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

April 5, 2024 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
    - University Hospital Leuven
- Brussels
  - Woluwe-Saint-Lambert, Brussels, Belgium
    - Recruiting
    - Cliniques Universitaires Saint-Luc
Brazil
- - Belo Horizonte, Brazil
    - Recruiting
    - Santa Casa de Misericordia de Belo Horizonte
  - Curitiba, Brazil
    - Recruiting
    - Instituto Pro-Renal
  - Curitiba, Brazil
    - Recruiting
    - PUC Trials - Unidade Epicenter
  - Fortaleza, Brazil
    - Recruiting
    - Hospital Universitário Valter Cantídio
  - Goiania, Brazil
    - Recruiting
    - Federal University of Goiás (UFG)
  - Juiz De Fora, Brazil
    - Recruiting
    - Galileo Medical Research Ltda
  - Juiz de Fora, Brazil
    - Recruiting
    - Cmip-Centro Mineiro de Pesquisa Ltda
  - Porto Alegre, Brazil
    - Recruiting
    - Irmandade Da Santa Casa de Misericordia de Porto Alegre
  - Porto Alegre, Brazil
    - Recruiting
    - UFRS - Hospital de Clínicas
  - Ribeirao Preto, Brazil
    - Recruiting
    - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
  - Rio de Janeiro, Brazil
    - Recruiting
    - Hospital Universitário Pedro Ernesto
  - Rio de Janeiro, Brazil
    - Recruiting
    - Pedro Ernesto University Hospital
  - Rio de Janeiro, Brazil
    - Recruiting
    - Hospital São Lucas
  - Salvador, Brazil
    - Recruiting
    - CSB Group of Nephrology Brazil
  - Salvador, Brazil
    - Recruiting
    - Federal University of Bahia
  - São José do Rio Preto, Brazil
    - Recruiting
    - Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  - São Paulo, Brazil
    - Recruiting
    - University of Sao Paulo
  - São Paulo, Brazil
    - Recruiting
    - Hospital do Rim - Fundação Oswaldo Ramos - Ambulatorio NEFRITE
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
  - Bogota, Colombia
    - Recruiting
    - Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO
  - Cartagena, Colombia
    - Recruiting
    - Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS
  - Medellín, Colombia
    - Recruiting
    - Fundacion Hospitalaria San Vicente de Paul
France
- - Créteil, France
    - Recruiting
    - Hôpital Henri Mondor
  - Grenoble, France
    - Recruiting
    - CHU Grenoble Alpes - Hôpital Nord Michallon
  - Le Kremlin Bicêtre, France
    - Recruiting
    - Hôpital Bicêtre AP-HP
  - Limoges, France
    - Recruiting
    - CHU Dupuytren 2
  - Marseille, France, 13385
    - Recruiting
    - Hôpital de la Conception, Centre de néphrologie et transplantation rénale
  - Paris, France
    - Recruiting
    - Université Paris-Descartes / Hôpital Européen Georges Pompidou
  - Paris, France
    - Recruiting
    - Ambroise Paré Hospital
  - Paris, France
    - Recruiting
    - Service de Nephrologie - Hopital Universitaire Necker
  - Paris, France
    - Recruiting
    - Hopitaux Universitaires Est Parisien - Hopital Tenon
  - Saint-Ouen, France
    - Recruiting
    - AURA Nord Saint Ouen
  - Toulouse, France
    - Recruiting
    - Centre Hospitalier Universitaire CHU de Toulouse Hopital de Rangueil
Ghana
- - Accra, Ghana
    - Recruiting
    - University of Ghana Medical School
  - Kumasi, Ghana
    - Recruiting
    - Komfo Anokye Teaching Hospital
Netherlands
- - Amsterdam, Netherlands
    - Completed
    - University of Amsterdam
Portugal
- - Amadora, Portugal
    - Recruiting
    - Unidade Autónoma de Nefrologia
  - Lisboa, Portugal
    - Recruiting
    - Hospital Curry Cabral
  - Lisboa, Portugal
    - Recruiting
    - Department of Nephrology and Renal Transplant
  - Loures, Portugal
    - Recruiting
    - Hospital Beatriz Ângelo
Puerto Rico
- - Rio Piedras, Puerto Rico, 00935
    - Recruiting
    - Alliance, School of Medicine
  - San Juan, Puerto Rico, 00917
    - Completed
    - gcm Medical Group, Psc
Spain
- - Barcelona, Spain
    - Recruiting
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain
    - Recruiting
    - Hospital Clinic de Barcelona
  - Córdoba, Spain
    - Recruiting
    - Reina Sofia University Hospital
  - Madrid, Spain
    - Recruiting
    - Hospital Universitario 12 de Octubre
  - Seville, Spain
    - Recruiting
    - Hospital Universitario Virgen Macarena
United Kingdom
- - Birmingham, United Kingdom
    - Recruiting
    - University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
  - Birmingham, United Kingdom
    - Recruiting
    - FutureMeds Birmingham
  - Carshalton, United Kingdom
    - Recruiting
    - Epsom and St Helier University Hospitals NHS Trust - St Helier Hospital - South West SW Thames Institute for Renal Research
  - Leicester, United Kingdom
    - Recruiting
    - University Hospitals of Leicester NHS Trust - Leicester General Hospital
  - London, United Kingdom
    - Recruiting
    - Barts Health NHS Trust, The Royal London Hospital
  - London, United Kingdom
    - Recruiting
    - St George's University Hospitals NHS Foundation Trust
  - London, United Kingdom
    - Recruiting
    - Guy's & St Thomas NHS Foundation Trust, Guy's Hospital
  - London, United Kingdom
    - Recruiting
    - Royal Free NHS Trust
  - Manchester, United Kingdom
    - Recruiting
    - The Medicines Evaluation Unit
  - Manchester, United Kingdom
    - Recruiting
    - Manchester Royal Infirmary
  - Nottingham, United Kingdom
    - Recruiting
    - Nottingham University Hospital
  - Southwark, United Kingdom
    - Recruiting
    - King's College Hospital NHS Foundation Trust - Guthrie Clinic
United States
- Alabama
  - Huntsville, Alabama, United States, 35805
    - Recruiting
    - Nephrology Consultants, LLC
- Arizona
  - Mesa, Arizona, United States, 85202
    - Recruiting
    - AKDHC Medical Research Service LLC - Banner Desert Office
  - Phoenix, Arizona, United States, 85016
    - Withdrawn
    - AKDHC Medical Research Service LLC
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, United States, 72204
    - Recruiting
    - Cardiology and Medicine Clinic, P.A.
- California
  - Fresno, California, United States, 93720
    - Recruiting
    - The Medical Research Group, Inc
  - Granada Hills, California, United States, 91344
    - Recruiting
    - Renal Consultants Medical Group
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90095
    - Recruiting
    - UCLA Division of Nephrology
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Kaiser Permanente - Los Angeles Medical Center
  - Los Angeles, California, United States, 90022
    - Recruiting
    - Eastside Clinical Research Associates
  - Orange, California, United States, 92868
    - Recruiting
    - UCI Center for Clinical Research
  - Sacramento, California, United States, 95825
    - Recruiting
    - Kaiser Permanente, Sacramento
  - San Francisco, California, United States, 94143
    - Recruiting
    - UCSF School of Medicine
  - Torrance, California, United States, 90502
    - Recruiting
    - Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  - Victorville, California, United States, 92395
    - Recruiting
    - 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
- District of Columbia
  - Washington, District of Columbia, United States, 20037
    - Recruiting
    - The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension
- Florida
  - Bay Pines, Florida, United States, 33744
    - Recruiting
    - Bay Pines Healthcare System
  - Bradenton, Florida, United States, 34209
    - Recruiting
    - Nova Clinical Research, LLC
  - Brandon, Florida, United States, 33511-5937
    - Recruiting
    - Clinical Research of Brandon, LLC
  - Coral Gables, Florida, United States, 33134
    - Recruiting
    - Horizon Research Group, LLC
  - Coral Gables, Florida, United States, 33134
    - Recruiting
    - AMR-Miami
  - Coral Springs, Florida, United States, 33071
    - Recruiting
    - South Florida Nephrology Group PA, Research Div.
  - 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
    - Active, not recruiting
    - University of Florida, Shands Hospital
  - Hallandale Beach, Florida, United States, 33009
    - Recruiting
    - Velocity Clinical Research - Hallandale Beach
  - Hialeah, Florida, United States, 33010
    - Recruiting
    - Qway Research
  - Hollywood, Florida, United States, 33024
    - Completed
    - Elixia Pines, LLC
  - 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, 33155
    - Recruiting
    - Cordova Research Institute
  - Orlando, Florida, United States, 32808
    - Recruiting
    - Omega Research Orlando, LLC
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Elixia Central
  - Sanford, Florida, United States, 32771
    - Recruiting
    - Mid Florida Kidney and Hypertension Care, PL
  - Tampa, Florida, United States, 33618
    - Recruiting
    - Elixia Tampa, LLC
  - Tampa, Florida, United States, 33603
    - Completed
    - Genesis Clinical Research
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Children's Healthcare of Atlanta - Center for Advanced Pediatrics
  - 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, 30309
    - Recruiting
    - Advanced Clinical Research of Atlanta
  - Atlanta, Georgia, United States, 30308
    - Recruiting
    - Emory School of Medicine - Renal Division
  - Augusta, Georgia, United States, 30912-3140
    - Recruiting
    - Medical College of Georgia (MCG)
  - Brunswick, Georgia, United States, 31520
    - Recruiting
    - Coastal Medical Research
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - Renal Associates, LLC
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - Clincept - Warm Springs
  - Decatur, Georgia, United States, 30033
    - Recruiting
    - Atlanta VA Healthcare System
  - East Point, Georgia, United States, 30344
    - Recruiting
    - Southeast Kidney Associates
  - Fayetteville, Georgia, United States, 30214
    - Recruiting
    - Javara Inc./Privia Medical Group Georgia, PLLC
  - Lawrenceville, Georgia, United States, 30046
    - Recruiting
    - Georgia Nephrology
  - Savannah, Georgia, United States, 31406
    - Recruiting
    - Javara Inc./Privia Medical Group Georgia, LLC
  - Tyrone, Georgia, United States, 30290
    - Recruiting
    - Inova Clinical Trials and Research Center
- Illinois
  - Evergreen Park, Illinois, United States, 60805
    - Recruiting
    - NANI Research LLC
  - Palos Hills, Illinois, United States, 60465
    - Recruiting
    - Essential Concepts Research Solutions
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Indiana University
  - Mishawaka, Indiana, United States, 46545
    - Recruiting
    - Nephrology Physicians, LLC
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - University of Kansas Medical Center
  - 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
    - East Jefferson General Hospital
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Medical Center - New Orleans
  - New Orleans, Louisiana, United States, 70112
    - Recruiting
    - University Medical Center - New Orleans
  - New Orleans, Louisiana, United States, 70112
    - Recruiting
    - Louisiana State University Health Sciences Center LSUHSC
  - Shreveport, Louisiana, United States, 71101
    - Recruiting
    - Northwest Louisiana Nephrology, LLC - Shreveport
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Recruiting
    - Javara Inc./Privia Medical Group, LLC MidAtlantic - Main Research Site
  - Baltimore, Maryland, United States, 21287
    - Recruiting
    - Johns Hopkins Hospital
  - Baltimore, Maryland, United States, 21201
    - Completed
    - University of Maryland Medical Center
  - Gaithersburg, Maryland, United States, 20879
    - Recruiting
    - Kaiser Permanente, Mid-Atlantic
  - Silver Spring, Maryland, United States, 20901
    - Recruiting
    - Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02118
    - Recruiting
    - Boston Medical Center
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Tufts Medical 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
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Health System - A. Alfred Taubman Health Care Center - Nephrology Clinic
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Hospital
  - 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
    - Recruiting
    - InterMed Consultants
  - Minneapolis, Minnesota, United States, 55417
    - Recruiting
    - Minneapolis VA Healthcare System
- Mississippi
  - Columbus, Mississippi, United States, 39705
    - Recruiting
    - Nephrology Associates, P.C.
  - Grenada, Mississippi, United States, 38901
    - Recruiting
    - University of Mississippi
  - Tupelo, Mississippi, United States, 38801
    - Recruiting
    - Nephrology and Hypertension Associates, LTD
- Missouri
  - Saint Louis, Missouri, United States, 63136
    - Recruiting
    - St. Louis Heart and Vascular, P.C.
  - Saint Louis, Missouri, United States, 63130
    - Recruiting
    - Washington University Saint Louis
  - Saint Louis, Missouri, United States, 63104
    - Recruiting
    - Center for Specialized Medicine - SSM Health Saint Louis University Hospital
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Withdrawn
    - Nevada Kidney Disease and Hypertension Centers
  - Las Vegas, Nevada, United States, 89107
    - Recruiting
    - DaVita Clinical Research
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Hackensack University Medical Center
  - Newark, New Jersey, United States, 07103
    - Recruiting
    - Rutgers New Jersey Medical School
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Recruiting
    - New Mexico VA Healthcare System
  - Albuquerque, New Mexico, United States, 87109
    - Completed
    - Renal Medicine Associates
- New York
  - Bronx, New York, United States, 10467
    - Recruiting
    - Montefiore Medical Center
  - Bronx, New York, United States, 10468
    - Recruiting
    - James J. Peters VA Medical Center
  - Bronx, New York, United States, 10461-1900
    - Recruiting
    - Albert Einstein Hospital - Montefiore Medical Center
  - Bronx, New York, United States, 10461
    - Completed
    - Kidney Medical Associates, PLLC
  - Brooklyn, New York, United States, 11203
    - Recruiting
    - SUNY Downstate Health Sciences University
  - Flushing, New York, United States, 11365
    - Completed
    - Nephrology Associates, P.C. - Queens
  - Great Neck, New York, United States, 11021
    - Recruiting
    - Zucker School of Medicine at Hofstra/Northwell
  - Laurelton, New York, United States, 11413
    - Recruiting
    - Clinical Research Development Associates LLC
  - New York, New York, United States, 10029
    - Recruiting
    - Icahn School of Medicine at Mount Sinai
  - New York, New York, United States, 10010
    - Recruiting
    - VA New York Harbor Healthcare System
  - New York, New York, United States, 10016
    - Recruiting
    - New York University Grossman School of Medicine
  - New York, New York, United States, 10037
    - Recruiting
    - NYC Health + Hospital/Harlem
  - New York, New York, United States, 10032
    - Recruiting
    - Columbia University - Division of Nephrology
  - New York, New York, United States, 10021
    - Recruiting
    - The Rogosin Institute - The Rogosin Kidney Center
- North Carolina
  - Cary, North Carolina, United States, 27511
    - Recruiting
    - North Carolina Nephrology P.A. - Cary Office
  - 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
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - DUHS Children's Health Center T0909
  - 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
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - University Hospitals Cleveland Medical Center
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic
  - Columbus, Ohio, United States, 43201
    - Recruiting
    - Ohio State University
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19140
    - Recruiting
    - Temple University Hospital
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Thomas Jefferson University
  - Philadelphia, Pennsylvania, United States, 19141
    - Recruiting
    - Einstein Medical Center (NDKD)
  - Pittsburgh, Pennsylvania, United States, 15224
    - Recruiting
    - Children's Hospital of Pittsburgh of UPMC
- Rhode Island
  - East Providence, Rhode Island, United States, 02915
    - Recruiting
    - Lifespan Clinical Research Center
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina
  - 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
  - Nashville, Tennessee, United States, 37208
    - Recruiting
    - Meharry Medical College
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt University Medical Center, Nephrology Clinical Trials Center
- Texas
  - Arlington, Texas, United States, 76002
    - Recruiting
    - Dallas Renal Group - Arlington
  - Arlington, Texas, United States, 76015
    - Completed
    - Arlington Nephrology
  - Dallas, Texas, United States, 75204
    - Recruiting
    - Baylor Scott & White Research Institute
  - Dallas, Texas, United States, 75231
    - Recruiting
    - Nephrotex Research Group
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Dallas Renal Group - 2
  - Dallas, Texas, United States, 75237
    - Recruiting
    - Dallas Renal Group - 1
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Dallas Nephrology Associates - Dallas Landry Office
  - 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, 77054
    - Recruiting
    - Prolato Clinical Research Center
  - Houston, Texas, United States, 77054-2101
    - Recruiting
    - Ronald Ralph MD PA
  - Houston, Texas, United States, 77099
    - Recruiting
    - Southwest Houston Research, Ltd
  - Houston, Texas, United States, 77074
    - Completed
    - Houston Medical Research Institute, LLC
  - Houston, Texas, United States, 77090
    - Completed
    - Clinical Research Strategies - Romano North Main Office
  - Lewisville, Texas, United States, 75057
    - Recruiting
    - North Texas Kidney Disease Associates
  - Lubbock, Texas, United States, 79430
    - Recruiting
    - Texas Tech University Health Sciences Center
  - San Antonio, Texas, United States, 78251
    - Recruiting
    - San Antonio Kidney
  - San Antonio, Texas, United States, 78229
    - Withdrawn
    - San Antonio Kidney
  - San Antonio, Texas, United States, 78229
    - Completed
    - University of Texas Health San Antonio
  - Shenandoah, Texas, United States, 77384
    - Recruiting
    - Kidney Specialists of N Houston, PLLC
  - The Woodlands, Texas, United States, 77384
    - Recruiting
    - Renal Physicians of Montgomery County, PA
  - Webster, Texas, United States, 77598
    - Recruiting
    - Tranquil Clinical Research
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - University of Virginia Health - Nephrology Clinical Research Center
  - Norfolk, Virginia, United States, 23504
    - Recruiting
    - TKS Research, P.L.L.C.
  - Norfolk, Virginia, United States, 23504
    - Recruiting
    - York Clinical Research, LLC
  - Richmond, Virginia, United States, 23298
    - Recruiting
    - Virginia Commonwealth University - Division of Nephrology
  - Richmond, Virginia, United States, 23249
    - Recruiting
    - Richmond VAMC
  - Virginia Beach, Virginia, United States, 23454
    - Recruiting
    - Nephrology Associates of Tidewater, LTD
- Washington
  - Seattle, Washington, United States, 98195
    - Recruiting
    - University of Washington Medical Center
- Wisconsin
  - Wauwatosa, Wisconsin, United States, 53226
    - Recruiting
    - Milwaukee Nephrologists, SC

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:

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

Key Exclusion Criteria:

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

Other protocol defined Inclusion/Exclusion criteria 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: Phase 2: VX-147 Participants will be randomized to receive different dose levels of VX-147.	Drug: VX-147 Tablets for oral administration.
Placebo Comparator: Phase 2: Placebo Participants will receive placebo matched to VX-147.	Drug: Placebo Tablets for oral administration.
Experimental: Phase 3: VX-147 Participants will receive VX-147 with the dose to be based on the outcome of Phase 2.	Drug: VX-147 Tablets for oral administration.
Placebo Comparator: Phase 3: Placebo Participants will receive placebo matched to VX-147.	Drug: Placebo Tablets for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 at Week 48	From Baseline at Week 48
Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis Time Frame: From Baseline Through >= Week 48	From Baseline Through >= Week 48
eGFR Slope Assessed at Study Completion Time Frame: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)	From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Composite Clinical Outcome of a Sustained Decline of >=30 Percent (%) in eGFR, the Onset of end-stage Kidney Disease or Death Time Frame: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)	From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
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)
Maximum Plasma Concentration (Cmax) of VX-147 Time Frame: Day 1 and Week 40	Day 1 and Week 40
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
Observed Pre-dose Plasma Concentration (Ctrough) of VX-147 Time Frame: Day 1 up to Week 40	Day 1 up to Week 40
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

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)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

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 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

VX21-147-301
2021-004762-35 (EudraCT 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/independent-research/clinical-trial-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.

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

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.

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Drug Interventions

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Conditions

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