He also aims to improve the efficiency by which renal care is delivered. He currently holds a Clinician Scientist Award from the Canadian Institutes of Health Research. He is the current Director of the London Kidney Clinical Research Unit and Scientific Director of the Institute for Clinical Evaluative Sciences at Western Facility. Dr Garg reported no relevant financial relationships Hallvard Holdaas, MD, PhD, is senior consultant in Nephrology at Department of Transplant Medicine, Oslo University Hospital, Rikshospitalet, Norway, where he also received his training in transplant medicine. His primary research interests are immunosuppression, dyslipidemia, and CVD in renal transplant recipients. He was the PI in the ALERT trial (fluvastatin) and co-PI in the AURORA and SHARP trials. Dr Holdaas is a member of numerous professional organizations including American Society of Nephrology, American Society of Transplantation, European Dialysis and Transplant Associa- tion and European Society for Organ Transplantation. He has published more than 170 original articles, reviews and book chapters in the fields of nephrology, dialysis and transplantation. Speaker: Abbott; Astellas; AstraZeneca; Novartis Alan G Jardine, MBChB, MD, FRCP, graduated in Physiology (1981) and Medicine (1984) from the University of Glasgow. He undertook postgraduate research training as a Clinical Training Fellow in the MRC Blood Pressure Unit, where he pursued studies on the phy- siology, pharmacology and therapeutic potential of natriuretic peptides. He trained initially in Endocrinology and subsequently Nephrology, in Glasgow and Aberdeen, UK. Since 1994 he has been on the staff of the University of Glasgow, where he has been Professor of Renal Medicine since 2006. He has pursued a variety of research themes that center on accelerated vascular disease and long- term adverse outcomes in patients with renal disease and transplantation, their pathophysiological and genetic deter- minants, and their management. His current research combines laboratory work, clinical research and clinical trials, and he is the leader of the Renal Research Group in the BHF Glasgow Cardiovascular Research Centre. Since 2010 he has been the Head of the Undergraduate Medical School in Glasgow. He is a member of the Council of the European Society for Transplantation. Consultant: Abbott; Novartis; Pfizer;* Opsona* Development of Educational Materials: Pfizer* Expert Testimony: Commission on Human Medicines (UK); European Medicines Agency; US Food and Drug Adminis- tration Speaker: Astellas; Bristol-Myers Squibb; Genzyme (Sanofi); Merck Sharp & Dohme; Pfizer* *monies paid to institution Lixin Jiang, MD, PhD, is the Director for National Cardiovascular Bio-bank Centre, Co-Director for China Oxford Centre for International Health Research, and Deputy Director for Center of Dyslipidemia and Cardiovascular Disease of Fuwai Hospital. She is also Editor-in-Chief for The Lancet Chinese Edition, Editorial Board Member for the journal Circulation: Cardiovascular Quality and Out- comes and a Doctoral mentor at Chinese Academy of Medical Sciences and Peking Union Medical College. Dr. Jiang obtained her medical degree from the Chinese Academy of Medical Sciences and Peking Union Medical College. Her main research interests involve large RCTs, epidemiological studies, pharmacogenomics studies and outcomes research. She serves as the Executive Member in the Young and Middle-Aged Scholar Committee of Stroke Screening and Prevention, National Health and Family Planning Commission of China, and the Advisory Expert on the Panel on Cardiovascular Disease, Committee of Experts on Rational Drug Use, National Health and Family Planning Commission of China. biographic and disclosure information As the Steering Committee member and site PI in China, Dr. Jiang has successfully run several international large- scale clinical trials including: ISCHEMIA, HPS3/TIMI55: TRACER, and INTER-HEART. Moreover, she is the PI of four national key research projects funded by Chinese government, including China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) (2012 2014), The Study on Hereditary Susceptibility to Statin-related Myopathy (2011 2015), Establishment of the Bio-bank of Chinese Cardiovascular & Cerebro- vascular Disease (2011 2015), and China PEACE-stent (2013 2014). Dr. Jiang started her international collaboration with the Oxford University in the 1980 s and since then she has been cooperating with different top research institu- tions worldwide. Presently, her collaborative partners include Oxford University, Yale University, NHLBI, NIH, University of Edinburgh, Duke University, Merck Research Laboratories, etc. Through years of research operation, Dr. Jiang has set up a reliable and stable national coopera- tion network of over 200 hospitals within 31 provinces in China. Her achievements in the field of evidence-based medicine have attracted international recognition and acclaim. Sir Richard Peto, Co-Director of Clinical Trials Service Unit and Epidemiological Studies Unit at Oxford University, once said that she has been a whirlwind force for evidence and The Lancet commented that she is at the heart of China s evidence base. Dr Jiang reported no relevant financial relationships Florian Kronenberg, MD, received his MD from the University of Innsbruck, Austria. After specializing in Medical Genetics he worked two years each at the University of Utah, Salt Lake City, USA and the Institute of Epidemiology at the Helmholtz Center, Munich, Germany. In 2004, he became Full Professor for Genetic Epidemiology at the Innsbruck Medical University where he presently heads the Department of Medical Genetics, Molecular and Clinical Pharmacology. Dr. Kronenberg served as PI in several studies on genetic risk factors for atherosclerosis and biomarkers for the progression of CKD including the Mild to Moderate Kidney Disease Study00 (MMKD). He served as a workgroup member of the NKF K/DOQI Guidelines on Cardiovascular Disease in Dialysis Patients and is Associate Editor of Atherosclerosis and Academic Editor of PLoS One. Advisory Board: Genzyme, Keryx Speaker: Amgen; Genzyme Rulan S Parekh, MD, MS, FRCP(C), FASN, is a Clinician Scientist and Associate Professor of Medicine and Paediatrics at the University of Toronto, The Hospital for Sick Children and University Health Net- work. The focus of Dr. Parekh s research is to study risk factors both clinically and genetically leading to progression of CKD and CVD. She has published over 80 peer reviewed manuscripts and book chapters, and has mentored over 25 postdoctoral fellows and students. She leads the NIH-NIDDK sponsored Predictors in Arrhythmic and Cardiovascular Disease in End Stage Renal Disease (PACE) , a new cohort study in dialysis patients to identify risk factors for sudden cardiac death. She is currently the chair of the American Kidney Fund Clinical Scientist Committee and on the Board of Trustees of the American Kidney Fund. She has recently been inducted into the American Society of Clinical Investigation and Society for Pediatric Research and has received awards for Advising, Teaching and Mentoring Award from the Johns Hopkins Bloomberg School of Public Health. She is presently an Associate Editor for BMC Nephrology and on the editorial board of the Clinical Journal of the American Society of Nephrology. Trustee: American Kidney Fund (no compensation) Grant/Research Support: Physician Services Inc* *monies paid to institution Tetsuo Shoji, MD, PhD, is affiliated with the Department of Geriatrics and Vascular Medicine, Osaka City Univer- sity Graduate School of Medicine, Osaka, Japan. He studied medicine in the medical school of Osaka City University and then worked at the Second Department of Internal Medicine, Osaka City University Hospital. He is interested in dyslipidemia, and other metabolic and endocrine alterations as factors affecting CVD in patients with CKD. He is a member of the Japanese Society for Dialysis Therapy (JSDT), the Japanese Society of Nephrology (JSN), the Japan Atherosclerosis Society (JAS), the Japan Diabetes Society (JDS) and others. He was the recipient of the Society Award from JSDT and a Work Group Member for the following guideline groups: 2011 JSDT Guidelines for the Evaluation and Treatment of Cardiovascular Complications in HD Patients; 2012 JSDT Guideline for CKD-Mineral Bone Disorder; 2012 JAS Guidelines for Prevention of Atherosclerotic CVD; and 2013 JSN Guideline for the Treatment of CKD. Grant/Research Support: Astellas;* Daiichi Sankyo;* Dainippon Sumitomo;* Mochida;* Shionogi* Speaker: Astellas; Daiichi Sankyo; Kowa; Kyowa Hakko Kirin; Merck Sharp & Dohme; Mochida; Pfizer; Shionogi *monies paid to institution biographic and disclosure information Robert J Walker, MBChB, MD (Otago), FRACP, FASN, FAHA, is Professor of Medicine and Head of the Department of Medicine at Dunedin School of Medicine, University of Otago, New Zealand. He is also a Consultant Nephrologist and Head of Nephrology at Healthcare Otago. Dr Walker has a broad base of translational renal research with interests in renal pharmacology, renal pathophysiology and drug nephrotoxicity, linked to the ongoing clinical research interests in the regulation of renal and cardiovascular hemodynamics and AKI. His clinical research program addresses a long- standing interest in renal hemodynamics, drug-induced alterations in renal function and nephrotoxicity, the role of renovascular hormones in the control of hypertension and renal disease, and cardiovascular risk factors in kidney disease. Dr Walker has also participated in a number of pivotal trials including IDEAL, SHARP, ASFAST, and PERFECT, and authored over 180 publications. Until 2011, he was actively involved in the Scientific Programme and Education Commit- tee for the ANZSN, responsible for the scientific program of its annual scientific meeting as well as overseeing the society s education program. Professor Walker is a member of the ISN Nexus and Forefronts Committees, as well as serving on the Caring for Australasians with Renal Impairment guideline committees for cardiovascular risk factors in renal disease and dialysis adequacy. He is also an Executive Council member of Asian Pacific Society of Nephrology and has a strong interest in developing links between Australia & New Zealand with South East Asia and the Pacific to further advance the scientific knowledge and research in all aspects of nephrology. Advisory Board: Fresenius SE Asia (no compensation) KDIGO CHAIRS Bertram L Kasiske, MD, is Professor of Medicine at the University of Minnesota, USA. He received his medical degree from the University of Iowa and completed his Internal Medicine residency and fellowship training in Nephrology at Hennepin County Medical Center where he is currently Director of Nephrology. Dr Kasiske is former Deputy Director of the United States Renal Data System and former Editor-in-Chief of American Journal of Kidney Diseases. He has served as Secretary/Treasurer and on the Board of Directors of the American Society of Transplantation, and on the Organ Procurement and Transplantation Network/United Network of Organ Sharing Board of Directors, and the Scientific Advisory Board of the US NKF. He is currently serving on the Board of Councilors of the ISN and he is the PI for a National Institutes of Health- sponsored, multicenter study of long-term outcomes after kidney donation. Dr Kasiske is the Director of the Scientific Registry of Transplant Recipients and has over 160 scientific publications in major peer-reviewed journals, and 230 review articles, editorials and textbook chapters. Dr Kasiske is also a recipient of the US NKF s Garabed Eknoyan Award in 2003. Advisory Board: Litholink/Labcorp Speaker: Merck Japan David C Wheeler, MD, FRCP, holds an academic position in Nephrology (Reader) at University College London, UK and is an Honorary Consultant Nephrologist at the Royal Free Hospital. His research is focused on the cardiovascular complications of CKD and the role of vascular risk factors in progression of kidney damage. Dr Wheeler is a member of the International Steering Committee of SHARP and was UK National Coordinator for the trial. He is involved in several other randomized trials and observational studies involving patients with CKD. Dr Wheeler is Co-Chair of KDIGO, having served previously on its Executive Committee and Board. He received an International Distinguished Medal from the US NKF in recognition of his contribution to guideline development. In the UK, he has been elected President of the Renal Association for the term 2012-2014. Dr Wheeler has served on the editorial boards of American Journal of Kidney Diseases and Journal of the American Society of Nephrology and is presently Co-Editor for Nephrology Dialysis Transplantation. Consultant: Amgen; Astellas; Baxter; Merck Sharp & Dohme; Otsuka; Vifor Grant/Research Support: Abbott;* AstraZeneca;* Genzyme* Speaker: Abbott; Amgen; Astellas; Fresenius Medical Care; Genzyme; Otsuka; Shire *monies paid to institution EVIDENCE REVIEW TEAM Ashish Upadhyay, MD, is Assistant Professor, Renal Section and Associate Director, Internal Medicine Residency Program at Boston University School of Medicine, Boston, MA, USA. Dr Upadhyay was previously Assistant Professor at Tufts University School of Medicine and staff physician in the William B Schwartz, MD, Division of Nephrology at Tufts Medical Center. He joined the ERT in July 2009 and served as the Assistant Project Director for the KDIGO Management of Blood Pressure in CKD and Anemia in CKD Guidelines. In the role as lead project director for this guideline, Dr Upadhyay coordinated and assisted in the collection, evaluation, grading, and synthesis of evidence, and played a critical role in the revisions of the final evidence report. He also provided methodological guidance and training of Work Group members on topic refinement, key question formula- tion, data extraction, study assessment, evidence grading, and recommendation formulation. Dr Upadhyay s past research involved studying kidney disease epidemiology in the Framingham Heart Study. He has published in areas ranging from arterial stiffness in CKD and inflammation in kidney biographic and disclosure information disease to dialysis complications and epidemiology of hyponatremia. Dr Upadhyay reported no relevant financial relationships Ethan M Balk, MD, MPH, is Director, Evidence-based Medicine at the Tufts Center for Kidney Disease Guideline Development and Implementation, in Boston, MA, USA, Associate Director of the Tufts Evidence-based Practice Center, and Associate Professor of Medicine at Tufts University School of Medicine. Dr Balk graduated from Tufts University School of Medicine and completed a fellowship in Clinical Care Research. As Program Director for this guideline, he played a role in providing methodological expertise in the guideline development process and assisted in the collection, evaluation, grading, and synthesis of evidence and the revisions of the final evidence report. Dr Balk also provided methodological guidance and training of Work Group members regarding topic refinement, key question formulation, data extraction, study assessment, evidence grading, and recommendation formulation. His primary research interests are evidence-based medicine, systematic review, clinical practice guideline deve- lopment, and critical literature appraisal. Dr Balk reported no relevant financial relationships Amy Earley, BS, is a project coordinator at the Tufts Center for Kidney Disease Guideline Development and Implementation in Boston, MA, USA. She is key in coordinating the guideline development activities within the ERT, especially in the development of the evidence reports for all guidelines. Ms Earley also heads the actual evidence review, which includes running searches, screening, data extraction, drafting of tables and methods sections, proofing of guideline drafts, and critical literature appraisals. She participates in the conduct of research projects at the Center and actively collaborates with other members of the Center on independent research topics and manuscript submissions. Ms Earley reported no relevant financial relationships Shana Haynes, MS, DHSc, is a research assistant at the Tufts Center for Kidney Disease Guideline Development and Implementation in Boston, MA, USA. She participates in all aspects of evidence review and guideline development. She screens abstracts and articles, extracts data, and assists in the drafting and editing of evidence tables. Dr Haynes also assists in the development of clinical practice guidelines and conducts systematic reviews and critical literature appraisals. Dr Haynes reported no relevant financial relationships Jenny Lamont, MS, is a project manager and medical writer at the Tufts Center for Kidney Disease Guideline Development and Implementation in Boston, MA, USA. She participates in all aspects of evidence review and guideline development, assists in the preparation of talks and manuscripts, and edits KDIGO draft guidelines currently in progress. Ms Lamont reported no relevant financial relationships. biographic and disclosure information Acknowledgments A special debt of gratitude is owed to the KDIGO Co-Chairs, Bertram Kasiske and David Wheeler, and the KDIGO Board for their invaluable guidance throughout the development of this guideline. In particular, we thank the ERT members: Ashish Upadhyay, Ethan Balk, Amy Earley, Shana Haynes, and Jenny Lamont for their substantial contribution to the rigorous assessment of the available evidence. We are also especially grateful to the Work Group members for their expertise throughout the entire process of literature review, data extraction, meeting participation, the critical writing and editing of the statements and rationale, which made the publication of this guideline possible. The generous gift of their time and dedication is greatly appreciated. Finally, and on behalf of the Work Group, we gratefully acknowledge the careful assessment of the draft guideline by 268 external reviewers. The Work Group considered all of the valuable comments made and, where appropriate, suggested changes were incorporated into the final publication. Marcello A Tonelli, MD, SM, FRCPC Christoph Wanner, MD Work Group Co-Chairs acknowledgments http://www.kidney-international.org & 2013 KDIGO References REFERENCES 1. National Kidney Foundation. K/DOQI clinical practice guidelines for management of dyslipidemias in patients with kidney disease. Am J Kidney Dis 2003; 41: S1 92. 2. National Kidney Foundation. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis 2007; 49: S1 180. 3. Kasiske BL. Hyperlipidemia in patients with chronic renal disease. Am J Kidney Dis 1998; 32: S142 156. 4. Bachorik PS, Ross JW. 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