Informing Clinical Practice in Nephrology: The Role of RCTs PDF
Preview Informing Clinical Practice in Nephrology: The Role of RCTs
Mohsen El Kossi Arif Khwaja Meguid El Nahas Editors Informing Clinical Practice in Nephrology The Role of RCTs 123 Informing Clinical Practice in Nephrology Mohsen El Kossi (cid:129) A rif Khwaja (cid:129) Meguid El Nahas Editors Informing Clinical Practice in Nephrology The Role of RCTs Editors Mohsen El Kossi , MBBCh, MSc, MD, FRCP Meguid El Nahas , MD, PhD, FRCP Doncaster Royal Infi rmary Sheffi eld Kidney Institute Doncaster Northern General Hospital UK Sheffi eld UK Arif Khwaja , FRCP, PhD Sheffi eld Kidney Institute Northern General Hospital Sheffi eld UK ISBN 978-3-319-10291-7 ISBN 978-3-319-10292-4 (eBook) DOI 10.1007/978-3-319-10292-4 Library of Congress Control Number: 2014960271 Springer Cham Heidelberg New York Dordrecht London © Springer International Publishing Switzerland 2015 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifi cally for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher’s location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. T he use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) Pref ace N ephrology practice has been informed over the last quarter of a century by a large number of clinical trials that translated animal experimentation fi ndings into the bedside. These clinical trials have also informed and shaped the Nephrology Practice Guidelines worldwide. However, a closer look at many of these clinical trials fi nds them wanting and reveals major fl aws that make their conclusions challengeable and their subsequent impact of practice mis- guided. Consequently, our practice and guidelines have been shaped in some instances by clinical trials that are inconclusive at best and misleading in their conclusions and recommen- dations at worst. This has prompted the editors of this monograph along with its publisher to call upon experts in the various fi elds of nephrology to undertake a thorough and critical appraisal and evaluation of the published clinical trials that have shaped our practice in recent times in gen- eral nephrology, dialysis, and transplantation. We have also included a critical appraisal tem- plate based on standard guidelines including the CONSORT statement to allow for a comparative evaluation of clinical trials within one area of nephrology and also across its dif- ferent fi elds: General Nephrology, Dialysis, and Transplantation. Of note, the implementation of the Critical Appraisal template was left entirely to individual authors’ evaluations. Parameters Yes No Comment Validity Is the Randomization Procedure well described? +1 −1 Double blinded ? +2 −2 Is the sample size calculation described/adequate? +3 −3 Does it have a hard primary e ndpoint ? +1 −1 Is the endpoint surrogate? −2 0 Is the follow-up appropriate? +1 −1 Was there a B ias ? −2 +2 Is the drop out >25 %? −1 +1 Is the analysis I TT ? +3 −3 Utility/Usefulness Can the fi ndings be generalized? +1 −1 Was the NNT <100? +1 −1 Score … The critical appraisals of mostly randomized clinical trials (RCT) have revealed the strength but also the weakness of the published literature upon which we base our current practice. W e hope that the monograph will alert nephrologists worldwide to the value of published RCT and provide them with a most valuable reference that assists them in their understanding and evaluation of key publications in nephrology. This in turn should allow them to better judge the literature upon which they base their daily clinical practice and avoid misplaced and unfounded assumptions. T he quality of the clinical practice and health care we deliver as nephrologists depend to a large extent on the quality of the RCT and publications we base our knowledge and guidelines upon. v Abbreviations AKI Acute kidney injury aAMR Acute antibody-mediated rejection ABPM Ambulatory blood pressure monitoring ADPKD Autosomal dominant polycystic kidney disease ALG Anti-lymphocyte globulin ATG Anti-thymocyte globulin ATP III Adult Treatment Panel III BUN Blood urea nitrogen CAC Coronary artery calcifi cation cAMR Chronic antibody-mediated rejection CAPD Continuous ambulatory peritoneal dialysis CKD Chronic kidney disease CKD-MBD Chronic kidney disease-mineral bone disorder CMV Cytomegalovirus CNIs Calcineurin inhibitors CRP C reactive protein CsA Cyclosporine A CSWD Corticosteroid withdrawal CTT Cholesterol treatment trialist CVD Cardiovascular disease DM Diabetes mellitus DOPPS Dialysis Outcomes and Practice Patterns Study DSA Donor-specifi c alloantibodies DSM Drug Safety and Monitoring eGFR Estimated glomerular fi ltration rate Epo Erythropoietin ESAs Erythropoiesis stimulating agents ESRD End stage renal disease FGF23 Fibroblast growth factor 23 FSGS Focal and segmental glomerulosclerosis Hb Hemoglobin HD Hemodialysis HMG-CO Hydroxymethylglutaryl-CoA IDPN Intradialytic parenteral nutrition IFG Impaired fasting glucose ITT Intention to treat KDIGO Kidney Disease Improving Global Outcomes KDOQI Kidney Disease Outcomes Quality Initiative LDL Low-density lipoprotein MACE Major adverse cardiovascular events MAP Mean arterial pressure MCD Minimal change disease vii viii Abbreviations MI Myocardial infarction MMF Mycophenolate mofetil MN Membranous nephropathy MPGN Membranoproliferative glomerulonephritis mTOR Mammalian target of rapamycin ND-CKD Nondialysis-dependent CKD NNT Number needed to treat NODAT New onset diabetes after transplant NYHA New York Heart Association OL-HDF Online hemodiafi ltration POC Proof of concept PP Per protocol PTLD Post-transplant lymphoproliferative disease RAAS Renin-angiotensin-aldosterone system RCT Randomized controlled trial RRT Renal replacement therapy SCC Squamous cell carcinoma SCD Sudden cardiac death SD Standard deviation TKV Total kidney volume UAER Urine albumin excretion rate VC Vascular calcifi cation Contents 1 Autosomal Dominant Polycystic Kidney Disease (ADPKD) Clinical Trials: A Critical Appraisal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Vimarsha G. Swami, Julious Okel, Nikhil Shah, Mark J. Courtney, and Aminu K. Bello 2 Lupus Nephritis Clinical Trials: A Critical Appraisal . . . . . . . . . . . . . . . . . . . . . . 17 Richard J. Glassock 3 ANCA-Associated Glomerulonephritis Clinical Trials: A Critical Appraisal . . . 33 Khalid Mahdi and Arif Khwaja 4 Acute Kidney Injury (AKI) Clinical Trials: A Critical Appraisal . . . . . . . . . . . . . 47 Yangmin Zeng and Adeera Levin 5 Chronic Kidney Disease (CKD) Clinical Trials: A Critical Appraisal . . . . . . . . . . 71 Meguid El Nahas 6 Anemia in Chronic Kidney Disease Clinical Trials: A Critical Appraisal . . . . . . 93 Mohsen El Kossi 7 Lipids and Chronic Kidney Disease Clinical Trials: A Critical Appraisal . . . . . 103 Mohsen El Kossi 8 Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD) Clinical Trials: A Critical Appraisal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Mohsen El Kossi and Arif Khwaja 9 Diabetic Nephropathy Clinical Trials: A Critical Appraisal . . . . . . . . . . . . . . . . 127 Meguid El Nahas and Bo Feldt-Rasmussen 10 Primary Glomerular Disease Clinical Trials: A Critical Appraisal . . . . . . . . . . . 153 Richard J. Glassock 11 Hemodialysis Clinical Trials: A Critical Appraisal . . . . . . . . . . . . . . . . . . . . . . . . 183 Charles Chazot 12 Peritoneal Dialysis Clinical Trials: A Critical Appraisal . . . . . . . . . . . . . . . . . . . 199 Simon J. Davies 13 Renal Transplantation Clinical Trials: A Critical Appraisal . . . . . . . . . . . . . . . . 219 Lionel Rostaing and Richard J. Baker General Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243 ix
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