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Kidney-Failure-Giving-Smarter-Guide KIDNEY FAILURE AUTHORS LEAD AUTHOR Ekemini A. U. Riley, PhD CONTRIBUTING AUTHORS LaTese Briggs, PhD Erik Lontok, PhD Maura Donlan, MIA Ebony Mosley Sonya Dumanis, PhD Danielle Salka YooRi Kim, MS Melissa Stevens, MBA KIDNEY DISEASE SCIENTIFIC ADVISORY GROUP We graciously thank the members of and liaisons to the Kidney Disease Scientific Advisory Group for their participation and contribution to the Kidney Failure Project and Giving Smarter Guide. The informative discussions before, during, and after the Call to Action Retreat were critical to identifying the key unmet needs and ideal philanthropic opportunities to benefit patients and advance kidney disease research. Matthew Breyer, MD Jonathan Himmelfarb, MD Chief Scientific Officer—Lead Generation Professor of Medicine BioTechnology Discovery Research Director, Kidney Research Institute Eli Lilly and Company University of Washington Paul Conway Thomas Kleyman, MD President, American Association of Kidney Patients Chief, Renal-Electrolyte Division Board Member, Kidney Health Initiative Sheldon Adler Professor of Medicine Professor of Cell Biology, Pharmacology and Josef Coresh, MD Chemical Biology G.W. Comstock Professor of Epidemiology, University of Pittsburgh School of Medicine Biostatistics & Medicine CKD Prognosis Consortium Founding Leader Matthias Kretzler, MD Johns Hopkins University Warner-Lambert/Parke-Davis Professor of Medicine Nephrology/Internal Medicine and Laura Dember, MD Computational Medicine and Bioinformatics Professor of Medicine and Epidemiology University of Michigan Renal, Electrolyte and Hypertension Division University of Pennsylvania Jeffrey Lawson, MD, PhD Chief Medical Officer Jennifer Erickson Humacyte Assistant Director, Innovation for Growth Executive Office of the President Krista Lentine, MD, PhD Office of Science and Technology Policy Medical Director of Living Donation The White House Professor of Medicine Saint Louis University William Fissell, MD Associate Professor Andrew Levey, MD Nephrology and Hypertension Chief, Division of Nephrology Vanderbilt University Dr. Gerald J. and Dorothy R. Friedman Professor Tufts University School of Medicine 1 March 2017 Peter Linde, MD Roy Soberman, MD Vice President, Medical Research Associate Professor of Medicine Acceleron Pharma Harvard Medical School Nephrology Division Kenneth Newell, MD, PhD Massachusetts General Hospital Vice Chair for Academic Affairs Professor of Surgery Robert Stanton, MD Department of Surgery Associate Professor of Medicine Emory University Harvard Medical School Chief, Kidney & Hypertension Section Carmen A. Peralta, MD, MAS Joslin Diabetes Center Associate Professor of Medicine University of California San Francisco and San Katalin Susztak, MD, PhD Francisco VA Medical Center Associate Professor of Medicine Co-Founder and Executive Director Perelman School of Medicine Kidney Health Research Collaborative University of Pennsylvania Vlado Perkovic, MBBS, PhD Ravi Thadhani, MD, MPH Executive Director Professor of Medicine The George Institute Australia Harvard Medical School Professor of Medicine Chief, Division of Nephrology University of Sydney Massachusetts General Hospital Martin Pollak, MD Aliza Thompson, MD Professor of Medicine, Harvard Medical School Medical Officer Chief, Division of Nephrology Division of Cardiovascular and Renal Products Beth Israel Deaconess Medical Center Center for Drug Evaluation and Research (CDER) Food and Drug Administration Neil Powe, MD, MPH, MBA Chief of Medicine, Zuckerberg San Francisco General Roberta Weiss, MD Hospital Senior Director Constance B. Wofsy Distinguished Professor and Clinical Development, RIA Vice-Chair of Medicine MedImmune University of California San Francisco Melissa West Dorry Segev, MD, PhD Project Director, Kidney Health Initiative Marjory K. and Thomas Pozefsky Professor of Surgery American Society of Nephrology and Epidemiology Kerry Willis, PhD Associate Vice Chair, Department of Surgery Chief Science Officer Director, Epidemiology Research Group in Organ National Kidney Foundation Transplantation The Johns Hopkins University Myles Wolf, MD, MMSc Professor of Medicine Chief, Duke Nephrology Duke University School of Medicine 2 March 2017 TABLE OF CONTENTS Authors ................................................................................................................................................ 1 Kidney Disease Scientific Advisory Group ............................................................................................. 1 Philanthropists’ Foreword .................................................................................................................... 6 Executive Summary .............................................................................................................................. 8 Overview ............................................................................................................................................. 9 Societal Impact of Kidney Failure ..................................................................................................................... 9 Policy and Regulatory Initiatives .................................................................................................................... 11 Living Donor Protection Act of 2016 (H.R. 4616, S. 2584) ................................................................................. 11 The CKD Improvement in Research and Treatment Act of 2015 (H.R. 1130, S. 598) ........................................ 11 Quality Incentive Program ................................................................................................................................. 12 The Basics: The Kidneys and How They Work ..................................................................................... 13 Where are the Kidneys Located? .................................................................................................................... 13 How do the Kidneys Work? ............................................................................................................................ 13 Causal Factors, Risk Factors, and Prevention ...................................................................................... 15 General Risk Factors .......................................................................................................................................... 15 Genetic Risk Factors ........................................................................................................................................... 15 Prevention ......................................................................................................................................................... 15 Signs and Symptoms of Kidney Failure ............................................................................................... 16 Diagnosis ........................................................................................................................................... 17 Treatment .......................................................................................................................................... 19 Dialysis .......................................................................................................................................................... 19 Hemodialysis ...................................................................................................................................................... 19 Peritoneal Dialysis .............................................................................................................................................. 21 Complications Associated with Dialysis Treatment ........................................................................................... 21 Barriers Associated with Dialysis Treatment ..................................................................................................... 22 3 March 2017 Kidney Transplantation .................................................................................................................................. 22 Complications Associated with Kidney Transplantation .................................................................................... 23 Barriers Associated with Kidney Transplantation .............................................................................................. 23 Molecular Biology of Disease ............................................................................................................. 25 APOL1—A Key Genetic Risk Determinant in Kidney Failure ............................................................................ 25 The Renin-Angiotensin-Aldosterone System (RAAS)—A Therapeutic Target ................................................... 26 Clinical Trials and Investigational Therapies ....................................................................................... 27 Clinical Trials—Overview ............................................................................................................................... 27 Kidney Failure Clinical Trials ........................................................................................................................... 28 Investigational Therapies ............................................................................................................................... 28 Medical Device Development ...........................................................................................................................
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