KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease

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1 Official Journal of the International Society of Nephrology KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease volume 3 issue 1 JANUARY 2013

2 KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease KDIGO gratefully acknowledges the following consortium of sponsors that make our initiatives possible: Abbott, Amgen, Bayer Schering Pharma, Belo Foundation, Bristol-Myers Squibb, Chugai Pharmaceutical, Coca-Cola Company, Dole Food Company, Fresenius Medical Care, Genzyme, Hoffmann-LaRoche, JC Penney, Kyowa Hakko Kirin, NATCO The Organization for Transplant Professionals, NKF-Board of Directors, Novartis, Pharmacosmos, PUMC Pharmaceutical, Robert and Jane Cizik Foundation, Shire, Takeda Pharmaceutical, Transwestern Commercial Services, Vifor Pharma, and Wyeth. Sponsorship Statement: KDIGO is supported by a consortium of sponsors and no funding is accepted for the development of specific guidelines.

3 & 2013 KDIGO contents VOL 3 ISSUE 1 JANUARY (1) 2013 KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease v vii viii x xi xii Tables and Figures KDIGO Board Members Reference Keys CKD Nomenclature Conversion Factors & HbA 1c Conversion Abbreviations and Acronyms Notice Foreword Work Group Membership Abstract Summary of Recommendation Statements Introduction: The case for updating and context Chapter 1: Definition, and classification of CKD Chapter 2: Definition, identification, and prediction of CKD progression Chapter 3: Management of progression and complications of CKD Chapter 4: Other complications of CKD: CVD, medication dosage, patient safety, infections, hospitalizations, and caveats for investigating complications of CKD Chapter 5: Referral to specialists and models of care Methods for Guideline Development Biographic and Disclosure Information Acknowledgments References This journal is a member of, and subscribes to the principles of, the Committee on Publication Ethics (COPE)

4 & 2013 KDIGO contents TABLES Table 1. Table 2. Table 3. Table 4. Table 5. Table 6. Table 7. Table 8. Table 9. Table 10. Table 11. Table 12. Table 13. Table 14. Table 15. Table 16. Table 17. Table 18. Table 19. Table 20. Table 21. Table 22. Table 23. Table 24. Table 25. Table 26. Table 27. Table 28. Table 29. Table 30. Table 31. Table 32. Table 33. Table 34. Table 35. Table 36. Table 37. Table 38. Table 39. Table 40. Table 41. Table 42. Table 43. Table 44. Table 45. KDIGO nomenclature and description for grading recommendations Criteria for CKD Criteria for definition of CKD Classification of CKD based on presence or absence of systemic disease and location within the kidney of pathologic-anatomic findings GFR categories in CKD Albuminuria categories in CKD Relationship among categories for albuminuria and proteinuria CGA staging of CKD: examples of nomenclature and comments Prognosis of CKD: Relationship of outcomes and strength of relationship to Cause (C), GFR (G), Albuminuria (A) and other measures Annual percentage change in GFR across diagnosis categories Sources of error in GFR estimating using creatinine Equations based on serum creatinine assays in adults that are traceable to the standard reference material Performance comparison of creatinine-based GFR estimating equations in North America, Europe, and Australia Performance comparison of creatinine-based GFR estimating equations outside of North America, Europe, and Australia Sources of error in GFR estimating using cystatin C Equations based on IDMS traceable creatinine and IFCC traceable cystatin C assays Performance comparison of cystatin C-based estimating equations in North American and European populations Strengths and limitations of GFR measurement methods and markers Factors affecting urinary ACR Decline in kidney function in various populations (longitudinal studies only) Decline in kidney function in CKD populations Studies evaluating rapid progression (general population studies only) CKD progression and risk of all-cause mortality and ESRD using baseline (first) egfr Association between absolute and percentage change in kidney function and risk of ESRD, based on adjustment for egfr at the first and last measurement Intensive versus normal glycemic control and albuminuria outcome Recommended Daily Intake of sodium for healthy children Prevalence of CKD complications by GFR category derived from CKD cohorts Hemoglobin cutoffs for people living at sea level Phosphate binding agents in routine clinical practice and their ranked cost Summary data for bisphosphonates and CKD Peripheral arterial disease and CKD Cautionary notes for prescribing in people with CKD Risk factors for infection in people with CKD Components of community CKD management programs Early versus late referral: consequences and benefits Outcomes of early versus late referral Topics of interest for the management of CKD guideline Literature yield of primary articles for all topics Classification of study quality GRADE system for grading quality of evidence Final grade for overall quality of evidence Balance of benefits and harm KDIGO nomenclature and description for grading recommendations Determinants of strength of recommendation The Conference on Guideline Standardization checklist for reporting clinical practice guidelines Kidney International Supplements (2013) 3, v v

5 contents & 2013 KDIGO FIGURES Figure 1. Conceptual model of CKD Figure 2. Normal values for GFR by age Figure 3. Relationship of egfr with mortality Figure 4. Relationship of albuminuria with mortality Figure 5. Age-standardized rates of death from any cause, cardiovascular events, and hospitalization, according to the egfr among 1,120,295 ambulatory adults Figure 6. Summary of continuous meta-analysis for general population cohorts with ACR Figure 7. Summary of categorical meta-analysis for general population cohorts with ACR Figure 8. Prevalence of CKD in the USA by GFR and albuminuria Figure 9. Prognosis of CKD by GFR and albuminuria category Figure 10. Determinants of the serum level of endogenous filtration markers Figure 11. Performance of the CKD-EPI and MDRD Study equations in estimating measured GFR in the external validation data set Figure 12. Comparison of distribution of GFR and CKD prevalence by age (NHANES ) Figure 13. Meta-analysis of NRI for all-cause mortality, CVD mortality, and ESRD Figure 14. Association of CKD definitions with all-cause mortality and ESRD Figure 15. Performance of three equations for estimating GFR Figure 16. Suggested protocol for the further investigation of an individual demonstrating a positive reagent strip test for albuminuria/proteinuria or quantitative albuminuria/proteinuria test Figure 17. GFR and albuminuria grid to reflect the risk of progression Figure 18. Distribution of the probability of nonlinearity with three example trajectories demonstrating different probabilities of nonlinearity Figure 19. Summary estimates for risks of all-cause mortality and cardiovascular mortality associated with levels of serum phosphorus, PTH, and calcium Figure 20. Prevalence of deficiency of 1,25(OH) 2 D 3, 25(OH)D 3, and secondary hyperparathyroidism by GFR intervals Figure 21. Referral decision making by GFR and albuminuria Figure 22. The CKD chronic care model Additional information in the form of supplementary materials can be found online at vi Kidney International Supplements (2013) 3, vi

6 & 2013 KDIGO KDIGO Board Members Garabed Eknoyan, MD Norbert Lameire, MD, PhD Founding KDIGO Co-Chairs Kai-Uwe Eckardt, MD Immediate Past Co-Chair Bertram L Kasiske, MD KDIGO Co-Chair David C Wheeler, MD, FRCP KDIGO Co-Chair Omar I Abboud, MD, FRCP Sharon Adler, MD, FASN Rajiv Agarwal, MD Sharon P Andreoli, MD Gavin J Becker, MD, FRACP Fred Brown, MBA, FACHE Daniel C Cattran, MD, FRCPC Allan J Collins, MD, FACP Rosanna Coppo, MD Josef Coresh, MD, PhD Ricardo Correa-Rotter, MD Adrian Covic, MD, PhD Jonathan C Craig, MBChB, MM (Clin Epi), DCH, FRACP, PhD Angel LM de Francisco, MD Paul E de Jong, MD, PhD Ana Figueiredo, RN, MSc, PhD Mohammed Benghanem Gharbi, MD Gordon Guyatt, MD, MSc, BSc, FRCPC David Harris, MD Lai Seong Hooi, MD Enyu Imai, MD, PhD Lesley A Inker, MD, MS, FRCP Michel Jadoul, MD Simon Jenkins, MBE, FRCGP Suhnggwon Kim, MD, PhD Martin K Kuhlmann, MD Nathan W Levin, MD, FACP Philip K-T Li, MD, FRCP, FACP Zhi-Hong Liu, MD Pablo Massari, MD Peter A McCullough, MD, MPH, FACC, FACP Rafique Moosa, MD Miguel C Riella, MD Adibul Hasan Rizvi, MBBS, FRCP Bernardo Rodriquez-Iturbe, MD Robert Schrier, MD Justin Silver, MD, PhD Marcello Tonelli, MD, SM, FRCPC Yusuke Tsukamoto, MD Theodor Vogels, MSW Angela Yee-Moon Wang, MD, PhD, FRCP Christoph Wanner, MD Elena Zakharova, MD, PhD NKF-KDIGO GUIDELINE DEVELOPMENT STAFF Kerry Willis, PhD, Senior Vice-President for Scientific Activities Michael Cheung, MA, Guideline Development Director Sean Slifer, BA, Guideline Development Manager Kidney International Supplements (2013) 3, vii vii

7 & 2013 KDIGO 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, ord. Implications Grade* 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 evaluated as a candidate for developing a policy or a performance measure. 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 substantial 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. Grade Quality of evidence Meaning A High We are confident that the true effect lies close to that of the estimate of the effect. B Moderate 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 The true effect may be substantially different from the estimate of the effect. D Very low The estimate of effect is very uncertain, and often will be far from the truth. ADULT GFR ESTIMATING EQUATIONS 2009 CKD-EPI creatinine equation: 141 min(scr/k, 1) a max(scr/k, 1) Age [ if female] [ if black], where SCr is serum creatinine (in mg/dl), k is 0.7 for females and 0.9 for males, a is for females and for males, min is the minimum of SCr/k or 1, and max is the maximum of SCr/k or 1. Equations expressed for specified sex and serum creatinine level Gender Serum creatinine Equation for estimating GFR Female p0.7 mg/dl (p62 mmol/l) 144 (SCr/0.7) Age [ if black] Female 40.7 mg/dl (462 mmol/l) 144 (SCr/0.7) Age [ if black] Male p0.9 mg/dl (p80 mmol/l) 141 (SCr/0.9) Age [ if black] Male 40.9 mg/dl (480 mmol/l) 141 (SCr/0.9) Age [ if black] 2012 CKD-EPI cystatin C equation: 133 min(scysc/0.8, 1) max(scysc/0.8, 1) Age [ if female], where SCysC is serum cystatin C (in mg/l), min indicates the minimum of SCysC/0.8 or 1, and max indicates the maximum of SCysC/0.8 or 1. Equations expressed for serum cystatin C level Serum cystatin C Equation for estimating GFR Female or male p0.8 mg/l 133 (SCysC/0.8) Age [ if female] Female or male 40.8 mg/l 133 (SCysC/0.8) Age [ if female] viii Kidney International Supplements (2013) 3, viii

8 & 2013 KDIGO 2012 CKD-EPI creatinine cystatin C equation: 135 min(scr/k, 1) a max(scr/k, 1) min(scysc/0.8, 1) max(scysc/ 0.8, 1) Age [ if female] [ 1.08 if black], where SCr is serum creatinine (in mg/dl), SCysC is serum cystatin C (in mg/l), k is 0.7 for females and 0.9 for males, a is for females and for males, min(scr/k, 1) indicates the minimum of SCr/k or 1, and max(scr/k, 1) indicates the maximum of SCr/k or 1; min(scysc/0.8, 1) indicates the minimum of SCysC/0.8 or 1 and max(scysc/ 0.8, 1) indicates the maximum of SCysC/0.8 or 1. Equations expressed for specified sex, serum creatinine, and serum cystatin C level Gender Serum creatinine Serum cystatin C Equation for estimating GFR Female p0.7 mg/dl (p62 mmol/l) p0.8 mg/l 40.8 mg/l Female 40.7 mg/dl (462 mmol/l) p0.8 mg/l 40.8 mg/l Male p0.9 mg/dl (p80 mmol/l) p0.8 mg/l 40.8 mg/l Male 40.9 mg/dl (480 mmol/l) p0.8 mg/l 40.8 mg/l 130 (SCr/0.7) (SCysC/0.8) Age [ 1.08 if black] 130 (SCr/0.7) (SCysC/0.8) Age [ 1.08 if black] 130 (SCr/0.7) (SCysC/0.8) Age [ 1.08 if black] 130 (SCr/0.7) (SCysC/0.8) Age [ 1.08 if black] 135 (SCr/0.9) (SCysC/0.8) Age [ 1.08 if black] 135 (SCr/0.9) (SCysC/0.8) Age [ 1.08 if black] 135 (SCr/0.9) (SCysC/0.8) Age [ 1.08 if black] 135 (SCr/0.9) (SCysC/0.8) Age [ 1.08 if black] PEDIATRIC GFR ESTIMATING EQUATIONS Creatinine-based equations 41.3 (height/scr) 40.7 (height/scr) 0.64 (30/BUN) BUN, blood urea nitrogen in mg/dl; height in meters; SCr, serum creatinine in mg/dl SCysC, serum cystatin C in mg/l. Cystatin C-based equations (SCysC) Kidney International Supplements (2013) 3, ix ix

9 CURRENT CHRONIC KIDNEY DISEASE (CKD) NOMENCLATURE USED BY KDIGO & 2013 KDIGO CKD is defined as abnormalities of kidney structure or function, present for 43 months, with implications for health and CKD is classified based on cause, GFR category, and albuminuria category (CGA). Prognosis of CKD by GFR and albuminuria category Persistent albuminuria categories Description and range Prognosis of CKD by GFR and Albuminuria Categories: KDIGO 2012 A1 A2 A3 Normal to mildly increased Moderately increased Severely increased <30 mg/g <3 mg/mmol mg/g 3-30 mg/mmol >300 mg/g >30 mg/mmol GFR categories (ml/min/ 1.73 m 2 ) Description and range G1 Normal or high 90 G2 Mildly decreased G3a G3b Mildly to moderately decreased Moderately to severely decreased G4 Severely decreased G5 Kidney failure <15 Green: low risk (if no other markers of kidney disease, no CKD); Yellow: moderately increased risk; Orange: high risk; Red, very high risk. x Kidney International Supplements (2013) 3, x

10 & 2013 KDIGO CONVERSION FACTORS OF METRIC UNITS TO SI UNITS Parameter Metric units Conversion factor SI units Albumin (serum) g/dl 10 g/l Blood urea nitrogen (BUN) mg/dl mmol/l Creatinine (serum) mg/dl 88.4 mmol/l Creatinine clearance ml/min ml/s Hemoglobin g/dl 10 g/l Phosphate (serum) mg/dl mmol/l PTH (parathyroid hormone, serum) pg/ml pmol/l Urea (plasma) mg/dl mmol/l Uric acid mg/dl mmol/l Vitamin D, 25-hydroxyvitamin D ng/ml nmol/l Note: Metric unit conversion factor ¼ SI unit. HbA 1C CONVERSION CHART DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) DCCT (%) IFCC (mmol/mol) IFCC-HbA 1c (mmol/mol) ¼ [DCCT-HbA 1c (%) 2.15] Abbreviations: DCCT, Diabetes Control and Complications Trial; IFCC, International Federation of Clinical Chemistry and Laboratory Medicine. Source: Diabetes UK, Kidney International Supplements (2013) 3, xi xi

11 & 2013 KDIGO Abbreviations and Acronyms 4C Cardiovascular Comorbidity in Children with CKD AASK African American Study of Kidney Disease and Hypertension ABPM Ambulatory blood pressure monitoring ACCORD Action to Control Cardiovascular Risk in Diabetes ACE-I Angiotensin-converting enzyme inhibitor ACR Albumin-to-creatinine ratio ACS Acute coronary syndrome ADVANCE Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation AER Albumin excretion rate AGREE Appraisal of Guidelines for Research and Evaluation AKD Acute kidney disease AKDN Alberta Kidney Disease Network AKI Acute kidney injury ANP Atrial natriuretic peptide APPROACH Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease AusDiab Australian Diabetes, Obesity and Lifestyle study ARB Angiotensin-receptor blocker BMD Bone mineral density BMI Body mass index BNP B-type natriuretic peptide BP Blood pressure BSA Body surface area BUN Blood urea nitrogen CAD Coronary artery disease CAPRICORN Carvedilol Post-Infarct Survival Control in Left Ventricular Dysfunction CGA Cause, GFR and Albuminuria categories CHARM Candesartan in Heart Failure-Assessment of Reduction in Mortality and Morbidity CHF Congestive heart failure CHS Cardiovascular Health Study CI Confidence interval CIBIS II Cardiac Insufficiency Bisoprolol Study II CKD Chronic kidney disease CKD-EPI CKD Epidemiology Collaboration CKD-MBD Chronic Kidney Disease-Mineral and Bone Disorder CKiD Chronic Kidney Disease in Children COGS Conference on Guideline Standardization COPERNICUS Carvedilol Prospective Randomized Cumulative Survival COX-2 Cyclooxygenase-2 Cr-EDTA Chromium-ethylenediamine tetraacetic acid CREATE Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta Trial CREDO Clopidogrel for Reduction of Events During Observation CrCl Creatinine clearance CRIC Chronic Renal Insufficiency Cohort CRP C-reactive protein ctni Cardiac troponin I ctnt Cardiac troponin T CVD Cardiovascular disease DCCT/EDIC Diabetes Control and Complications Trial/ Epidemiology of Diabetes Interventions and Complications DIG Digitalis Intervention Group DPI Dietary protein intake DXA Dual-energy x-ray absorptiometry ECG Electrocardiography egfr Estimated GFR EMU Early morning urine ERT Evidence review team ESA Erythropoiesis-stimulating agent ESCAPE Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure in Pediatric Patients ESRD End-Stage Renal Disease ESUR European Society of Urogenital Radiology FGF-23 Fibroblast growth factor-23 GBCA Gadolinium-based contrast agent GFR Glomerular filtration rate GN Glomerulonephritis GRADE Grading of Recommendations Assessment, Development and Evaluation Hb Hemoglobin HbA 1c Hemoglobin A1c HBV Hepatitis B virus HDL-C High-density lipoprotein cholesterol HOPE Heart Outcomes Prevention Evaluation HOT Hypertension Optimal Treatment HR Hazard ratio HR-pQCT High-resolution peripheral quantitative computed tomography HUNT 2 Nord-Trøndelag Health Study ( ) ICD International Classification of Diseases ICU Intensive-care unit IDF International Diabetes Federation IDMS Isotope-dilution mass spectrometry IQR Interquartile range IRMM Institute for Reference Materials and Measurements ItalKid Italian Pediatric Registry of Chronic Renal Failure JCTLM Joint Committee for Traceability in Laboratory Medicine KDIGO Kidney Disease: Improving Global Outcomes KDOQI Kidney Disease Outcomes Quality Initiative LDL-C Low-density lipoprotein cholesterol LIFE Losartan Intervention For Endpoint Reduction in Hypertension LPD Low-protein diet LVH Left ventricular hypertrophy MAP Mean arterial pressure MDRD Modification of Diet in Renal Disease MESA Multi-Ethnic Study of Atherosclerosis Kidney International Supplements (2013) 3, xii xii

12 & 2013 KDIGO MI Myocardial infarction MRI Magnetic resonance imaging NAPRTCS North American Pediatric Renal Trials and Collaborative Studies NCEP III Third Report of the National Cholesterol Education Program NECOSAD Netherlands Cooperative Study on the Adequacy of Dialysis Study Group NHANES National Health and Nutrition Examination Survey NICE National Institute for Health and Clinical Excellence NIH National Institutes of Health NKDEP National Kidney Disease Education Program NKF National Kidney Foundation NSAID Nonsteroidal anti-inflammatory drug NSF Nephrogenic systemic fibrosis NT-proBNP N-terminal pro-bnp ONTARGET Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint trial OR Odds ratio PAD Peripheral arterial disease PCR Protein-to-creatinine ratio PER Protein excretion rate PICARD Program to Improve Care in Acute Renal Disease PICODD Population, Intervention or Predictor, Comparator, Outcome, study Design, and Duration of follow-up PREVEND Prevention of Renal and Vascular Endstage Disease PTH QOL RAAS RBC RCT RENAAL RR RRT SCORE SCr SCysC SD SEEK SHARP SPECT SUA TREAT UKPDS USA-PRC USRDS VADT Val-HeFT VLPD WBC WHO Parathyroid hormone Quality of life Renin-angiotensin-aldosterone system Red blood cell Randomized controlled trial Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan Relative risk Renal replacement therapy Systematic COronary Risk Evaluation Serum creatinine Serum cystatin C Standard deviation Study for the Evaluation of Early Kidney disease Study of Heart and Renal Protection Single photon emission computed tomography Serum uric acid Trial to Reduce Cardiovascular Events with Aranesp Therapy United Kingdom Prospective Diabetes Study USA People s Republic of China Collaborative Study of Cardiovascular and Cardiopulmonary Epidemiology US Renal Data System Veterans Affairs Diabetes Trial Valsartan Heart Failure Trial Very low-protein diet White blood cell World Health Organization Kidney International Supplements (2013) 3, xiii xiii

13

14 & 2013 KDIGO Notice Kidney International Supplements (2013) 3, 1; doi: /kisup SECTION I: USE OF THE CLINICAL PRACTICE GUIDELINE This Clinical Practice Guideline document is based upon systematic literature searches last conducted in June 2011, supplemented with additional evidence through November It is designed to provide information and assist decision making. 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 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 as or are 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 kept on file at the National Kidney Foundation (NKF), former Managing Agent for KDIGO. Copyright & 2012 by KDIGO. All rights reserved. Single photocopies may be made for personal use as allowed by national copyright laws. Special rates are available for educational institutions that wish to make photocopies for non-profit educational use. No part of this publication may be reproduced, amended, or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without explicit permission in writing from KDIGO. Details on how to seek permission for reproduction or translation, and further information about KDIGO s permissions policies can be obtained by contacting Danielle Green, Managing Director, at To the fullest extent of the law, neither KDIGO, Kidney International Supplements, National Kidney Foundation (KDIGO s former Managing Agent) nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. Kidney International Supplements (2013) 3, 1 1

15 & 2013 KDIGO Foreword Kidney International Supplements (2013) 3, 2; doi: /kisup 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 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 Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to rate the quality of evidence and the strength of recommendations. In all, there were 12 (17.1%) recommendations in this guideline for which the overall quality of evidence was graded A, whereas 36 (51.4%) were graded B, 17 (24.3%) were graded C, and 5 (7.1%) 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 43 (62.3%) recommendations graded 1 and 26 (37.7%) graded 2. There were 9 (13.0%) recommendations graded 1A, 23 (33.3%) were 1B, 10 (14.5%) were 1C, and 1 (1.4%) was 1D. There were 2 (2.9%) recommendations graded 2A, 13 (18.8%) were 2B, 7 (10.1%) were 2C, and 4 (5.8%) were 2D. There were 41 (37.3%) statements that were not graded. Some argue that recommendations should not be made when evidence is weak. However, clinicians still need to make 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 are often rated with a low strength of recommendation and a low quality of evidence, or were not graded. It is important for the users of this guideline to be cognizant of this (see Notice). 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 the Work Group Co-Chairs, Drs. Adeera Levin and Paul Stevens, 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. Bertram L Kasiske, MD KDIGO Co-Chair David C Wheeler, MD, FRCP KDIGO Co-Chair 2 Kidney International Supplements (2013) 3, 2

16 & 2013 KDIGO Work Group Membership Kidney International Supplements (2013) 3, 3; doi: /kisup Adeera Levin, MD, FRCPC University of British Columbia Vancouver, Canada WORK GROUP CO-CHAIRS Paul E Stevens, MB, FRCP East Kent Hospitals University NHS Foundation Trust Canterbury, United Kingdom WORK GROUP Rudy W Bilous, MD Newcastle University and James Cook University Hospital Middlesbrough, United Kingdom Josef Coresh, MD, PhD, MHS Johns Hopkins University Baltimore, USA Angel LM de Francisco, MD, PhD Hospital Universitario Valdecilla Santander, Spain Paul E de Jong, MD, PhD University Medical Center Groningen Groningen, The Netherlands Kathryn E Griffith, BM, BS, MSc, MRCP, MRCGP University Health Centre, York University York, United Kingdom Brenda R Hemmelgarn, MD, PhD, FRCP(C) University of Calgary Alberta, Canada Kunitoshi Iseki, MD University Hospital of the Ryukyus Nishihara, Okinawa, Japan Edmund J Lamb, PhD, FRCPath East Kent Hospitals University NHS Foundation Trust Canterbury, United Kingdom Andrew S Levey, MD Tufts Medical Center Boston, USA Miguel C Riella, MD, PhD, FACP Evangelic University Hospital Curitiba, Brazil Michael G Shlipak, MD, MPH VA Medical Center, UCSF San Francisco, USA Haiyan Wang, MD Peking University First Hospital Beijing, China Colin T White, MD, FRCPC University of British Columbia Vancouver, Canada Christopher G Winearls, MB, DPhil, FRCP Oxford Radcliffe Hospitals NHS Trust Oxford, United Kingdom EVIDENCE REVIEW TEAM Tufts Center for Kidney Disease Guideline Development and Implementation Tufts Medical Center, Boston, MA, USA: Katrin Uhlig, MD, MS, Project Director; Director, Guideline Development Dana Miskulin, MD, MS, Staff Nephrologist Amy Earley, BS, Project Coordinator Shana Haynes, MS, DHSc, Research Assistant Jenny Lamont, MS, Project Manager In addition, support and supervision were provided by: Ethan M Balk, MD, MPH; Program Director, Evidence Based Medicine Kidney International Supplements (2013) 3, 3 3

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