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

Purpose

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.

Condition

Proteinuric Kidney Disease

Eligibility

Eligible Ages: Between 10 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Exclusion Criteria

Part A: - Solid organ or bone marrow transplant - Uncontrolled hypertension - History of diabetes mellitus - Known underlying cause of kidney disease including but not limited to sickle cell disease Part B: - ESKD (End Stage Kidney Disease) as defined in the protocol. - Any lab abnormality that may pose a safety risk to the participant, as judged by the investigator. Other protocol defined Inclusion/Exclusion criteria will apply.

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

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

Recruiting Locations

Alabama Kidney Research
Alabaster, Alabama 35007

EmVenio Research - Mobile Unit - Birmingham
Birmingham, Alabama 35210

Children's Hospital of Alabama
Birmingham, Alabama 35233

The Kirklin Clinic - Nephrology
Birmingham, Alabama 35294

Nephrology Associates
Fairhope, Alabama 36532

Heart Center Research LLC
Huntsville, Alabama 35801

Nephrology Consultants, LLC
Huntsville, Alabama 35805

Renal Associates of Alabama, LLC
Montgomery, Alabama 36117

Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix, Arizona 85016

Phoenix Children's Hospital, Inc. - Nephrology
Phoenix, Arizona 85016

The Medical Research Group - Saint Agnes Medical Center
Fresno, California 93720

Amicis Research Center - Balboa
Granada Hills, California 91344

Kidney Care Center of North Valley
Granada Hills, California 91344

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

UCI Center for Clinical Research
Orange, California 92868

Kaiser Permanente Sacramento Medical Center
Sacramento, California 95825

Helen Diller Medical Center at Parnassus Heights
San Francisco, California 94143

UCLA Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California 90502

Greater Hartford Nephrology
Bloomfield, Connecticut 06002

Nephrology & Hypertension Associates, PC
Middlebury, Connecticut 06762

Yale University - Yale Nephrology Clinical Research Clinic
New Haven, Connecticut 06510

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

Bay Pines Foundation
Bay Pines, Florida 33744

Nova Clinical Research, LLC - Bradenton - 59th St
Bradenton, Florida 34209

Clinical Research of Brandon, LLC
Brandon, Florida 33511

South Florida Nephrology Research
Coral Springs, Florida 33071

Delray Physician Care Center
Delray Beach, Florida 33445

North Florida/South Georgia Veterans Health System
Gainesville, Florida 32608

Shands Hospital - Nephrology
Gainesville, Florida 32610

UF Health Cardiovascular Center - Jacksonville
Jacksonville, Florida 32209

South Florida Research Institute
Lauderdale Lakes, Florida 33313

Total Research Group, LLC
Miami, Florida 33126

Cordova Research Institute
Miami, Florida 33182

South Florida Research
Miami Springs, Florida 33166

Omega Research Orlando, LLC - Mercy Dr
Orlando, Florida 32808

Infigo Clinical Research
Sanford, Florida 32771

American Clinical Trials LLC - Acworth
Acworth, Georgia 30101

Kaiser Permanente Georgia
Atlanta, Georgia 30305

Emory School of Medicine - Renal Division
Atlanta, Georgia 30308

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

Randomize Now - College Park
College Park, Georgia 30337

Clincept - Veterans Pkwy.
Columbus, Georgia 31904

Renal Associates
Columbus, Georgia 31904

Georgia Nephrology - Decatur
Decatur, Georgia 30030

Atlanta VA Healthcare System
Decatur, Georgia 30033

American Clinical Trials LLC - Douglasville
Douglasville, Georgia 30134

Southeast Kidney Associates
East Point, Georgia 30344

Javara Inc./Privia Medical Group - Fayetteville, GA
Fayetteville, Georgia 30214

Georgia Nephrology - Lawrenceville - Billing Office
Lawrenceville, Georgia 30046

Javara Inc./Privia Medical Group - Savannah, GA
Savannah, Georgia 31406

Inova Clinical Trials and Research Center
Tyrone, Georgia 30290

Rophe Adult and Pediatric Medicine
Union City, Georgia 30291

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

NANI Research LLC - Evergreen Park IL
Evergreen Park, Illinois 60805

Edward Hines Jr VA Hospital
Hines, Illinois 60141

NANI Research LLC - Fort Wayne IN
Fort Wayne, Indiana 46804

IU School of Medicine - Nephrology
Indianapolis, Indiana 46202

University of Iowa Health Care Medical Center- Nephrology
Iowa City, Iowa 52242

Renal Associates of Baton Rouge
Baton Rouge, Louisiana 70808

LCMC Health
Metairie, Louisiana 70006

University Medical Center - New Orleans - Nephrology
New Orleans, Louisiana 70112

Ochsner Medical Center - New Orleans
New Orleans, Louisiana 70121

Northwest Louisiana Nephrology, LLC
Shreveport, Louisiana 71101

Louisiana State University Health Shreveport
Shreveport, Louisiana 71103

Monroe Research, LLC
West Monroe, Louisiana 71291

Javara Inc./Privia Medical Group - Annapolis, MD
Annapolis, Maryland 21401

The Johns Hopkins University - Johns Hopkins Hospital - Nephrology
Baltimore, Maryland 21287

Mid-Atlantic Permanente Research Institute
Gaithersburg, Maryland 20879

Patient First Clinical Trials
Lutherville, Maryland 21093

MD Medical Research
Oxon Hill, Maryland 20745

Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike
Silver Spring, Maryland 20901

Tufts Medical Center
Boston, Massachusetts 02111

Boston Medical Center
Boston, Massachusetts 02118

Beth Israel Deaconess Medical Center - Nephrology
Boston, Massachusetts 02215

Whittier Street Health Center
Roxbury, Massachusetts 02120

Kidney Care and Transplant Services of New England - West Springfield
West Springfield, Massachusetts 01089

A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
Ann Arbor, Michigan 48109

Henry Ford Health System - Nephrology
Detroit, Michigan 48202

AA Medical Research Center
Flint, Michigan 48504

Sparrow Clinical Research Institute
Lansing, Michigan 48912

Center for Advanced Kidney Research
Saint Clair Shores, Michigan 48081

Minneapolis VA Healthcare System
Minneapolis, Minnesota 55417

Nephrology Associates, P.C. - Columbus
Columbus, Mississippi 39705

Prime Health and Wellness
Fayette, Mississippi 39069

Olive Branch Family Medical Center
Olive Branch, Mississippi 38654

SKY Integrative Medical Center
Ridgeland, Mississippi 39157

Nephrology and Hypertension Associates - Tupelo
Tupelo, Mississippi 38801

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

DaVita Kidney Care - Las Vegas
Las Vegas, Nevada 89107

CUH - Sheridan Pavilion - Three Cooper Plaza
Camden, New Jersey 08103

Hackensack University Medical Center
Hackensack, New Jersey 07601

Bioluminux Clinical Research New Jersey
Hamilton, New Jersey 08690

Jersey Shore University Medical Center
Neptune City, New Jersey 07753

Rutgers Doctors Office Center
Newark, New Jersey 07103

Kings County Hospital
Brooklyn, New York 11203

SUNY Downstate Health Sciences University
Brooklyn, New York 11203

New York Presbyterian Queens
Flushing, New York 11365

Zucker School of Medicine
Great Neck, New York 11021

Scott Research, Inc.
Laurelton, New York 11413

Grossman School of Medicine
New York, New York 10016

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

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

North Carolina Nephrology P.A. - Cary
Cary, North Carolina 27511

UNC Clinical and Translational Research Center
Chapel Hill, North Carolina 27599-7155

Metrolina Nephrology Associates - Freedom Dr
Charlotte, North Carolina 28208

Duke University Hospital - Children's Health Center
Durham, North Carolina 27710

Eastern Nephrology Associates - Greenville Office
Greenville, North Carolina 27834

Eastern Nephrology Associates - Jacksonville Office
Jacksonville, North Carolina 28546

Eastern Nephrology Associates - Kinston Office
Kinston, North Carolina 28504

Eastern Nephrology Associates - New Bern Office
New Bern, North Carolina 28562

Eastern Nephrology Associates - Wilmington Office
Wilmington, North Carolina 28401

UC - DCI McMillan Research Unit
Cincinnati, Ohio 45206

Louis Stokes Cleveland VA medical Center
Cleveland, Ohio 44106

UH Cleveland Medical Center - Nephrology
Cleveland, Ohio 44106

Cleveland Clinic - Main Campus
Cleveland, Ohio 44195

Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit
Columbus, Ohio 43201

Lewis Katz School of Medicine at Temple University - Section of Nephrology
Philadelphia, Pennsylvania 19140

Jefferson Einstein Philadelphia Hospital - Nephrology
Philadelphia, Pennsylvania 19141

Lifespan Clinical Research Center
East Providence, Rhode Island 02915

Pharmacorp Clinical Trials, Inc
Charleston, South Carolina 29412

Medical University of South Carolina - Pulmonology
Charleston, South Carolina 29425

Columbia Nephrology Associates, PA
Columbia, South Carolina 29203

Carolina Nephrology, PA
Spartanburg, South Carolina 29306

Southeast Renal Research Institute
Chattanooga, Tennessee 37404

Le Bonheur Children's Hospital - Outpatient Clinic
Memphis, Tennessee 38105

CNS Healthcare - Memphis
Memphis, Tennessee 38119

Nashville General Hospital - Meharry Medical College - Nephrology
Nashville, Tennessee 37208

Nashville VA Medical Center
Nashville, Tennessee 37212

Nephrology Clinical Trials Center
Nashville, Tennessee 37232

Baylor Scott and White Research Institute - Nephrology
Dallas, Texas 75204

Dallas Renal Group- Dallas
Dallas, Texas 75230

Zenos Clinical Research
Dallas, Texas 75230

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

Davita Clinical Research - El Paso
El Paso, Texas 79925

Cook Children's Medical Center
Fort Worth, Texas 76104

Prolato Clinical Research Center - Kirby Dr
Houston, Texas 77054

Ronald Ralph MD PA
Houston, Texas 77054

Prime Clinical Research Inc - Lewisville
Lewisville, Texas 75067

Texas Tech University Health Sciences Center
Lubbock, Texas 79430

Prime Clinical Research - Mansfield - Regency Parkway
Mansfield, Texas 76063

Kidney Specialists of N Houston, PLLC
Shenandoah, Texas 77384

Renal Research of Montgomery County, PLLC
The Woodlands, Texas 77384

Tranquil Clinical Research
Webster, Texas 77598

UVA Health - Nephrology Clinical Research Center
Charlottesville, Virginia 22908

Tidewater Kidney Specialists - Church St.
Norfolk, Virginia 23504

McGuire Research Institute, Inc. (151)
Richmond, Virginia 23249

Virginia Commonwealth University - Division of Nephrology
Richmond, Virginia 23298

UW Medical Center - Montlake - Nephrology
Seattle, Washington 98195

Medical College of Wisconsin - Pulmonology
Milwaukee, Wisconsin 53226

Milwaukee Nephrologists - Wauwatosa
Wauwatosa, Wisconsin 53226

FDI Clinical Research
Mayagüez, Puerto Rico 06680

University of Puerto Rico
Rio Piedras, Puerto Rico 00935

More Details

NCT ID: NCT05312879
Status: Recruiting
Sponsor: Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.