Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease
AMPLITUDE
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
2 other identifiers
interventional
466
13 countries
318
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2022
Longer than P75 for phase_2
318 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2022
CompletedStudy Start
First participant enrolled
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 7, 2030
April 17, 2026
April 1, 2026
6.2 years
March 28, 2022
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Part A: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)
From Baseline to Week 48
Part A: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at Interim Analysis
From Baseline Through >= Week 48
Part A: eGFR Slope Assessed at 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)
Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)
Secondary Outcomes (7)
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
Part A: Maximum Plasma Concentration (Cmax) of VX-147
Day 1 and Week 40
Part A: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147
Day 1 and Week 40
Part A: Observed Pre-dose Plasma Concentration (Ctrough) of VX-147
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
Day 1 and Week 48
- +2 more secondary outcomes
Study Arms (3)
Part A (Phase 2/3): VX-147
EXPERIMENTALParticipants will be randomized to receive different doses of VX-147. Participants will receive the selected dose of VX-147 for atleast 96 weeks.
Part A (Phase 2/3): Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to VX-147.
Part B (Phase 3): VX-147
EXPERIMENTALParticipants who complete Part A will receive VX-147 for an additional 96 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (318)
Alabama Kidney Research
Alabaster, Alabama, 35007, United States
EmVenio Research - Mobile Unit - Birmingham
Birmingham, Alabama, 35210, United States
Cardiology, P.C.
Birmingham, Alabama, 35211, United States
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
The Kirklin Clinic - Nephrology
Birmingham, Alabama, 35294, United States
Nephrology Associates
Fairhope, Alabama, 36532, United States
Heart Center Research LLC
Huntsville, Alabama, 35801, United States
Nephrology Consultants, LLC
Huntsville, Alabama, 35805, United States
Renal Associates of Alabama, LLC
Montgomery, Alabama, 36117, United States
Arizona Kidney Disease and Hypertension Center - Banner Desert Office
Mesa, Arizona, 85202, United States
Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix, Arizona, 85016, United States
Phoenix Children's Hospital, Inc. - Nephrology
Phoenix, Arizona, 85016, United States
CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock
Little Rock, Arkansas, 72204, United States
UAMS Medical Center - Pulmonology
Little Rock, Arkansas, 72205, United States
The Medical Research Group - Saint Agnes Medical Center
Fresno, California, 93720, United States
Amicis Research Center - Balboa
Granada Hills, California, 91344, United States
Kidney Care Center of North Valley
Granada Hills, California, 91344, United States
Eastside Clinical Research Associates
Los Angeles, California, 90022, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA Division of Nephrology
Los Angeles, California, 90095, United States
UCI Center for Clinical Research
Orange, California, 92868, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825, United States
Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143, United States
UCLA Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Kidney and Hypertension Center
Victorville, California, 92395, United States
Greater Hartford Nephrology
Bloomfield, Connecticut, 06002, United States
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut, 06762, United States
Yale University - Yale Nephrology Clinical Research Clinic
New Haven, Connecticut, 06510, United States
Children's National Hospital - Nephrology
Washington D.C., District of Columbia, 20010, United States
The George Washington University - GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Veterans Affairs Medical Center - Washington D.C
Washington D.C., District of Columbia, 20422, United States
Bay Pines Foundation
Bay Pines, Florida, 33744, United States
Nova Clinical Research, LLC - Bradenton - 59th St
Bradenton, Florida, 34209, United States
Clinical Research of Brandon, LLC
Brandon, Florida, 33511, United States
AMR-Miami
Coral Gables, Florida, 33134, United States
Horizon Research Group - Coral Gables
Coral Gables, Florida, 33134, United States
South Florida Nephrology Research
Coral Springs, Florida, 33071, United States
Delray Physician Care Center
Delray Beach, Florida, 33445, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
Shands Hospital - Nephrology
Gainesville, Florida, 32610, United States
Velocity Clinical Research - Hallandale Beach
Hallandale, Florida, 33009, United States
Qway Research
Hialeah, Florida, 33010, United States
Elixia Pines
Hollywood, Florida, 33024, United States
UF Health Cardiovascular Center - Jacksonville
Jacksonville, Florida, 32209, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313, United States
Total Research Group, LLC
Miami, Florida, 33126, United States
MedBio Trials
Miami, Florida, 33180, United States
Cordova Research Institute
Miami, Florida, 33182, United States
South Florida Research
Miami Springs, Florida, 33166, United States
CTR Oakwater, LLC
Orlando, Florida, 32806, United States
Synexus Clinical Research - Orlando
Orlando, Florida, 32806, United States
Omega Research Orlando, LLC - Mercy Dr
Orlando, Florida, 32808, United States
Infigo Clinical Research
Sanford, Florida, 32771, United States
Genesis Clinical Research
Tampa, Florida, 33603, United States
Elixia Tampa
Tampa, Florida, 33618, United States
American Clinical Trials LLC - Acworth
Acworth, Georgia, 30101, United States
Kaiser Permanente Georgia
Atlanta, Georgia, 30305, United States
Emory School of Medicine - Renal Division
Atlanta, Georgia, 30308, United States
Advanced Clinical Research of Atlanta
Atlanta, Georgia, 30309, United States
Morehouse School of Medicine, Grady Memorial Hospital
Atlanta, Georgia, 30310, United States
Emory Childrens Center - Nephrology
Atlanta, Georgia, 30322, United States
Synexus Clinical Research - Atlanta (DRS)
Atlanta, Georgia, 30328, United States
Fides Clinical Research
Atlanta, Georgia, 30342, United States
Augusta University Medical College of Georgia - Adult Sickle Cell Clinic
Augusta, Georgia, 30912, United States
Coastal Medical Research
Brunswick, Georgia, 31520, United States
Randomize Now - College Park
College Park, Georgia, 30337, United States
Clincept - Veterans Pkwy.
Columbus, Georgia, 31904, United States
Renal Associates
Columbus, Georgia, 31904, United States
Georgia Nephrology - Decatur
Decatur, Georgia, 30030, United States
Atlanta VA Healthcare System
Decatur, Georgia, 30033, United States
American Clinical Trials LLC - Douglasville
Douglasville, Georgia, 30134, United States
Southeast Kidney Associates
East Point, Georgia, 30344, United States
Javara Inc./Privia Medical Group - Fayetteville, GA
Fayetteville, Georgia, 30214, United States
Georgia Nephrology - Lawrenceville - Billing Office
Lawrenceville, Georgia, 30046, United States
Javara Inc./Privia Medical Group - Savannah, GA
Savannah, Georgia, 31406, United States
Inova Clinical Trials and Research Center
Tyrone, Georgia, 30290, United States
Rophe Adult and Pediatric Medicine
Union City, Georgia, 30291, United States
Synexus Clinical Research - Chicago (DRS)
Chicago, Illinois, 60602, United States
EmVenio Research - Chicago
Chicago, Illinois, 60608, United States
Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology
Chicago, Illinois, 60611-2605, United States
Northwestern Medical Group
Chicago, Illinois, 60611, United States
UChicago Medicine - Comer Children's Hospital
Chicago, Illinois, 60637, United States
NANI Research LLC - Evergreen Park IL
Evergreen Park, Illinois, 60805, United States
Edward Hines Jr VA Hospital
Hines, Illinois, 60141, United States
Essential Concepts Research Solutions
Palos Hills, Illinois, 60465, United States
NANI Research LLC - Fort Wayne IN
Fort Wayne, Indiana, 46804, United States
IU School of Medicine - Nephrology
Indianapolis, Indiana, 46202, United States
Nephrology Physicians, LLC
Mishawaka, Indiana, 46545, United States
University of Iowa Health Care Medical Center- Nephrology
Iowa City, Iowa, 52242, United States
Clinical & Translational Science Unit (CTSU) - Nephrology
Kansas City, Kansas, 66160, United States
Premier Clinical Research
Overland Park, Kansas, 66210, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
LCMC Health
Metairie, Louisiana, 70006, United States
Barnum Medical Research - Bienville St
Natchitoches, Louisiana, 71457, United States
Louisiana Clinical and Translational Science (LA CaTS) Center
New Orleans, Louisiana, 70112, United States
University Medical Center - New Orleans - Nephrology
New Orleans, Louisiana, 70112, United States
Ochsner Medical Center - New Orleans
New Orleans, Louisiana, 70121, United States
Northwest Louisiana Nephrology, LLC
Shreveport, Louisiana, 71101, United States
Louisiana State University Health Shreveport
Shreveport, Louisiana, 71103, United States
Monroe Research, LLC
West Monroe, Louisiana, 71291, United States
Javara Inc./Privia Medical Group - Annapolis, MD
Annapolis, Maryland, 21401, United States
University of Maryland Medical Center - General Clinical Research Center
Baltimore, Maryland, 21201, United States
The Johns Hopkins University - Johns Hopkins Hospital - Nephrology
Baltimore, Maryland, 21287, United States
Mid-Atlantic Permanente Research Institute
Gaithersburg, Maryland, 20879, United States
Patient First Clinical Trials
Lutherville, Maryland, 21093, United States
MD Medical Research
Oxon Hill, Maryland, 20745, United States
Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike
Silver Spring, Maryland, 20901, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center - Nephrology
Boston, Massachusetts, 02215, United States
Whittier Street Health Center
Roxbury, Massachusetts, 02120, United States
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, 01107, United States
Kidney Care and Transplant Services of New England - West Springfield
West Springfield, Massachusetts, 01089, United States
A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System - Nephrology
Detroit, Michigan, 48202, United States
Quest Research Institute
Farmington Hills, Michigan, 48334, United States
AA Medical Research Center
Flint, Michigan, 48504, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
St. Clair Nephrology Research
Roseville, Michigan, 48066, United States
Center for Advanced Kidney Research
Saint Clair Shores, Michigan, 48081, United States
InterMed Consultants - Edina Clinic
Edina, Minnesota, 55435, United States
Minneapolis VA Healthcare System
Minneapolis, Minnesota, 55417, United States
Nephrology Associates, P.C. - Columbus
Columbus, Mississippi, 39705, United States
Prime Health and Wellness
Fayette, Mississippi, 39069, United States
UMMC Grenada Hospital
Grenada, Mississippi, 38901, United States
G.V. (Sonny) Montgomery VAMC
Jackson, Mississippi, 39216, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
SKY Integrative Medical Center
Ridgeland, Mississippi, 39157, United States
Nephrology and Hypertension Associates - Tupelo
Tupelo, Mississippi, 38801, United States
Center for Specialized Medicine - Nephrology
St Louis, Missouri, 63104, United States
Barnes-Jewish Center for Outpatient Health
St Louis, Missouri, 63108, United States
St. Louis Children's Hospital - Nephrology
St Louis, Missouri, 63110, United States
St. Louis Heart and Vascular, P.C.
St Louis, Missouri, 63136, United States
Nevada Kidney Disease and Hypertension Centers
Las Vegas, Nevada, 89106, United States
DaVita Kidney Care - Las Vegas
Las Vegas, Nevada, 89107, United States
CUH - Sheridan Pavilion - Three Cooper Plaza
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Bioluminux Clinical Research New Jersey
Hamilton, New Jersey, 08690, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Rutgers Doctors Office Center
Newark, New Jersey, 07103, United States
New Mexico VA Healthcare System
Albuquerque, New Mexico, 87108, United States
Renal Medicine Associates
Albuquerque, New Mexico, 87109, United States
Kings County Hospital
Brooklyn, New York, 11203, United States
SUNY Downstate Health Sciences University
Brooklyn, New York, 11203, United States
Clindove Research LLC
Brooklyn, New York, 11221, United States
New York Presbyterian Queens
Flushing, New York, 11365, United States
Zucker School of Medicine
Great Neck, New York, 11021, United States
Scott Research, Inc.
Laurelton, New York, 11413, United States
VA New York Harbor Healthcare System
New York, New York, 10010, United States
Grossman School of Medicine
New York, New York, 10016, United States
Synexus Clinical Research - New York (DRS)
New York, New York, 10017, United States
The Rogosin Kidney Center
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai - Nephrology
New York, New York, 10029, United States
General Nephrology Clinic - New York City
New York, New York, 10032, United States
NYC Health + Hospital/Harlem
New York, New York, 10037, United States
Kidney Medical Associates, PLLC
The Bronx, New York, 10461, United States
Montefiore Einstein - Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Montefiore Einstein Hospital - Moses Campus
The Bronx, New York, 10467, United States
James J. Peters VA Medical Center
The Bronx, New York, 10468, United States
North Carolina Nephrology P.A. - Cary
Cary, North Carolina, 27511, United States
UNC Clinical and Translational Research Center
Chapel Hill, North Carolina, 27599-7155, United States
Metrolina Nephrology Associates - Freedom Dr
Charlotte, North Carolina, 28208, United States
Duke University Hospital - Children's Health Center
Durham, North Carolina, 27710, United States
Eastern Nephrology Associates - Greenville Office
Greenville, North Carolina, 27834, United States
Eastern Nephrology Associates - Jacksonville Office
Jacksonville, North Carolina, 28546, United States
Eastern Nephrology Associates - Kinston Office
Kinston, North Carolina, 28504, United States
Eastern Nephrology Associates - New Bern Office
New Bern, North Carolina, 28562, United States
Eastern Nephrology Associates - Wilmington Office
Wilmington, North Carolina, 28401, United States
Brookview Hills Research Associates
Winston-Salem, North Carolina, 27103, United States
UC - DCI McMillan Research Unit
Cincinnati, Ohio, 45206, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
Louis Stokes Cleveland VA medical Center
Cleveland, Ohio, 44106, United States
UH Cleveland Medical Center - Nephrology
Cleveland, Ohio, 44106, United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195, United States
Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit
Columbus, Ohio, 43201, United States
Jefferson Health - 33 South 9th Street
Philadelphia, Pennsylvania, 19107, United States
Lewis Katz School of Medicine at Temple University - Section of Nephrology
Philadelphia, Pennsylvania, 19140, United States
Jefferson Einstein Philadelphia Hospital - Nephrology
Philadelphia, Pennsylvania, 19141, United States
Children's Hospital of Pittsburgh - Nephrology
Pittsburgh, Pennsylvania, 15224, United States
Lifespan Clinical Research Center
East Providence, Rhode Island, 02915, United States
Pharmacorp Clinical Trials, Inc
Charleston, South Carolina, 29412, United States
Medical University of South Carolina - Pulmonology
Charleston, South Carolina, 29425, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203, United States
Carolina Nephrology, PA
Spartanburg, South Carolina, 29306, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404, United States
Le Bonheur Children's Hospital - Outpatient Clinic
Memphis, Tennessee, 38105, United States
CNS Healthcare - Memphis
Memphis, Tennessee, 38119, United States
Nashville General Hospital - Meharry Medical College - Nephrology
Nashville, Tennessee, 37208, United States
Nashville VA Medical Center
Nashville, Tennessee, 37212, United States
Nephrology Clinical Trials Center
Nashville, Tennessee, 37232, United States
Dallas Renal Group - Mansfield
Arlington, Texas, 76002, United States
Arlington Nephrology
Arlington, Texas, 76015, United States
Baylor Scott and White Research Institute - Nephrology
Dallas, Texas, 75204, United States
Dallas Renal Group- Dallas
Dallas, Texas, 75230, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
Nephrotex Research Group
Dallas, Texas, 75231, United States
Dallas Renal Group - Liberty Dallas Dialysis Center
Dallas, Texas, 75237, United States
Dallas Nephrology Associates - Dallas Landry Office
Dallas, Texas, 75246, United States
Southwest Family Medicine Associates (SFMA) - Dallas
Dallas, Texas, 75325, United States
UTSW Medical Center - Nephrology
Dallas, Texas, 75390, United States
Davita Clinical Research - El Paso
El Paso, Texas, 79925, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Prolato Clinical Research Center - Kirby Dr
Houston, Texas, 77054, United States
Ronald Ralph MD PA
Houston, Texas, 77054, United States
Houston Medical Research Institute, LLC
Houston, Texas, 77074, United States
Clinical Research Strategies - Romano North Main Office
Houston, Texas, 77090, United States
Frenova-Southwest Houston
Houston, Texas, 77099, United States
NTKDA Lewisville
Lewisville, Texas, 75057, United States
Prime Clinical Research Inc - Lewisville
Lewisville, Texas, 75067, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Prime Clinical Research - Mansfield - Regency Parkway
Mansfield, Texas, 76063, United States
San Antonio Kidney Disease Center Physicians Group - Medical Center
San Antonio, Texas, 78229, United States
University of Texas Health Science Center - Nephrology
San Antonio, Texas, 78229, United States
San Antonio Kidney Disease Center Physicians Group - Westover Hills
San Antonio, Texas, 78251, United States
Kidney Specialists of N Houston, PLLC
Shenandoah, Texas, 77384, United States
Renal Research of Montgomery County, PLLC
The Woodlands, Texas, 77384, United States
Tranquil Clinical Research
Webster, Texas, 77598, United States
UVA Health - Nephrology Clinical Research Center
Charlottesville, Virginia, 22908, United States
Tidewater Kidney Specialists - Church St.
Norfolk, Virginia, 23504, United States
York Clinical Research, LLC
Norfolk, Virginia, 23504, United States
McGuire Research Institute, Inc. (151)
Richmond, Virginia, 23249, United States
Virginia Commonwealth University - Division of Nephrology
Richmond, Virginia, 23298, United States
Nephrology Associates of Tidewater, LTD
Virginia Beach, Virginia, 23454, United States
UW Medical Center - Montlake - Nephrology
Seattle, Washington, 98195, United States
Medical College of Wisconsin - Pulmonology
Milwaukee, Wisconsin, 53226, United States
Milwaukee Nephrologists - Wauwatosa
Wauwatosa, Wisconsin, 53226, United States
Universite Catholique de Louvain - Pulmonology
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology
Leuven, Belgium
Centro de Pesquisa Clinica do Coracao
Aracaju, Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Brazil
Faculdade de Medicina de Botucatu - CKD and Hypertension Department
Botucatu, Brazil
Faculdade de Medicina de Botucatu - Kidney Transplantation Department
Botucatu, Brazil
IPECC - Instituto de Pesquisa Clinica de Campinas
Campinas, Brazil
Instituto Pro-Renal
Curitiba, Brazil
PUC Trials - Unidade Epicenter
Curitiba, Brazil
Instituto de Ensino e Pesquisa Clinica do Ceara
Fortaleza, Brazil
Walter Cantídio University Hospital
Fortaleza, Brazil
Federal University of Goiás (UFG)
Goiânia, Brazil
Cmip-Centro Mineiro de Pesquisa Ltda
Juiz de Fora, Brazil
Galileo Medical Research Ltda
Juiz de Fora, Brazil
ICM - Instituto do Coracao de Marilia
Marília, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Monte Alegre, Brazil
Dom Vicente Scherer Hospital
Porto Alegre, Brazil
Hospital de Clínicas de Porto Alegre - Nephrology
Porto Alegre, Brazil
Centro de Pesquisa Clinica Professor Salomao Kelner
Recife, Brazil
Hospital São Lucas
Rio de Janeiro, Brazil
Hospital Universitario Pedro Ernesto - Departamento de Nefrologia
Rio de Janeiro, Brazil
Hospital Universitario Pedro Ernesto - Departamento de Patologia
Rio de Janeiro, Brazil
Comlexo Hospitalar Universitário Professor Edgard Santos
Salvador, Brazil
CSB Group of Nephrology Brazil
Salvador, Brazil
Hospital Ana Nery/SESAB
Salvador, Brazil
Praxis Pesquisa Medica
Santo André, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, Brazil
Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular
São Paulo, Brazil
Hospital do Rim - Fundação Oswaldo Ramos
São Paulo, Brazil
Hospital Nove de Julho - Nephrology
São Paulo, Brazil
Irmandade Da Santa Casa De Misericordia De Sao Paulo
São Paulo, Brazil
Recherche GCP Research
Montreal, Canada
Women's College Hospital
Toronto, Canada
Clinica de La Costa S.A.S
Atlántico, Colombia
Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO
Bogotá, Colombia
Fundación Valle Del Lili
Cali, Colombia
Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS
Cartagena, Colombia
Mediservis del Tolima IPS S.A.S.
Ibague, Colombia
Fundación Hospitalaria San Vicente de Paul
Medellín, Colombia
Promotora Medica Las Americas S.A. - Clinica Las Americas
Medellín, Colombia
Hopital Henri Mondor - Nephrology
Créteil, France
Hospital Nord Michallon - Nephrology
Grenoble, France
Bicetre Hospital
Le Kremlin-Bicêtre, France
CHU Dupuytren 2 - Néphrologie, dialyse, transplantations
Limoges, France
Hôpital de la Conception
Marseille, France
Ambroise Paré Hospital
Paris, France
Hopital Necker Enfants Malades - Nephrology
Paris, France
Hopital Tenon
Paris, France
Université Paris-Descartes / Hôpital Européen Georges Pompidou
Paris, France
CHU de Guadeloupe
Pointe à Pitre, France
AURA Nord
Saint-Ouen, France
Hopital de Rangueil
Toulouse, France
University of Ghana Medical School - Nephrology
Accra, Ghana
The Bank Hospital
Cantonments, Ghana
Komfo Anokye Teaching Hospital - Nephrology
Kumasi, Ghana
Amsterdam UMC - Amsterdam Public Health Research Institute
Amsterdam, Netherlands
University of Nigeria Teaching Hospital
Enugu, Nigeria
University College Hospital
Ibadan, Nigeria
Lagos University Teaching Hospital
Idi Araba, Nigeria
Lagos State University Teaching Hospital
Ikeja, Nigeria
Nigerian Institute of Medical Research
Lagos, Nigeria
Unidade Local de Saude Amadora/Sintra, E.P.E.
Amadora, Portugal
Hospital Curry Cabral - Serviço de Nefrologia
Lisbon, Portugal
Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology
Lisbon, Portugal
Unidade Local de Saúde de Loures-Odivelas, E.P.E.
Loures, Portugal
FDI Clinical Research
Mayagüez, 06680, Puerto Rico
University of Puerto Rico
Rio Piedras, 00935, Puerto Rico
GCM Medical Group, PSC
San Juan, 00917, Puerto Rico
Hospital Clinic de Barcelona - Nephrology
Barcelona, Spain
Hospital Universitari Vall d´Hebron - Servicio de Pediatria
Barcelona, Spain
Reina Sofia University Hospital - Nephrology
Córdoba, Spain
Hospital Universitario 12 de Octubre - Nephrology
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Mid and South Essex Hospitals NHS Trust
Basildon, United Kingdom
Synexus Clinical Research - Glasgow (DRS)
Bellshill, United Kingdom
FutureMeds Birmingham
Birmingham, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Synexus Clinical Research - Midlands (DRS)
Birmingham, United Kingdom
Epsom and St Helier University Hospitals NHS Trust
Carshalton, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom
Guy's Hospital - Endocrinology
London, United Kingdom
King's College Hospital - Pulmonology
London, United Kingdom
Royal Free Hospital - Nephrology
London, United Kingdom
St George's Hospital London - Nephrology
London, United Kingdom
St Pancras Clinical Research
London, United Kingdom
The Royal London Hospital - Nephrology
London, United Kingdom
Manchester Royal Infirmary - Endocrinology
Manchester, United Kingdom
Synexus Clinical Research - NW Consortium Manchester (DRS)
Manchester, United Kingdom
Wythenshawe Hospital - Medicines Evaluation Unit
Manchester, United Kingdom
Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology
Nottingham, United Kingdom
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2022
First Posted
April 6, 2022
Study Start
March 30, 2022
Primary Completion (Estimated)
June 2, 2028
Study Completion (Estimated)
May 7, 2030
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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/