Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease (AMPLITUDE)

April 16, 2026 updated by: Vertex Pharmaceuticals Incorporated

A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.

Study Overview

Status

Recruiting

Conditions

Proteinuric Kidney Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

466

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Medical Information
Phone Number: 617-341-6777
Email: medicalinfo@vrtx.com

Study Locations

Belgium
- - Leuven, Belgium
    - Recruiting
    - Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology
- Brussels Capital
  - Woluwe-Saint-Lambert, Brussels Capital, Belgium
    - Recruiting
    - Universite Catholique de Louvain - Pulmonology
Brazil
- - Aracaju, Brazil
    - Recruiting
    - Centro de Pesquisa Clinica do Coracao
  - Belo Horizonte, Brazil
    - Recruiting
    - Santa Casa de Misericordia de Belo Horizonte
  - Botucatu, Brazil
    - Recruiting
    - Faculdade de Medicina de Botucatu - CKD and Hypertension Department
  - Botucatu, Brazil
    - Recruiting
    - Faculdade de Medicina de Botucatu - Kidney Transplantation Department
  - Campinas, Brazil
    - Recruiting
    - IPECC - Instituto de Pesquisa Clínica de Campinas
  - Curitiba, Brazil
    - Recruiting
    - Instituto Pro-Renal
  - Curitiba, Brazil
    - Completed
    - PUC Trials - Unidade Epicenter
  - Fortaleza, Brazil
    - Recruiting
    - Walter Cantídio University Hospital
  - Fortaleza, Brazil
    - Recruiting
    - Instituto de Ensino e Pesquisa Clinica do Ceara
  - Goiânia, Brazil
    - Recruiting
    - Federal University of Goiás (UFG)
  - Juiz de Fora, Brazil
    - Recruiting
    - Cmip-Centro Mineiro de Pesquisa Ltda
  - Juiz de Fora, Brazil
    - Completed
    - Galileo Medical Research LTDA
  - Marília, Brazil
    - Recruiting
    - ICM - Instituto do Coracao de Marilia
  - Monte Alegre, Brazil
    - Recruiting
    - Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  - Porto Alegre, Brazil
    - Terminated
    - Dom Vicente Scherer Hospital
  - Porto Alegre, Brazil
    - Completed
    - Hospital de Clínicas de Porto Alegre - Nephrology
  - Recife, Brazil
    - Recruiting
    - Centro de Pesquisa Clinica Professor Salomao Kelner
  - Rio de Janeiro, Brazil
    - Completed
    - Hospital Sao Lucas
  - Rio de Janeiro, Brazil
    - Recruiting
    - Hospital Universitario Pedro Ernesto - Departamento de Nefrologia
  - Rio de Janeiro, Brazil
    - Recruiting
    - Hospital Universitario Pedro Ernesto - Departamento de Patologia
  - Salvador, Brazil
    - Recruiting
    - CSB Group of Nephrology Brazil
  - Salvador, Brazil
    - Recruiting
    - Hospital Ana Nery/SESAB
  - Salvador, Brazil
    - Recruiting
    - Comlexo Hospitalar Universitário Professor Edgard Santos
  - Santo André, Brazil
    - Recruiting
    - Praxis Pesquisa Medica
  - São José do Rio Preto, Brazil
    - Completed
    - Fundação Faculdade Regional de Medicina de São José do Rio Preto
  - São Paulo, Brazil
    - Recruiting
    - Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular
  - São Paulo, Brazil
    - Recruiting
    - Hospital do Rim - Fundação Oswaldo Ramos
  - São Paulo, Brazil
    - Recruiting
    - Hospital Nove de Julho - Nephrology
  - São Paulo, Brazil
    - Recruiting
    - Irmandade Da Santa Casa De Misericordia De Sao Paulo
Canada
- - Montreal, Canada
    - Completed
    - Recherche GCP Research
  - Toronto, Canada
    - Recruiting
    - Women's College Hospital
Colombia
- - Atlántico, Colombia
    - Recruiting
    - Clinica de la Costa S.A.S
  - Bogotá, Colombia
    - Recruiting
    - Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO
  - Cali, Colombia
    - Recruiting
    - Fundacion Valle del Lili
  - Cartagena, Colombia
    - Recruiting
    - Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS
  - Ibague, Colombia
    - Recruiting
    - Mediservis del Tolima IPS S.A.S.
  - Medellín, Colombia
    - Recruiting
    - Fundación Hospitalaria San Vicente de Paul
  - Medellín, Colombia
    - Recruiting
    - Promotora Medica Las Americas S.A. - Clinica Las Americas
France
- - Créteil, France
    - Recruiting
    - Hopital Henri Mondor - Nephrology
  - Grenoble, France
    - Recruiting
    - Hospital Nord Michallon - Nephrology
  - Le Kremlin-Bicêtre, France
    - Recruiting
    - Bicetre Hospital
  - Limoges, France
    - Recruiting
    - CHU Dupuytren 2 - Néphrologie, dialyse, transplantations
  - Marseille, France
    - Recruiting
    - Hopital de la Conception
  - Paris, France
    - Recruiting
    - Ambroise Paré Hospital
  - Paris, France
    - Recruiting
    - Hopital Necker Enfants Malades - Nephrology
  - Paris, France
    - Completed
    - Hopital Tenon
  - Paris, France
    - Completed
    - Université Paris-Descartes / Hôpital Européen Georges Pompidou
  - Pointe à Pitre, France
    - Recruiting
    - CHU de Guadeloupe
  - Saint-Ouen, France
    - Recruiting
    - AURA Nord
  - Toulouse, France
    - Completed
    - Hôpital de Rangueil
Ghana
- - Accra, Ghana
    - Recruiting
    - University of Ghana Medical School - Nephrology
  - Cantonments, Ghana
    - Recruiting
    - The Bank Hospital
  - Kumasi, Ghana
    - Recruiting
    - Komfo Anokye Teaching Hospital - Nephrology
Netherlands
- - Amsterdam, Netherlands
    - Completed
    - Amsterdam UMC - Amsterdam Public Health Research Institute
Nigeria
- - Enugu, Nigeria
    - Recruiting
    - University of Nigeria Teaching Hospital
  - Ibadan, Nigeria
    - Recruiting
    - University College Hospital
  - Idi Araba, Nigeria
    - Recruiting
    - Lagos University Teaching Hospital
  - Ikeja, Nigeria
    - Recruiting
    - Lagos State University Teaching Hospital
  - Lagos, Nigeria
    - Recruiting
    - Nigerian Institute of Medical Research
Portugal
- - Amadora, Portugal
    - Completed
    - Unidade Local de Saude Amadora/Sintra, E.P.E.
  - Lisbon, Portugal
    - Completed
    - Hospital Curry Cabral - Serviço de Nefrologia
  - Lisbon, Portugal
    - Completed
    - Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology
  - Loures, Portugal
    - Completed
    - Unidade Local de Saúde de Loures-Odivelas, E.P.E.
Puerto Rico
- - Mayagüez, Puerto Rico, 06680
    - Recruiting
    - FDI Clinical Research
  - Rio Piedras, Puerto Rico, 00935
    - Recruiting
    - University of Puerto Rico
  - San Juan, Puerto Rico, 00917
    - Completed
    - GCM Medical Group, PSC
Spain
- - Barcelona, Spain
    - Completed
    - Hospital Clinic de Barcelona - Nephrology
  - Barcelona, Spain
    - Completed
    - Hospital Universitari Vall d´Hebron - Servicio de Pediatria
  - Córdoba, Spain
    - Completed
    - Reina Sofia University Hospital - Nephrology
  - Madrid, Spain
    - Completed
    - Hospital Universitario 12 de Octubre - Nephrology
  - Seville, Spain
    - Completed
    - Hospital Universitario Virgen Macarena
United Kingdom
- - Basildon, United Kingdom
    - Recruiting
    - Mid and South Essex Hospitals NHS Trust
  - Bellshill, United Kingdom
    - Recruiting
    - Synexus Clinical Research - Glasgow (DRS)
  - Birmingham, United Kingdom
    - Recruiting
    - Queen Elizabeth Hospital Birmingham
  - Birmingham, United Kingdom
    - Recruiting
    - Synexus Clinical Research - Midlands (DRS)
  - Birmingham, United Kingdom
    - Completed
    - FutureMeds Birmingham
  - Carshalton, United Kingdom
    - Completed
    - Epsom and St Helier University Hospitals NHS Trust
  - Leicester, United Kingdom
    - Recruiting
    - Leicester General Hospital
  - London, United Kingdom
    - Recruiting
    - St Pancras Clinical Research
  - London, United Kingdom
    - Completed
    - Great Ormond Street Hospital for Children
  - London, United Kingdom
    - Recruiting
    - Guy's Hospital - Endocrinology
  - London, United Kingdom
    - Recruiting
    - King's College Hospital - Pulmonology
  - London, United Kingdom
    - Recruiting
    - Royal Free Hospital - Nephrology
  - London, United Kingdom
    - Recruiting
    - St George's Hospital London - Nephrology
  - London, United Kingdom
    - Recruiting
    - The Royal London Hospital - Nephrology
  - Manchester, United Kingdom
    - Recruiting
    - Manchester Royal Infirmary - Endocrinology
  - Manchester, United Kingdom
    - Recruiting
    - Synexus Clinical Research - NW Consortium Manchester (DRS)
  - Manchester, United Kingdom
    - Recruiting
    - Wythenshawe Hospital - Medicines Evaluation Unit
  - Nottingham, United Kingdom
    - Recruiting
    - Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology
United States
- Alabama
  - Alabaster, Alabama, United States, 35007
    - Recruiting
    - Alabama Kidney Research
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - Children's Hospital of Alabama
  - Birmingham, Alabama, United States, 35210
    - Recruiting
    - EmVenio Research - Mobile Unit - Birmingham
  - Birmingham, Alabama, United States, 35294
    - Recruiting
    - The Kirklin Clinic - Nephrology
  - Birmingham, Alabama, United States, 35211
    - Completed
    - Cardiology, P.C.
  - Fairhope, Alabama, United States, 36532
    - Recruiting
    - Nephrology Associates
  - Huntsville, Alabama, United States, 35805
    - Recruiting
    - Nephrology Consultants, LLC
  - Huntsville, Alabama, United States, 35801
    - Recruiting
    - Heart Center Research Llc
  - Montgomery, Alabama, United States, 36117
    - Recruiting
    - Renal Associates of Alabama, LLC
- Arizona
  - Mesa, Arizona, United States, 85202
    - Withdrawn
    - Arizona Kidney Disease and Hypertension Center - Banner Desert Office
  - Phoenix, Arizona, United States, 85016
    - Recruiting
    - Arizona Kidney Disease and Hypertension Center - Thomas Office
  - Phoenix, Arizona, United States, 85016
    - Recruiting
    - Phoenix Children's Hospital, Inc. - Nephrology
- Arkansas
  - Little Rock, Arkansas, United States, 72204
    - Completed
    - CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock
  - Little Rock, Arkansas, United States, 72205
    - Completed
    - UAMS Medical Center - Pulmonology
- California
  - Fresno, California, United States, 93720
    - Recruiting
    - The Medical Research Group - Saint Agnes Medical Center
  - Granada Hills, California, United States, 91344
    - Recruiting
    - Amicis Research Center - Balboa
  - Granada Hills, California, United States, 91344
    - Recruiting
    - Kidney Care Center of North Valley
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90022
    - Recruiting
    - Eastside Clinical Research Associates
  - Los Angeles, California, United States, 90095
    - Completed
    - UCLA Division of Nephrology
  - Orange, California, United States, 92868
    - Recruiting
    - UCI Center for Clinical Research
  - Sacramento, California, United States, 95825
    - Recruiting
    - Kaiser Permanente Sacramento Medical Center
  - San Francisco, California, United States, 94143
    - Recruiting
    - Helen Diller Medical Center at Parnassus Heights
  - Torrance, California, United States, 90502
    - Recruiting
    - UCLA Lundquist Institute at Harbor-UCLA Medical Center
  - Victorville, California, United States, 92395
    - Completed
    - Kidney and Hypertension Center
- Connecticut
  - Bloomfield, Connecticut, United States, 06002
    - Recruiting
    - Greater Hartford Nephrology
  - Middlebury, Connecticut, United States, 06762
    - Recruiting
    - Nephrology & Hypertension Associates, PC
  - New Haven, Connecticut, United States, 06510
    - Recruiting
    - Yale University - Yale Nephrology Clinical Research Clinic
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Recruiting
    - Children's National Hospital - Nephrology
  - Washington D.C., District of Columbia, United States, 20037
    - Recruiting
    - The George Washington University - GW Medical Faculty Associates
  - Washington D.C., District of Columbia, United States, 20422
    - Recruiting
    - Veterans Affairs Medical Center - Washington D.C
- Florida
  - Bay Pines, Florida, United States, 33744
    - Recruiting
    - Bay Pines Foundation
  - Bradenton, Florida, United States, 34209
    - Recruiting
    - Nova Clinical Research, LLC - Bradenton - 59th St
  - Brandon, Florida, United States, 33511
    - Recruiting
    - Clinical Research Of Brandon, LLC
  - Coral Gables, Florida, United States, 33134
    - Completed
    - Horizon Research Group - Coral Gables
  - Coral Gables, Florida, United States, 33134
    - Completed
    - AMR-Miami
  - Coral Springs, Florida, United States, 33071
    - Recruiting
    - South Florida Nephrology Research
  - Delray Beach, Florida, United States, 33445
    - Recruiting
    - Delray Physician Care Center
  - Gainesville, Florida, United States, 32608
    - Recruiting
    - North Florida/South Georgia Veterans Health System
  - Gainesville, Florida, United States, 32610
    - Recruiting
    - Shands Hospital - Nephrology
  - Hallandale, Florida, United States, 33009
    - Completed
    - Velocity Clinical Research - Hallandale Beach
  - Hialeah, Florida, United States, 33010
    - Completed
    - Qway Research
  - Hollywood, Florida, United States, 33024
    - Completed
    - Elixia Pines
  - Jacksonville, Florida, United States, 32209
    - Recruiting
    - UF Health Cardiovascular Center - Jacksonville
  - Lauderdale Lakes, Florida, United States, 33313
    - Recruiting
    - South Florida Research Institute
  - Miami, Florida, United States, 33126
    - Recruiting
    - Total Research Group, LLC
  - Miami, Florida, United States, 33180
    - Withdrawn
    - MedBio Trials
  - Miami, Florida, United States, 33182
    - Recruiting
    - Cordova Research Institute
  - Miami Springs, Florida, United States, 33166
    - Recruiting
    - South Florida Research
  - Orlando, Florida, United States, 32806
    - Active, not recruiting
    - CTR Oakwater, LLC
  - Orlando, Florida, United States, 32806
    - Completed
    - Synexus Clinical Research - Orlando
  - Orlando, Florida, United States, 32808
    - Recruiting
    - Omega Research Orlando, LLC - Mercy Dr
  - Sanford, Florida, United States, 32771
    - Recruiting
    - Infigo Clinical Research
  - Tampa, Florida, United States, 33603
    - Completed
    - Genesis Clinical Research
  - Tampa, Florida, United States, 33618
    - Completed
    - Elixia Tampa
- Georgia
  - Acworth, Georgia, United States, 30101
    - Recruiting
    - American Clinical Trials LLC - Acworth
  - Atlanta, Georgia, United States, 30305
    - Recruiting
    - Kaiser Permanente Georgia
  - Atlanta, Georgia, United States, 30310
    - Recruiting
    - Morehouse School of Medicine, Grady Memorial Hospital
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Fides Clinical Research
  - Atlanta, Georgia, United States, 30308
    - Recruiting
    - Emory School of Medicine - Renal Division
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Emory Childrens Center - Nephrology
  - Atlanta, Georgia, United States, 30328
    - Recruiting
    - Synexus Clinical Research - Atlanta (DRS)
  - Atlanta, Georgia, United States, 30309
    - Completed
    - Advanced Clinical Research of Atlanta
  - Augusta, Georgia, United States, 30912
    - Recruiting
    - Augusta University Medical College of Georgia - Adult Sickle Cell Clinic
  - Brunswick, Georgia, United States, 31520
    - Completed
    - Coastal Medical Research
  - College Park, Georgia, United States, 30337
    - Recruiting
    - Randomize Now - College Park
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - Clincept - Veterans Pkwy.
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - Renal Associates
  - Decatur, Georgia, United States, 30030
    - Recruiting
    - Georgia Nephrology - Decatur
  - Decatur, Georgia, United States, 30033
    - Completed
    - Atlanta VA Healthcare System
  - Douglasville, Georgia, United States, 30134
    - Recruiting
    - American Clinical Trials LLC - Douglasville
  - East Point, Georgia, United States, 30344
    - Recruiting
    - Southeast Kidney Associates
  - Fayetteville, Georgia, United States, 30214
    - Recruiting
    - Javara Inc./Privia Medical Group - Fayetteville, GA
  - Lawrenceville, Georgia, United States, 30046
    - Recruiting
    - Georgia Nephrology - Lawrenceville - Billing Office
  - Savannah, Georgia, United States, 31406
    - Recruiting
    - Javara Inc./Privia Medical Group - Savannah, GA
  - Tyrone, Georgia, United States, 30290
    - Recruiting
    - Inova Clinical Trials and Research Center
  - Union City, Georgia, United States, 30291
    - Recruiting
    - Rophe Adult and Pediatric Medicine
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Northwestern Medical Group
  - Chicago, Illinois, United States, 60608
    - Recruiting
    - EmVenio Research - Chicago
  - Chicago, Illinois, United States, 60602
    - Recruiting
    - Synexus Clinical Research - Chicago (DRS)
  - Chicago, Illinois, United States, 60611-2605
    - Recruiting
    - Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - UChicago Medicine - Comer Children's Hospital
  - Evergreen Park, Illinois, United States, 60805
    - Recruiting
    - NANI Research LLC - Evergreen Park IL
  - Hines, Illinois, United States, 60141
    - Recruiting
    - Edward Hines Jr VA Hospital
  - Palos Hills, Illinois, United States, 60465
    - Completed
    - Essential Concepts Research Solutions
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - Recruiting
    - NANI Research LLC - Fort Wayne IN
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - IU School of Medicine - Nephrology
  - Mishawaka, Indiana, United States, 46545
    - Completed
    - Nephrology Physicians, LLC
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa Health Care Medical Center- Nephrology
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Completed
    - Clinical & Translational Science Unit (CTSU) - Nephrology
  - Overland Park, Kansas, United States, 66210
    - Completed
    - Premier Clinical Research
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Recruiting
    - Renal Associates of Baton Rouge
  - Metairie, Louisiana, United States, 70006
    - Recruiting
    - LCMC Health
  - Natchitoches, Louisiana, United States, 71457
    - Completed
    - Barnum Medical Research - Bienville St
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Medical Center - New Orleans
  - New Orleans, Louisiana, United States, 70112
    - Completed
    - Louisiana Clinical and Translational Science (LA CaTS) Center
  - New Orleans, Louisiana, United States, 70112
    - Recruiting
    - University Medical Center - New Orleans - Nephrology
  - Shreveport, Louisiana, United States, 71103
    - Recruiting
    - Louisiana State University Health Shreveport
  - Shreveport, Louisiana, United States, 71101
    - Recruiting
    - Northwest Louisiana Nephrology, LLC
  - West Monroe, Louisiana, United States, 71291
    - Recruiting
    - Monroe Research, LLC
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Recruiting
    - Javara Inc./Privia Medical Group - Annapolis, MD
  - Baltimore, Maryland, United States, 21201
    - Completed
    - University of Maryland Medical Center - General Clinical Research Center
  - Baltimore, Maryland, United States, 21287
    - Recruiting
    - The Johns Hopkins University - Johns Hopkins Hospital - Nephrology
  - Gaithersburg, Maryland, United States, 20879
    - Recruiting
    - Mid-Atlantic Permanente Research Institute
  - Lutherville, Maryland, United States, 21093
    - Recruiting
    - Patient First Clinical Trials
  - Oxon Hill, Maryland, United States, 20745
    - Recruiting
    - MD Medical Research
  - Silver Spring, Maryland, United States, 20901
    - Recruiting
    - Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Recruiting
    - Boston Medical Center
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Tufts Medical Center
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center - Nephrology
  - Roxbury, Massachusetts, United States, 02120
    - Recruiting
    - Whittier Street Health Center
  - Springfield, Massachusetts, United States, 01107
    - Completed
    - Renal and Transplant Associates of New England, PC
  - West Springfield, Massachusetts, United States, 01089
    - Recruiting
    - Kidney Care and Transplant Services of New England - West Springfield
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Health System - Nephrology
  - Farmington Hills, Michigan, United States, 48334
    - Completed
    - QUEST Research Institute
  - Flint, Michigan, United States, 48504
    - Recruiting
    - AA Medical Research Center
  - Lansing, Michigan, United States, 48912
    - Recruiting
    - Sparrow Clinical Research Institute
  - Roseville, Michigan, United States, 48066
    - Completed
    - St. Clair Nephrology Research
  - Saint Clair Shores, Michigan, United States, 48081
    - Recruiting
    - Center for Advanced Kidney Research
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Completed
    - InterMed Consultants - Edina Clinic
  - Minneapolis, Minnesota, United States, 55417
    - Completed
    - Minneapolis VA Healthcare System
- Mississippi
  - Columbus, Mississippi, United States, 39705
    - Recruiting
    - Nephrology Associates, P.C. - Columbus
  - Fayette, Mississippi, United States, 39069
    - Recruiting
    - Prime Health and Wellness
  - Grenada, Mississippi, United States, 38901
    - Completed
    - UMMC Grenada Hospital
  - Jackson, Mississippi, United States, 39216
    - Completed
    - G.V. (Sonny) Montgomery VAMC
  - Olive Branch, Mississippi, United States, 38654
    - Recruiting
    - Olive Branch Family Medical Center
  - Ridgeland, Mississippi, United States, 39157
    - Recruiting
    - SKY Integrative Medical Center
  - Tupelo, Mississippi, United States, 38801
    - Recruiting
    - Nephrology and Hypertension Associates - Tupelo
- Missouri
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - St. Louis Children's Hospital - Nephrology
  - St Louis, Missouri, United States, 63136
    - Recruiting
    - St. Louis Heart and Vascular, P.C.
  - St Louis, Missouri, United States, 63104
    - Completed
    - Center for Specialized Medicine - Nephrology
  - St Louis, Missouri, United States, 63108
    - Recruiting
    - Barnes-Jewish Center for Outpatient Health
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Withdrawn
    - Nevada Kidney Disease and Hypertension Centers
  - Las Vegas, Nevada, United States, 89107
    - Recruiting
    - DaVita Kidney Care - Las Vegas
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Recruiting
    - CUH - Sheridan Pavilion - Three Cooper Plaza
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Hackensack University Medical Center
  - Hamilton, New Jersey, United States, 08690
    - Recruiting
    - Bioluminux Clinical Research New Jersey
  - Neptune City, New Jersey, United States, 07753
    - Recruiting
    - Jersey Shore University Medical Center
  - Newark, New Jersey, United States, 07103
    - Recruiting
    - Rutgers Doctors Office Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Completed
    - Renal Medicine Associates
  - Albuquerque, New Mexico, United States, 87108
    - Completed
    - New Mexico VA Healthcare System
- New York
  - Brooklyn, New York, United States, 11203
    - Recruiting
    - SUNY Downstate Health Sciences University
  - Brooklyn, New York, United States, 11203
    - Recruiting
    - Kings County Hospital
  - Brooklyn, New York, United States, 11221
    - Completed
    - Clindove Research LLC
  - Flushing, New York, United States, 11365
    - Recruiting
    - New York Presbyterian Queens
  - Great Neck, New York, United States, 11021
    - Recruiting
    - Zucker School of Medicine
  - Laurelton, New York, United States, 11413
    - Recruiting
    - Scott Research, Inc.
  - New York, New York, United States, 10037
    - Recruiting
    - NYC Health + Hospital/Harlem
  - New York, New York, United States, 10016
    - Recruiting
    - Grossman School of Medicine
  - New York, New York, United States, 10017
    - Completed
    - Synexus Clinical Research - New York (DRS)
  - New York, New York, United States, 10021
    - Recruiting
    - The Rogosin Kidney Center
  - New York, New York, United States, 10029
    - Recruiting
    - Icahn School of Medicine at Mount Sinai - Nephrology
  - New York, New York, United States, 10032
    - Recruiting
    - General Nephrology Clinic - New York City
  - New York, New York, United States, 10010
    - Completed
    - VA New York Harbor Healthcare System
  - The Bronx, New York, United States, 10468
    - Recruiting
    - James J. Peters VA Medical Center
  - The Bronx, New York, United States, 10461
    - Completed
    - Kidney Medical Associates, PLLC
  - The Bronx, New York, United States, 10461
    - Recruiting
    - Montefiore Einstein - Albert Einstein College of Medicine
  - The Bronx, New York, United States, 10467
    - Recruiting
    - Montefiore Einstein Hospital - Moses Campus
- North Carolina
  - Cary, North Carolina, United States, 27511
    - Recruiting
    - North Carolina Nephrology P.A. - Cary
  - Chapel Hill, North Carolina, United States, 27599-7155
    - Recruiting
    - UNC Clinical and Translational Research Center
  - Charlotte, North Carolina, United States, 28208
    - Recruiting
    - Metrolina Nephrology Associates - Freedom Dr
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Hospital - Children's Health Center
  - Greenville, North Carolina, United States, 27834
    - Recruiting
    - Eastern Nephrology Associates - Greenville Office
  - Jacksonville, North Carolina, United States, 28546
    - Recruiting
    - Eastern Nephrology Associates - Jacksonville Office
  - Kinston, North Carolina, United States, 28504
    - Recruiting
    - Eastern Nephrology Associates - Kinston Office
  - New Bern, North Carolina, United States, 28562
    - Recruiting
    - Eastern Nephrology Associates - New Bern Office
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - Eastern Nephrology Associates - Wilmington Office
  - Winston-Salem, North Carolina, United States, 27103
    - Completed
    - Brookview Hills Research Associates
- Ohio
  - Cincinnati, Ohio, United States, 45220
    - Completed
    - Cincinnati VA Medical Center
  - Cincinnati, Ohio, United States, 45206
    - Recruiting
    - UC - DCI McMillan Research Unit
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - Louis Stokes Cleveland VA Medical Center
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic - Main Campus
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - UH Cleveland Medical Center - Nephrology
  - Columbus, Ohio, United States, 43201
    - Recruiting
    - Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Recruiting
    - Lewis Katz School of Medicine at Temple University - Section of Nephrology
  - Philadelphia, Pennsylvania, United States, 19141
    - Recruiting
    - Jefferson Einstein Philadelphia Hospital - Nephrology
  - Philadelphia, Pennsylvania, United States, 19107
    - Completed
    - Jefferson Health - 33 South 9th Street
  - Pittsburgh, Pennsylvania, United States, 15224
    - Active, not recruiting
    - Children's Hospital of Pittsburgh - Nephrology
- Rhode Island
  - East Providence, Rhode Island, United States, 02915
    - Recruiting
    - Lifespan Clinical Research Center
- South Carolina
  - Charleston, South Carolina, United States, 29412
    - Recruiting
    - Pharmacorp Clinical Trials, Inc
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina - Pulmonology
  - Columbia, South Carolina, United States, 29203
    - Recruiting
    - Columbia Nephrology Associates, PA
  - Spartanburg, South Carolina, United States, 29306
    - Recruiting
    - Carolina Nephrology, PA
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Recruiting
    - Southeast Renal Research Institute
  - Memphis, Tennessee, United States, 38119
    - Recruiting
    - CNS Healthcare - Memphis
  - Memphis, Tennessee, United States, 38105
    - Recruiting
    - Le Bonheur Children's Hospital - Outpatient Clinic
  - Nashville, Tennessee, United States, 37212
    - Recruiting
    - Nashville VA Medical Center
  - Nashville, Tennessee, United States, 37208
    - Recruiting
    - Nashville General Hospital - Meharry Medical College - Nephrology
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Nephrology Clinical Trials Center
- Texas
  - Arlington, Texas, United States, 76015
    - Completed
    - Arlington Nephrology
  - Arlington, Texas, United States, 76002
    - Completed
    - Dallas Renal Group - Mansfield
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Zenos Clinical Research
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Dallas Nephrology Associates - Dallas Landry Office
  - Dallas, Texas, United States, 75325
    - Recruiting
    - Southwest Family Medicine Associates (SFMA) - Dallas
  - Dallas, Texas, United States, 75204
    - Recruiting
    - Baylor Scott and White Research Institute - Nephrology
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Dallas Renal Group- Dallas
  - Dallas, Texas, United States, 75231
    - Completed
    - Nephrotex Research Group
  - Dallas, Texas, United States, 75237
    - Recruiting
    - Dallas Renal Group - Liberty Dallas Dialysis Center
  - Dallas, Texas, United States, 75390
    - Recruiting
    - UTSW Medical Center - Nephrology
  - El Paso, Texas, United States, 79925
    - Recruiting
    - Davita Clinical Research - El Paso
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Cook Children's Medical Center
  - Houston, Texas, United States, 77074
    - Completed
    - Houston Medical Research Institute, LLC
  - Houston, Texas, United States, 77090
    - Completed
    - Clinical Research Strategies - Romano North Main Office
  - Houston, Texas, United States, 77054
    - Recruiting
    - Ronald Ralph MD PA
  - Houston, Texas, United States, 77054
    - Recruiting
    - Prolato Clinical Research Center - Kirby Dr
  - Houston, Texas, United States, 77099
    - Completed
    - Frenova-Southwest Houston
  - Lewisville, Texas, United States, 75067
    - Recruiting
    - Prime Clinical Research Inc - Lewisville
  - Lewisville, Texas, United States, 75057
    - Completed
    - NTKDA Lewisville
  - Lubbock, Texas, United States, 79430
    - Recruiting
    - Texas Tech University Health Sciences Center
  - Mansfield, Texas, United States, 76063
    - Recruiting
    - Prime Clinical Research - Mansfield - Regency Parkway
  - San Antonio, Texas, United States, 78229
    - Withdrawn
    - San Antonio Kidney Disease Center Physicians Group - Medical Center
  - San Antonio, Texas, United States, 78229
    - Completed
    - University of Texas Health Science Center - Nephrology
  - San Antonio, Texas, United States, 78251
    - Completed
    - San Antonio Kidney Disease Center Physicians Group - Westover Hills
  - Shenandoah, Texas, United States, 77384
    - Recruiting
    - Kidney Specialists of N Houston, PLLC
  - The Woodlands, Texas, United States, 77384
    - Recruiting
    - Renal Research of Montgomery County, PLLC
  - Webster, Texas, United States, 77598
    - Recruiting
    - Tranquil Clinical Research
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - UVA Health - Nephrology Clinical Research Center
  - Norfolk, Virginia, United States, 23504
    - Completed
    - York Clinical Research, LLC
  - Norfolk, Virginia, United States, 23504
    - Recruiting
    - Tidewater Kidney Specialists - Church St.
  - Richmond, Virginia, United States, 23298
    - Recruiting
    - Virginia Commonwealth University - Division of Nephrology
  - Richmond, Virginia, United States, 23249
    - Recruiting
    - McGuire Research Institute, Inc. (151)
  - Virginia Beach, Virginia, United States, 23454
    - Completed
    - Nephrology Associates of Tidewater, LTD
- Washington
  - Seattle, Washington, United States, 98195
    - Recruiting
    - UW Medical Center - Montlake - Nephrology
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Medical College of Wisconsin - Pulmonology
  - Wauwatosa, Wisconsin, United States, 53226
    - Recruiting
    - Milwaukee Nephrologists - Wauwatosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Part A:

APOL1 genotype of G1/G1, G2/G2, or G1/G2
Proteinuric kidney disease

Part B:

- Completion of Treatment Period in Part A and no permanent discontinuation of study drug.

Key Exclusion Criteria:

Part A:

Solid organ or bone marrow transplant
Uncontrolled hypertension
History of diabetes mellitus
Known underlying cause of kidney disease including but not limited to sickle cell disease

Part B:

ESKD (End Stage Kidney Disease) as defined in the protocol.
Any lab abnormality that may pose a safety risk to the participant, as judged by the investigator.

Other protocol defined Inclusion/Exclusion criteria will apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Sequential Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (Phase 2/3): VX-147 Participants will be randomized to receive different doses of VX-147. Participants will receive the selected dose of VX-147 for atleast 96 weeks.	Drug: VX-147 Tablets for oral administration.
Placebo Comparator: Part A (Phase 2/3): Placebo Participants will receive placebo matched to VX-147.	Drug: Placebo Tablets for oral administration.
Experimental: Part B (Phase 3): VX-147 Participants who complete Part A will receive VX-147 for an additional 96 weeks.	Drug: VX-147 Tablets for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis) Time Frame: From Baseline to Week 48	From Baseline to Week 48
Part A: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at Interim Analysis Time Frame: From Baseline Through >= Week 48	From Baseline Through >= Week 48
Part A: eGFR Slope Assessed at Final Analysis Time Frame: From Baseline Through Study Completion (At least 2 years of eGFR data assessed at the final analysis)	From Baseline Through Study Completion (At least 2 years of eGFR data assessed at the final analysis)
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) Time Frame: Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)	Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)

Secondary Outcome Measures

Outcome Measure	Time Frame
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) Time Frame: Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)	Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
Part A: Maximum Plasma Concentration (Cmax) of VX-147 Time Frame: Day 1 and Week 40	Day 1 and Week 40
Part A: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147 Time Frame: Day 1 and Week 40	Day 1 and Week 40
Part A: Observed Pre-dose Plasma Concentration (Ctrough) of VX-147 Time Frame: Day 1 up to Week 40	Day 1 up to Week 40
Part A: Acceptability Tablet Formulation of VX-147 in Pediatric Participants using the Convenience Domain of the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 Time Frame: Day 1 and Week 48	Day 1 and Week 48
Part B: Percent Change From Baseline in UPCR Over Time Time Frame: From Baseline Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)	From Baseline Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)
Part B: eGFR Slope Assessment Time Frame: Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)	Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2022

Primary Completion (Estimated)

June 2, 2028

Study Completion (Estimated)

May 7, 2030

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

APOL1-mediated kidney disease (AMKD)

Additional Relevant MeSH Terms

Other Study ID Numbers

VX21-147-301
2024-515633-15-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Proteinuric Kidney Disease

Clinical Trials on VX-147

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