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Recruiting Phase 2/3 NCT05312879

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

Phase 2/3 – combined trial
Conditions: Proteinuric Kidney Disease

Sponsor: Vertex Pharmaceuticals Incorporated

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
VX-147
DRUG
Placebo
DRUG
Locations 318
Belgium (2)
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology
Leuven
Universite Catholique de Louvain - Pulmonology
Woluwe-Saint-Lambert , Brussels Capital
Brazil (29)
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
COMPLETED
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
COMPLETED
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
TERMINATED
Hospital de Clínicas de Porto Alegre - Nephrology
Porto Alegre
COMPLETED
Centro de Pesquisa Clinica Professor Salomao Kelner
Recife
Hospital São Lucas
Rio de Janeiro
COMPLETED
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
COMPLETED
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
Canada (2)
Recherche GCP Research
Montreal
COMPLETED
Women's College Hospital
Toronto
Colombia (7)
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
France (12)
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
COMPLETED
Université Paris-Descartes / Hôpital Européen Georges Pompidou
Paris
COMPLETED
CHU de Guadeloupe
Pointe à Pitre
AURA Nord
Saint-Ouen
Hopital de Rangueil
Toulouse
COMPLETED
Ghana (3)
University of Ghana Medical School - Nephrology
Accra
The Bank Hospital
Cantonments
Komfo Anokye Teaching Hospital - Nephrology
Kumasi
Netherlands (1)
Amsterdam UMC - Amsterdam Public Health Research Institute
Amsterdam
COMPLETED
Nigeria (5)
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
Portugal (4)
Unidade Local de Saude Amadora/Sintra, E.P.E.
Amadora
COMPLETED
Hospital Curry Cabral - Serviço de Nefrologia
Lisbon
COMPLETED
Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology
Lisbon
COMPLETED
Unidade Local de Saúde de Loures-Odivelas, E.P.E.
Loures
COMPLETED
Puerto Rico (3)
FDI Clinical Research
Mayagüez
University of Puerto Rico
Rio Piedras
GCM Medical Group, PSC
San Juan
COMPLETED
Spain (5)
Hospital Clinic de Barcelona - Nephrology
Barcelona
COMPLETED
Hospital Universitari Vall d´Hebron - Servicio de Pediatria
Barcelona
COMPLETED
Reina Sofia University Hospital - Nephrology
Córdoba
COMPLETED
Hospital Universitario 12 de Octubre - Nephrology
Madrid
COMPLETED
Hospital Universitario Virgen Macarena
Seville
COMPLETED
United Kingdom (18)
Mid and South Essex Hospitals NHS Trust
Basildon
Synexus Clinical Research - Glasgow (DRS)
Bellshill
FutureMeds Birmingham
Birmingham
COMPLETED
Queen Elizabeth Hospital Birmingham
Birmingham
Synexus Clinical Research - Midlands (DRS)
Birmingham
Epsom and St Helier University Hospitals NHS Trust
Carshalton
COMPLETED
Leicester General Hospital
Leicester
Great Ormond Street Hospital for Children
London
COMPLETED
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
United States (227)
American Clinical Trials LLC - Acworth
Acworth , Georgia
Alabama Kidney Research
Alabaster , Alabama
New Mexico VA Healthcare System
Albuquerque , New Mexico
COMPLETED
Renal Medicine Associates
Albuquerque , New Mexico
COMPLETED
A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
Ann Arbor , Michigan
Javara Inc./Privia Medical Group - Annapolis, MD
Annapolis , Maryland
Dallas Renal Group - Mansfield
Arlington , Texas
COMPLETED
Arlington Nephrology
Arlington , Texas
COMPLETED
Kaiser Permanente Georgia
Atlanta , Georgia
Emory School of Medicine - Renal Division
Atlanta , Georgia
Advanced Clinical Research of Atlanta
Atlanta , Georgia
COMPLETED
Morehouse School of Medicine, Grady Memorial Hospital
Atlanta , Georgia
Emory Childrens Center - Nephrology
Atlanta , Georgia
Synexus Clinical Research - Atlanta (DRS)
Atlanta , Georgia
Fides Clinical Research
Atlanta , Georgia
Augusta University Medical College of Georgia - Adult Sickle Cell Clinic
Augusta , Georgia
University of Maryland Medical Center - General Clinical Research Center
Baltimore , Maryland
COMPLETED
The Johns Hopkins University - Johns Hopkins Hospital - Nephrology
Baltimore , Maryland
Renal Associates of Baton Rouge
Baton Rouge , Louisiana
Bay Pines Foundation
Bay Pines , Florida
EmVenio Research - Mobile Unit - Birmingham
Birmingham , Alabama
Cardiology, P.C.
Birmingham , Alabama
COMPLETED
Children's Hospital of Alabama
Birmingham , Alabama
The Kirklin Clinic - Nephrology
Birmingham , Alabama
Greater Hartford Nephrology
Bloomfield , Connecticut
Tufts Medical Center
Boston , Massachusetts
Boston Medical Center
Boston , Massachusetts
Beth Israel Deaconess Medical Center - Nephrology
Boston , Massachusetts
Nova Clinical Research, LLC - Bradenton - 59th St
Bradenton , Florida
Clinical Research of Brandon, LLC
Brandon , Florida
Kings County Hospital
Brooklyn , New York
SUNY Downstate Health Sciences University
Brooklyn , New York
Clindove Research LLC
Brooklyn , New York
COMPLETED
Coastal Medical Research
Brunswick , Georgia
COMPLETED
CUH - Sheridan Pavilion - Three Cooper Plaza
Camden , New Jersey
North Carolina Nephrology P.A. - Cary
Cary , North Carolina
UNC Clinical and Translational Research Center
Chapel Hill , North Carolina
Pharmacorp Clinical Trials, Inc
Charleston , South Carolina
Medical University of South Carolina - Pulmonology
Charleston , South Carolina
Metrolina Nephrology Associates - Freedom Dr
Charlotte , North Carolina
UVA Health - Nephrology Clinical Research Center
Charlottesville , Virginia
Southeast Renal Research Institute
Chattanooga , Tennessee
Synexus Clinical Research - Chicago (DRS)
Chicago , Illinois
EmVenio Research - Chicago
Chicago , Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology
Chicago , Illinois
Northwestern Medical Group
Chicago , Illinois
UChicago Medicine - Comer Children's Hospital
Chicago , Illinois
UC - DCI McMillan Research Unit
Cincinnati , Ohio
Cincinnati VA Medical Center
Cincinnati , Ohio
COMPLETED
Louis Stokes Cleveland VA medical Center
Cleveland , Ohio
UH Cleveland Medical Center - Nephrology
Cleveland , Ohio
Cleveland Clinic - Main Campus
Cleveland , Ohio
Randomize Now - College Park
College Park , Georgia
Columbia Nephrology Associates, PA
Columbia , South Carolina
Clincept - Veterans Pkwy.
Columbus , Georgia
Renal Associates
Columbus , Georgia
Nephrology Associates, P.C. - Columbus
Columbus , Mississippi
Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit
Columbus , Ohio
AMR-Miami
Coral Gables , Florida
COMPLETED
Horizon Research Group - Coral Gables
Coral Gables , Florida
COMPLETED
South Florida Nephrology Research
Coral Springs , Florida
Baylor Scott and White Research Institute - Nephrology
Dallas , Texas
Dallas Renal Group- Dallas
Dallas , Texas
Zenos Clinical Research
Dallas , Texas
Nephrotex Research Group
Dallas , Texas
COMPLETED
Dallas Renal Group - Liberty Dallas Dialysis Center
Dallas , Texas
Dallas Nephrology Associates - Dallas Landry Office
Dallas , Texas
Southwest Family Medicine Associates (SFMA) - Dallas
Dallas , Texas
UTSW Medical Center - Nephrology
Dallas , Texas
Georgia Nephrology - Decatur
Decatur , Georgia
Atlanta VA Healthcare System
Decatur , Georgia
COMPLETED
Delray Physician Care Center
Delray Beach , Florida
Henry Ford Health System - Nephrology
Detroit , Michigan
American Clinical Trials LLC - Douglasville
Douglasville , Georgia
Duke University Hospital - Children's Health Center
Durham , North Carolina
Southeast Kidney Associates
East Point , Georgia
Lifespan Clinical Research Center
East Providence , Rhode Island
InterMed Consultants - Edina Clinic
Edina , Minnesota
COMPLETED
Davita Clinical Research - El Paso
El Paso , Texas
NANI Research LLC - Evergreen Park IL
Evergreen Park , Illinois
Nephrology Associates
Fairhope , Alabama
Quest Research Institute
Farmington Hills , Michigan
COMPLETED
Prime Health and Wellness
Fayette , Mississippi
Javara Inc./Privia Medical Group - Fayetteville, GA
Fayetteville , Georgia
AA Medical Research Center
Flint , Michigan
New York Presbyterian Queens
Flushing , New York
NANI Research LLC - Fort Wayne IN
Fort Wayne , Indiana
Cook Children's Medical Center
Fort Worth , Texas
The Medical Research Group - Saint Agnes Medical Center
Fresno , California
North Florida/South Georgia Veterans Health System
Gainesville , Florida
Shands Hospital - Nephrology
Gainesville , Florida
Mid-Atlantic Permanente Research Institute
Gaithersburg , Maryland
Amicis Research Center - Balboa
Granada Hills , California
Kidney Care Center of North Valley
Granada Hills , California
Zucker School of Medicine
Great Neck , New York
Eastern Nephrology Associates - Greenville Office
Greenville , North Carolina
UMMC Grenada Hospital
Grenada , Mississippi
COMPLETED
Hackensack University Medical Center
Hackensack , New Jersey
Velocity Clinical Research - Hallandale Beach
Hallandale , Florida
COMPLETED
Bioluminux Clinical Research New Jersey
Hamilton , New Jersey
Qway Research
Hialeah , Florida
COMPLETED
Edward Hines Jr VA Hospital
Hines , Illinois
Elixia Pines
Hollywood , Florida
COMPLETED
Prolato Clinical Research Center - Kirby Dr
Houston , Texas
Ronald Ralph MD PA
Houston , Texas
Houston Medical Research Institute, LLC
Houston , Texas
COMPLETED
Clinical Research Strategies - Romano North Main Office
Houston , Texas
COMPLETED
Frenova-Southwest Houston
Houston , Texas
COMPLETED
Heart Center Research LLC
Huntsville , Alabama
Nephrology Consultants, LLC
Huntsville , Alabama
IU School of Medicine - Nephrology
Indianapolis , Indiana
University of Iowa Health Care Medical Center- Nephrology
Iowa City , Iowa
G.V. (Sonny) Montgomery VAMC
Jackson , Mississippi
COMPLETED
UF Health Cardiovascular Center - Jacksonville
Jacksonville , Florida
Eastern Nephrology Associates - Jacksonville Office
Jacksonville , North Carolina
Clinical & Translational Science Unit (CTSU) - Nephrology
Kansas City , Kansas
COMPLETED
Eastern Nephrology Associates - Kinston Office
Kinston , North Carolina
Sparrow Clinical Research Institute
Lansing , Michigan
Nevada Kidney Disease and Hypertension Centers
Las Vegas , Nevada
WITHDRAWN
DaVita Kidney Care - Las Vegas
Las Vegas , Nevada
South Florida Research Institute
Lauderdale Lakes , Florida
Scott Research, Inc.
Laurelton , New York
Georgia Nephrology - Lawrenceville - Billing Office
Lawrenceville , Georgia
NTKDA Lewisville
Lewisville , Texas
COMPLETED
Prime Clinical Research Inc - Lewisville
Lewisville , Texas
CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock
Little Rock , Arkansas
COMPLETED
UAMS Medical Center - Pulmonology
Little Rock , Arkansas
COMPLETED
Eastside Clinical Research Associates
Los Angeles , California
Kaiser Permanente Los Angeles Medical Center
Los Angeles , California
Cedars-Sinai Medical Center
Los Angeles , California
UCLA Division of Nephrology
Los Angeles , California
COMPLETED
Texas Tech University Health Sciences Center
Lubbock , Texas
Patient First Clinical Trials
Lutherville , Maryland
Prime Clinical Research - Mansfield - Regency Parkway
Mansfield , Texas
Le Bonheur Children's Hospital - Outpatient Clinic
Memphis , Tennessee
CNS Healthcare - Memphis
Memphis , Tennessee
Arizona Kidney Disease and Hypertension Center - Banner Desert Office
Mesa , Arizona
WITHDRAWN
LCMC Health
Metairie , Louisiana
Total Research Group, LLC
Miami , Florida
MedBio Trials
Miami , Florida
WITHDRAWN
Cordova Research Institute
Miami , Florida
South Florida Research
Miami Springs , Florida
Nephrology & Hypertension Associates, PC
Middlebury , Connecticut
Medical College of Wisconsin - Pulmonology
Milwaukee , Wisconsin
Minneapolis VA Healthcare System
Minneapolis , Minnesota
COMPLETED
Nephrology Physicians, LLC
Mishawaka , Indiana
COMPLETED
Renal Associates of Alabama, LLC
Montgomery , Alabama
Nashville General Hospital - Meharry Medical College - Nephrology
Nashville , Tennessee
Nashville VA Medical Center
Nashville , Tennessee
Nephrology Clinical Trials Center
Nashville , Tennessee
Barnum Medical Research - Bienville St
Natchitoches , Louisiana
COMPLETED
Jersey Shore University Medical Center
Neptune City , New Jersey
Eastern Nephrology Associates - New Bern Office
New Bern , North Carolina
Yale University - Yale Nephrology Clinical Research Clinic
New Haven , Connecticut
Louisiana Clinical and Translational Science (LA CaTS) Center
New Orleans , Louisiana
COMPLETED
University Medical Center - New Orleans - Nephrology
New Orleans , Louisiana
Ochsner Medical Center - New Orleans
New Orleans , Louisiana
VA New York Harbor Healthcare System
New York , New York
COMPLETED
Grossman School of Medicine
New York , New York
Synexus Clinical Research - New York (DRS)
New York , New York
COMPLETED
The Rogosin Kidney Center
New York , New York
Icahn School of Medicine at Mount Sinai - Nephrology
New York , New York
General Nephrology Clinic - New York City
New York , New York
NYC Health + Hospital/Harlem
New York , New York
Rutgers Doctors Office Center
Newark , New Jersey
Tidewater Kidney Specialists - Church St.
Norfolk , Virginia
York Clinical Research, LLC
Norfolk , Virginia
COMPLETED
Olive Branch Family Medical Center
Olive Branch , Mississippi
UCI Center for Clinical Research
Orange , California
CTR Oakwater, LLC
Orlando , Florida
ACTIVE_NOT_RECRUITING
Synexus Clinical Research - Orlando
Orlando , Florida
COMPLETED
Omega Research Orlando, LLC - Mercy Dr
Orlando , Florida
Premier Clinical Research
Overland Park , Kansas
COMPLETED
MD Medical Research
Oxon Hill , Maryland
Essential Concepts Research Solutions
Palos Hills , Illinois
COMPLETED
Lewis Katz School of Medicine at Temple University - Section of Nephrology
Philadelphia , Pennsylvania
Jefferson Einstein Philadelphia Hospital - Nephrology
Philadelphia , Pennsylvania
Jefferson Health - 33 South 9th Street
Philadelphia , Pennsylvania
COMPLETED
Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix , Arizona
Phoenix Children's Hospital, Inc. - Nephrology
Phoenix , Arizona
Children's Hospital of Pittsburgh - Nephrology
Pittsburgh , Pennsylvania
ACTIVE_NOT_RECRUITING
McGuire Research Institute, Inc. (151)
Richmond , Virginia
Virginia Commonwealth University - Division of Nephrology
Richmond , Virginia
SKY Integrative Medical Center
Ridgeland , Mississippi
St. Clair Nephrology Research
Roseville , Michigan
COMPLETED
Whittier Street Health Center
Roxbury , Massachusetts
Kaiser Permanente Sacramento Medical Center
Sacramento , California
Center for Advanced Kidney Research
Saint Clair Shores , Michigan
San Antonio Kidney Disease Center Physicians Group - Medical Center
San Antonio , Texas
WITHDRAWN
University of Texas Health Science Center - Nephrology
San Antonio , Texas
COMPLETED
San Antonio Kidney Disease Center Physicians Group - Westover Hills
San Antonio , Texas
COMPLETED
Helen Diller Medical Center at Parnassus Heights
San Francisco , California
Infigo Clinical Research
Sanford , Florida
Javara Inc./Privia Medical Group - Savannah, GA
Savannah , Georgia
UW Medical Center - Montlake - Nephrology
Seattle , Washington
Kidney Specialists of N Houston, PLLC
Shenandoah , Texas
Northwest Louisiana Nephrology, LLC
Shreveport , Louisiana
Louisiana State University Health Shreveport
Shreveport , Louisiana
Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike
Silver Spring , Maryland
Carolina Nephrology, PA
Spartanburg , South Carolina
Renal and Transplant Associates of New England, PC
Springfield , Massachusetts
COMPLETED
Center for Specialized Medicine - Nephrology
St Louis , Missouri
COMPLETED
Barnes-Jewish Center for Outpatient Health
St Louis , Missouri
St. Louis Children's Hospital - Nephrology
St Louis , Missouri
St. Louis Heart and Vascular, P.C.
St Louis , Missouri
Genesis Clinical Research
Tampa , Florida
COMPLETED
Elixia Tampa
Tampa , Florida
COMPLETED
Kidney Medical Associates, PLLC
The Bronx , New York
COMPLETED
Montefiore Einstein - Albert Einstein College of Medicine
The Bronx , New York
Montefiore Einstein Hospital - Moses Campus
The Bronx , New York
James J. Peters VA Medical Center
The Bronx , New York
Renal Research of Montgomery County, PLLC
The Woodlands , Texas
UCLA Lundquist Institute at Harbor-UCLA Medical Center
Torrance , California
Nephrology and Hypertension Associates - Tupelo
Tupelo , Mississippi
Inova Clinical Trials and Research Center
Tyrone , Georgia
Rophe Adult and Pediatric Medicine
Union City , Georgia
Kidney and Hypertension Center
Victorville , California
COMPLETED
Nephrology Associates of Tidewater, LTD
Virginia Beach , Virginia
COMPLETED
Children's National Hospital - Nephrology
Washington D.C. , District of Columbia
The George Washington University - GW Medical Faculty Associates
Washington D.C. , District of Columbia
Veterans Affairs Medical Center - Washington D.C
Washington D.C. , District of Columbia
Milwaukee Nephrologists - Wauwatosa
Wauwatosa , Wisconsin
Tranquil Clinical Research
Webster , Texas
Monroe Research, LLC
West Monroe , Louisiana
Kidney Care and Transplant Services of New England - West Springfield
West Springfield , Massachusetts
Eastern Nephrology Associates - Wilmington Office
Wilmington , North Carolina
Brookview Hills Research Associates
Winston-Salem , North Carolina
COMPLETED
Technical details
Status
Recruiting
Phase
Phase 2/3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
10 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
30.03.2022
Completion date
07.05.2030
Registry ID
NCT05312879
Source
clinicaltrials.gov
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