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AzTrials

Proteinuric Kidney DiseasePhase 2/3AMPLITUDENCT05312879

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

A Phase 2/3 study testing VX-147 in people with Proteinuric Kidney Disease, run by Vertex Pharmaceuticals Incorporated at 314 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 65 years
Conditions the study is for
Proteinuric Kidney Disease
What is being tested?
VX-147
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
522 participants
Where
314 sitesin 13 countries
Study dates
30 Mar 2022to 7 May 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 9Show fewer
  • 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.

Trial locations and contacts

314 sites in 13 countries.

314 sites in 13 countries

United States223 sites

  • American Clinical Trials LLC - Acworth

    Acworth, Georgia, 30101

  • Alabama Kidney Research

    Alabaster, Alabama, 35007

  • New Mexico VA Healthcare System

    Albuquerque, New Mexico, 87108

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

  • A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center

    Ann Arbor, Michigan, 48109

  • Javara Inc./Privia Medical Group - Annapolis, MD

    Annapolis, Maryland, 21401

  • Dallas Renal Group - Mansfield

    Arlington, Texas, 76002

  • Arlington Nephrology

    Arlington, Texas, 76015

  • Kaiser Permanente Georgia

    Atlanta, Georgia, 30305

  • Emory School of Medicine - Renal Division

    Atlanta, Georgia, 30308

  • Advanced Clinical Research of Atlanta

    Atlanta, Georgia, 30309

  • Morehouse School of Medicine, Grady Memorial Hospital

    Atlanta, Georgia, 30310

  • Emory Childrens Center - Nephrology

    Atlanta, Georgia, 30322

  • Synexus Clinical Research - Atlanta (DRS)

    Atlanta, Georgia, 30328

  • Fides Clinical Research

    Atlanta, Georgia, 30342

  • Augusta University Medical College of Georgia - Adult Sickle Cell Clinic

    Augusta, Georgia, 30912

  • University of Maryland Medical Center - General Clinical Research Center

    Baltimore, Maryland, 21201

  • The Johns Hopkins University - Johns Hopkins Hospital - Nephrology

    Baltimore, Maryland, 21287

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana, 70808

  • Bay Pines Foundation

    Bay Pines, Florida, 33744

  • EmVenio Research - Mobile Unit - Birmingham

    Birmingham, Alabama, 35210

  • Cardiology, P.C.

    Birmingham, Alabama, 35211

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

  • The Kirklin Clinic - Nephrology

    Birmingham, Alabama, 35294

  • Greater Hartford Nephrology

    Bloomfield, Connecticut, 06002

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center - Nephrology

    Boston, Massachusetts, 02215

  • Nova Clinical Research, LLC - Bradenton - 59th St

    Bradenton, Florida, 34209

  • Clinical Research of Brandon, LLC

    Brandon, Florida, 33511

  • Kings County Hospital

    Brooklyn, New York, 11203

  • SUNY Downstate Health Sciences University

    Brooklyn, New York, 11203

  • Clindove Research LLC

    Brooklyn, New York, 11221

  • Coastal Medical Research

    Brunswick, Georgia, 31520

  • CUH - Sheridan Pavilion - Three Cooper Plaza

    Camden, New Jersey, 08103

  • North Carolina Nephrology P.A. - Cary

    Cary, North Carolina, 27511

  • UNC Clinical and Translational Research Center

    Chapel Hill, North Carolina, 27599-7155

  • Pharmacorp Clinical Trials, Inc

    Charleston, South Carolina, 29412

  • Medical University of South Carolina - Pulmonology

    Charleston, South Carolina, 29425

  • Metrolina Nephrology Associates - Freedom Dr

    Charlotte, North Carolina, 28208

  • UVA Health - Nephrology Clinical Research Center

    Charlottesville, Virginia, 22908

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37404

  • Synexus Clinical Research - Chicago (DRS)

    Chicago, Illinois, 60602

  • EmVenio Research - Chicago

    Chicago, Illinois, 60608

  • Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology

    Chicago, Illinois, 60611-2605

  • Northwestern Medical Group

    Chicago, Illinois, 60611

  • UChicago Medicine - Comer Children's Hospital

    Chicago, Illinois, 60637

  • UC - DCI McMillan Research Unit

    Cincinnati, Ohio, 45206

  • Cincinnati VA Medical Center

    Cincinnati, Ohio, 45220

  • Louis Stokes Cleveland VA medical Center

    Cleveland, Ohio, 44106

  • UH Cleveland Medical Center - Nephrology

    Cleveland, Ohio, 44106

  • Cleveland Clinic - Main Campus

    Cleveland, Ohio, 44195

  • Randomize Now - College Park

    College Park, Georgia, 30337

  • Columbia Nephrology Associates, PA

    Columbia, South Carolina, 29203

  • Clincept - Veterans Pkwy.

    Columbus, Georgia, 31904

  • Renal Associates

    Columbus, Georgia, 31904

  • Nephrology Associates, P.C. - Columbus

    Columbus, Mississippi, 39705

  • Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit

    Columbus, Ohio, 43201

  • AMR-Miami

    Coral Gables, Florida, 33134

  • Horizon Research Group - Coral Gables

    Coral Gables, Florida, 33134

  • South Florida Nephrology Research

    Coral Springs, Florida, 33071

  • Baylor Scott and White Research Institute - Nephrology

    Dallas, Texas, 75204

  • Dallas Renal Group- Dallas

    Dallas, Texas, 75230

  • Zenos Clinical Research

    Dallas, Texas, 75230

  • Nephrotex Research Group

    Dallas, Texas, 75231

  • Dallas Renal Group - Liberty Dallas Dialysis Center

    Dallas, Texas, 75237

  • Dallas Nephrology Associates - Dallas Landry Office

    Dallas, Texas, 75246

  • Southwest Family Medicine Associates (SFMA) - Dallas

    Dallas, Texas, 75325

  • UTSW Medical Center - Nephrology

    Dallas, Texas, 75390

  • Georgia Nephrology - Decatur

    Decatur, Georgia, 30030

  • Atlanta VA Healthcare System

    Decatur, Georgia, 30033

  • Delray Physician Care Center

    Delray Beach, Florida, 33445

  • Henry Ford Health System - Nephrology

    Detroit, Michigan, 48202

  • American Clinical Trials LLC - Douglasville

    Douglasville, Georgia, 30134

  • Duke University Hospital - Children's Health Center

    Durham, North Carolina, 27710

  • Southeast Kidney Associates

    East Point, Georgia, 30344

  • Lifespan Clinical Research Center

    East Providence, Rhode Island, 02915

  • InterMed Consultants - Edina Clinic

    Edina, Minnesota, 55435

  • Davita Clinical Research - El Paso

    El Paso, Texas, 79925

  • NANI Research LLC - Evergreen Park IL

    Evergreen Park, Illinois, 60805

  • Nephrology Associates

    Fairhope, Alabama, 36532

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Prime Health and Wellness

    Fayette, Mississippi, 39069

  • Javara Inc./Privia Medical Group - Fayetteville, GA

    Fayetteville, Georgia, 30214

  • AA Medical Research Center

    Flint, Michigan, 48504

  • New York Presbyterian Queens

    Flushing, New York, 11365

  • NANI Research LLC - Fort Wayne IN

    Fort Wayne, Indiana, 46804

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • The Medical Research Group - Saint Agnes Medical Center

    Fresno, California, 93720

  • North Florida/South Georgia Veterans Health System

    Gainesville, Florida, 32608

  • Shands Hospital - Nephrology

    Gainesville, Florida, 32610

  • Mid-Atlantic Permanente Research Institute

    Gaithersburg, Maryland, 20879

  • Amicis Research Center - Balboa

    Granada Hills, California, 91344

  • Kidney Care Center of North Valley

    Granada Hills, California, 91344

  • Zucker School of Medicine

    Great Neck, New York, 11021

  • Eastern Nephrology Associates - Greenville Office

    Greenville, North Carolina, 27834

  • UMMC Grenada Hospital

    Grenada, Mississippi, 38901

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Velocity Clinical Research - Hallandale Beach

    Hallandale, Florida, 33009

  • Bioluminux Clinical Research New Jersey

    Hamilton, New Jersey, 08690

  • Qway Research

    Hialeah, Florida, 33010

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141

  • Elixia Pines

    Hollywood, Florida, 33024

  • Prolato Clinical Research Center - Kirby Dr

    Houston, Texas, 77054

  • Ronald Ralph MD PA

    Houston, Texas, 77054

  • Houston Medical Research Institute, LLC

    Houston, Texas, 77074

  • Clinical Research Strategies - Romano North Main Office

    Houston, Texas, 77090

  • Frenova-Southwest Houston

    Houston, Texas, 77099

  • Heart Center Research LLC

    Huntsville, Alabama, 35801

  • Nephrology Consultants, LLC

    Huntsville, Alabama, 35805

  • IU School of Medicine - Nephrology

    Indianapolis, Indiana, 46202

  • University of Iowa Health Care Medical Center- Nephrology

    Iowa City, Iowa, 52242

  • G.V. (Sonny) Montgomery VAMC

    Jackson, Mississippi, 39216

  • UF Health Cardiovascular Center - Jacksonville

    Jacksonville, Florida, 32209

  • Eastern Nephrology Associates - Jacksonville Office

    Jacksonville, North Carolina, 28546

  • Clinical & Translational Science Unit (CTSU) - Nephrology

    Kansas City, Kansas, 66160

  • Eastern Nephrology Associates - Kinston Office

    Kinston, North Carolina, 28504

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • DaVita Kidney Care - Las Vegas

    Las Vegas, Nevada, 89107

  • South Florida Research Institute

    Lauderdale Lakes, Florida, 33313

  • Scott Research, Inc.

    Laurelton, New York, 11413

  • Georgia Nephrology - Lawrenceville - Billing Office

    Lawrenceville, Georgia, 30046

  • NTKDA Lewisville

    Lewisville, Texas, 75057

  • Prime Clinical Research Inc - Lewisville

    Lewisville, Texas, 75067

  • CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock

    Little Rock, Arkansas, 72204

  • UAMS Medical Center - Pulmonology

    Little Rock, Arkansas, 72205

  • Eastside Clinical Research Associates

    Los Angeles, California, 90022

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA Division of Nephrology

    Los Angeles, California, 90095

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Patient First Clinical Trials

    Lutherville, Maryland, 21093

  • Prime Clinical Research - Mansfield - Regency Parkway

    Mansfield, Texas, 76063

  • Le Bonheur Children's Hospital - Outpatient Clinic

    Memphis, Tennessee, 38105

  • CNS Healthcare - Memphis

    Memphis, Tennessee, 38119

  • LCMC Health

    Metairie, Louisiana, 70006

  • Total Research Group, LLC

    Miami, Florida, 33126

  • Cordova Research Institute

    Miami, Florida, 33182

  • South Florida Research

    Miami Springs, Florida, 33166

  • Nephrology & Hypertension Associates, PC

    Middlebury, Connecticut, 06762

  • Medical College of Wisconsin - Pulmonology

    Milwaukee, Wisconsin, 53226

  • Minneapolis VA Healthcare System

    Minneapolis, Minnesota, 55417

  • Nephrology Physicians, LLC

    Mishawaka, Indiana, 46545

  • Renal Associates of Alabama, LLC

    Montgomery, Alabama, 36117

  • Nashville General Hospital - Meharry Medical College - Nephrology

    Nashville, Tennessee, 37208

  • Nashville VA Medical Center

    Nashville, Tennessee, 37212

  • Nephrology Clinical Trials Center

    Nashville, Tennessee, 37232

  • Barnum Medical Research - Bienville St

    Natchitoches, Louisiana, 71457

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Eastern Nephrology Associates - New Bern Office

    New Bern, North Carolina, 28562

  • Yale University - Yale Nephrology Clinical Research Clinic

    New Haven, Connecticut, 06510

  • Louisiana Clinical and Translational Science (LA CaTS) Center

    New Orleans, Louisiana, 70112

  • University Medical Center - New Orleans - Nephrology

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center - New Orleans

    New Orleans, Louisiana, 70121

  • VA New York Harbor Healthcare System

    New York, New York, 10010

  • Grossman School of Medicine

    New York, New York, 10016

  • Synexus Clinical Research - New York (DRS)

    New York, New York, 10017

  • The Rogosin Kidney Center

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai - Nephrology

    New York, New York, 10029

  • General Nephrology Clinic - New York City

    New York, New York, 10032

  • NYC Health + Hospital/Harlem

    New York, New York, 10037

  • Rutgers Doctors Office Center

    Newark, New Jersey, 07103

  • Tidewater Kidney Specialists - Church St.

    Norfolk, Virginia, 23504

  • York Clinical Research, LLC

    Norfolk, Virginia, 23504

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • UCI Center for Clinical Research

    Orange, California, 92868

  • CTR Oakwater, LLC

    Orlando, Florida, 32806

  • Synexus Clinical Research - Orlando

    Orlando, Florida, 32806

  • Omega Research Orlando, LLC - Mercy Dr

    Orlando, Florida, 32808

  • Premier Clinical Research

    Overland Park, Kansas, 66210

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Essential Concepts Research Solutions

    Palos Hills, Illinois, 60465

  • Jefferson Health - 33 South 9th Street

    Philadelphia, Pennsylvania, 19107

  • Lewis Katz School of Medicine at Temple University - Section of Nephrology

    Philadelphia, Pennsylvania, 19140

  • Jefferson Einstein Philadelphia Hospital - Nephrology

    Philadelphia, Pennsylvania, 19141

  • Arizona Kidney Disease and Hypertension Center - Thomas Office

    Phoenix, Arizona, 85016

  • Phoenix Children's Hospital, Inc. - Nephrology

    Phoenix, Arizona, 85016

  • Children's Hospital of Pittsburgh - Nephrology

    Pittsburgh, Pennsylvania, 15224

  • McGuire Research Institute, Inc. (151)

    Richmond, Virginia, 23249

  • Virginia Commonwealth University - Division of Nephrology

    Richmond, Virginia, 23298

  • SKY Integrative Medical Center

    Ridgeland, Mississippi, 39157

  • St. Clair Nephrology Research

    Roseville, Michigan, 48066

  • Whittier Street Health Center

    Roxbury, Massachusetts, 02120

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • Center for Advanced Kidney Research

    Saint Clair Shores, Michigan, 48081

  • University of Texas Health Science Center - Nephrology

    San Antonio, Texas, 78229

  • San Antonio Kidney Disease Center Physicians Group - Westover Hills

    San Antonio, Texas, 78251

  • Helen Diller Medical Center at Parnassus Heights

    San Francisco, California, 94143

  • Infigo Clinical Research

    Sanford, Florida, 32771

  • Javara Inc./Privia Medical Group - Savannah, GA

    Savannah, Georgia, 31406

  • UW Medical Center - Montlake - Nephrology

    Seattle, Washington, 98195

  • Kidney Specialists of N Houston, PLLC

    Shenandoah, Texas, 77384

  • Northwest Louisiana Nephrology, LLC

    Shreveport, Louisiana, 71101

  • Louisiana State University Health Shreveport

    Shreveport, Louisiana, 71103

  • Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike

    Silver Spring, Maryland, 20901

  • Carolina Nephrology, PA

    Spartanburg, South Carolina, 29306

  • Renal and Transplant Associates of New England, PC

    Springfield, Massachusetts, 01107

  • Center for Specialized Medicine - Nephrology

    St Louis, Missouri, 63104

  • Barnes-Jewish Center for Outpatient Health

    St Louis, Missouri, 63108

  • St. Louis Children's Hospital - Nephrology

    St Louis, Missouri, 63110

  • St. Louis Heart and Vascular, P.C.

    St Louis, Missouri, 63136

  • Genesis Clinical Research

    Tampa, Florida, 33603

  • Elixia Tampa

    Tampa, Florida, 33618

  • Kidney Medical Associates, PLLC

    The Bronx, New York, 10461

  • Montefiore Einstein - Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Montefiore Einstein Hospital - Moses Campus

    The Bronx, New York, 10467

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468

  • Renal Research of Montgomery County, PLLC

    The Woodlands, Texas, 77384

  • UCLA Lundquist Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Nephrology and Hypertension Associates - Tupelo

    Tupelo, Mississippi, 38801

  • Inova Clinical Trials and Research Center

    Tyrone, Georgia, 30290

  • Rophe Adult and Pediatric Medicine

    Union City, Georgia, 30291

  • Kidney and Hypertension Center

    Victorville, California, 92395

  • Nephrology Associates of Tidewater, LTD

    Virginia Beach, Virginia, 23454

  • Children's National Hospital - Nephrology

    Washington D.C., District of Columbia, 20010

  • The George Washington University - GW Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Veterans Affairs Medical Center - Washington D.C

    Washington D.C., District of Columbia, 20422

  • Milwaukee Nephrologists - Wauwatosa

    Wauwatosa, Wisconsin, 53226

  • Tranquil Clinical Research

    Webster, Texas, 77598

  • Monroe Research, LLC

    West Monroe, Louisiana, 71291

  • Kidney Care and Transplant Services of New England - West Springfield

    West Springfield, Massachusetts, 01089

  • Eastern Nephrology Associates - Wilmington Office

    Wilmington, North Carolina, 28401

  • Brookview Hills Research Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Brazil29 sites

  • Centro de Pesquisa Clinica do Coracao

    Aracaju

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte

  • Faculdade de Medicina de Botucatu - CKD and Hypertension Department

    Botucatu

  • Faculdade de Medicina de Botucatu - Kidney Transplantation Department

    Botucatu

  • IPECC - Instituto de Pesquisa Clinica de Campinas

    Campinas

  • Instituto Pro-Renal

    Curitiba

  • PUC Trials - Unidade Epicenter

    Curitiba

  • Instituto de Ensino e Pesquisa Clinica do Ceara

    Fortaleza

  • Walter Cantídio University Hospital

    Fortaleza

  • Federal University of Goiás (UFG)

    Goiânia

  • Cmip-Centro Mineiro de Pesquisa Ltda

    Juiz de Fora

  • Galileo Medical Research Ltda

    Juiz de Fora

  • ICM - Instituto do Coracao de Marilia

    Marília

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

    Monte Alegre

  • Dom Vicente Scherer Hospital

    Porto Alegre

  • Hospital de Clínicas de Porto Alegre - Nephrology

    Porto Alegre

  • Centro de Pesquisa Clinica Professor Salomao Kelner

    Recife

  • Hospital São Lucas

    Rio de Janeiro

  • Hospital Universitario Pedro Ernesto - Departamento de Nefrologia

    Rio de Janeiro

  • Hospital Universitario Pedro Ernesto - Departamento de Patologia

    Rio de Janeiro

  • Comlexo Hospitalar Universitário Professor Edgard Santos

    Salvador

  • CSB Group of Nephrology Brazil

    Salvador

  • Hospital Ana Nery/SESAB

    Salvador

  • Praxis Pesquisa Medica

    Santo André

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto

  • Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular

    São Paulo

  • Hospital do Rim - Fundação Oswaldo Ramos

    São Paulo

  • Hospital Nove de Julho - Nephrology

    São Paulo

  • Irmandade Da Santa Casa De Misericordia De Sao Paulo

    São Paulo

Other trials in Brazil

United Kingdom18 sites

  • Mid and South Essex Hospitals NHS Trust

    Basildon

  • Synexus Clinical Research - Glasgow (DRS)

    Bellshill

  • FutureMeds Birmingham

    Birmingham

  • Queen Elizabeth Hospital Birmingham

    Birmingham

  • Synexus Clinical Research - Midlands (DRS)

    Birmingham

  • Epsom and St Helier University Hospitals NHS Trust

    Carshalton

  • Leicester General Hospital

    Leicester

  • Great Ormond Street Hospital for Children

    London

  • Guy's Hospital - Endocrinology

    London

  • King's College Hospital - Pulmonology

    London

  • Royal Free Hospital - Nephrology

    London

  • St George's Hospital London - Nephrology

    London

  • St Pancras Clinical Research

    London

  • The Royal London Hospital - Nephrology

    London

  • Manchester Royal Infirmary - Endocrinology

    Manchester

  • Synexus Clinical Research - NW Consortium Manchester (DRS)

    Manchester

  • Wythenshawe Hospital - Medicines Evaluation Unit

    Manchester

  • Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology

    Nottingham

Other trials in United Kingdom

France12 sites

  • Hopital Henri Mondor - Nephrology

    Créteil

  • Hospital Nord Michallon - Nephrology

    Grenoble

  • Bicetre Hospital

    Le Kremlin-Bicêtre

  • CHU Dupuytren 2 - Néphrologie, dialyse, transplantations

    Limoges

  • Hôpital de la Conception

    Marseille

  • Ambroise Paré Hospital

    Paris

  • Hopital Necker Enfants Malades - Nephrology

    Paris

  • Hopital Tenon

    Paris

  • Université Paris-Descartes / Hôpital Européen Georges Pompidou

    Paris

  • CHU de Guadeloupe

    Pointe à Pitre

  • AURA Nord

    Saint-Ouen

  • Hopital de Rangueil

    Toulouse

Other trials in France

Colombia7 sites

  • Clinica de La Costa S.A.S

    Atlántico

  • Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO

    Bogotá

  • Fundación Valle Del Lili

    Cali

  • Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS

    Cartagena

  • Mediservis del Tolima IPS S.A.S.

    Ibague

  • Fundación Hospitalaria San Vicente de Paul

    Medellín

  • Promotora Medica Las Americas S.A. - Clinica Las Americas

    Medellín

Other trials in Colombia

Nigeria5 sites

  • University of Nigeria Teaching Hospital

    Enugu

  • University College Hospital

    Ibadan

  • Lagos University Teaching Hospital

    Idi-Araba

  • Lagos State University Teaching Hospital

    Ikeja

  • Nigerian Institute of Medical Research

    Lagos

Other trials in Nigeria

Spain5 sites

  • Hospital Clinic de Barcelona - Nephrology

    Barcelona

  • Hospital Universitari Vall d´Hebron - Servicio de Pediatria

    Barcelona

  • Reina Sofia University Hospital - Nephrology

    Córdoba

  • Hospital Universitario 12 de Octubre - Nephrology

    Madrid

  • Hospital Universitario Virgen Macarena

    Seville

Other trials in Spain

Portugal4 sites

  • Unidade Local de Saude Amadora/Sintra, E.P.E.

    Amadora

  • Hospital Curry Cabral - Serviço de Nefrologia

    Lisbon

  • Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology

    Lisbon

  • Unidade Local de Saúde de Loures-Odivelas, E.P.E.

    Loures

Other trials in Portugal

Ghana3 sites

  • University of Ghana Medical School - Nephrology

    Accra

  • The Bank Hospital

    Cantonments

  • Komfo Anokye Teaching Hospital - Nephrology

    Kumasi

Other trials in Ghana

Puerto Rico3 sites

  • FDI Clinical Research

    Mayagüez, 06680

  • University of Puerto Rico

    Rio Piedras, 00935

  • GCM Medical Group, PSC

    San Juan, 00917

Other trials in Puerto Rico

Belgium2 sites

  • Universite Catholique de Louvain - Nephrology

    Brussels

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology

    Leuven

Other trials in Belgium

Canada2 sites

  • Recherche GCP Research

    Montreal

  • Women's College Hospital

    Toronto

Other trials in Canada

Netherlands1 site

  • Amsterdam UMC - Amsterdam Public Health Research Institute

    Amsterdam

Other trials in Netherlands

About this study

Official title: 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.

Being tested
VX-147, Placebo
Keywords
APOL1-mediated kidney disease (AMKD)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VX-147Drug

    Tablets for oral administration.

  • PlaceboDrug

    Tablets for oral administration.

Study groups in NCT05312879
Study groupRoleWhat they receive
Part A (Phase 2/3): VX-147ExperimentalParticipants will be randomized to receive different doses of VX-147. Participants will receive the selected dose of VX-147 for atleast 96 weeks.
Receives: Drug: VX-147
Part A (Phase 2/3): PlaceboPlacebo comparatorParticipants will receive placebo matched to VX-147.
Receives: Drug: Placebo
Part B (Phase 3): VX-147ExperimentalParticipants who complete Part A will receive VX-147 for an additional 96 weeks.
Receives: Drug: VX-147

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)

    Measured: From Baseline to Week 48

  2. Part A: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at Interim Analysis

    Measured: From Baseline Through >= Week 48

  3. Part A: eGFR Slope Assessed at Final Analysis

    Measured: From Baseline Through Study Completion (At least 2 years of eGFR data assessed at the final analysis)

  4. Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)

    Measured: Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)

Secondary outcomes (7)

  1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)

    Measured: Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)

  2. Part A: Maximum Plasma Concentration (Cmax) of VX-147

    Measured: Day 1 and Week 40

  3. Part A: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147

    Measured: Day 1 and Week 40

  4. Part A: Observed Pre-dose Plasma Concentration (Ctrough) of VX-147

    Measured: Day 1 up to Week 40

  5. 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

    Measured: Day 1 and Week 48

  6. Part B: Percent Change From Baseline in UPCR Over Time

    Measured: From Baseline Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)

  7. Part B: eGFR Slope Assessment

    Measured: Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start30 Mar 2022
  3. Primary completion2 Jun 2028 (estimated)
  4. Study completion7 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312879
Sponsor's protocol ID
VX21-147-301
Other IDs
2024-515633-15-00
Acronym
AMPLITUDE
Status last verified
Oct 2026
First submitted
28 Mar 2022
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing VX-147 in people with Proteinuric Kidney Disease, run by Vertex Pharmaceuticals Incorporated at 314 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 314 sites in United States, Brazil, United Kingdom, France, Colombia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05312879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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