Recruiting
Phase 2
Phase 3

VX-147

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT05312879

Conditions

Proteinuric Kidney Disease

Eligibility Criteria

Sex: All

Age: 10 - 65

Healthy Volunteers: Not accepted

Interventions

VX-147

Placebo

Study Details

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.

Conditions

Proteinuric Kidney Disease

Study ID

NCT05312879

Start date

Mar 30, 2022

Status verified date

Aug, 2026

Completion date

May 7, 2030

Anticipated

Primary completion date

Jun 2, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

466 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

placebo comparator: Part A (Phase 2/3): Placebo

Participants will receive placebo matched to VX-147.

experimental: Part B (Phase 3): VX-147

Participants who complete Part A will receive VX-147 for an additional 96 weeks.

Interventions

VX-147

Tablets for oral administration.

Placebo

Tablets for oral administration.

Primary outcome measure

  • Part A: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis) [ Time Frame: From Baseline to Week 48 ]
  • Part A: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at Interim Analysis [ Time Frame: From Baseline Through >= Week 48 ]
  • Part A: eGFR Slope Assessed at Final Analysis [ Time Frame: 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) [ Time Frame: Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls) ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

Alabama Kidney Research

Recruiting

Alabaster, Alabama, United States, 35007

EmVenio Research - Mobile Unit - Birmingham

Recruiting

Birmingham, Alabama, United States, 35210

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

The Kirklin Clinic - Nephrology

Recruiting

Birmingham, Alabama, United States, 35294

Nephrology Associates

Recruiting

Fairhope, Alabama, United States, 36532

Heart Center Research LLC

Recruiting

Huntsville, Alabama, United States, 35801

Nephrology Consultants, LLC

Recruiting

Huntsville, Alabama, United States, 35805

Renal Associates of Alabama, LLC

Recruiting

Montgomery, Alabama, United States, 36117

Arizona Kidney Disease and Hypertension Center - Thomas Office

Recruiting

Phoenix, Arizona, United States, 85016

The Medical Research Group - Saint Agnes Medical Center

Recruiting

Fresno, California, United States, 93720

Amicis Research Center - Balboa

Recruiting

Granada Hills, California, United States, 91344

Kidney Care Center of North Valley

Recruiting

Granada Hills, California, United States, 91344

Eastside Clinical Research Associates

Recruiting

Los Angeles, California, United States, 90022

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

UCI Center for Clinical Research

Recruiting

Orange, California, United States, 92868

Kaiser Permanente Sacramento Medical Center

Recruiting

Sacramento, California, United States, 95825

Helen Diller Medical Center at Parnassus Heights

Recruiting

San Francisco, California, United States, 94143

UCLA Lundquist Institute at Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Greater Hartford Nephrology

Recruiting

Bloomfield, Connecticut, United States, 06002

Nephrology & Hypertension Associates, PC

Recruiting

Middlebury, Connecticut, United States, 06762

Yale University - Yale Nephrology Clinical Research Clinic

Recruiting

New Haven, Connecticut, United States, 06510

Children's National Hospital - Nephrology

Recruiting

Washington D.C., District of Columbia, United States, 20010

The George Washington University - GW Medical Faculty Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Veterans Affairs Medical Center - Washington D.C

Recruiting

Washington D.C., District of Columbia, United States, 20422

Bay Pines Foundation

Recruiting

Bay Pines, Florida, United States, 33744

Nova Clinical Research, LLC - Bradenton - 59th St

Recruiting

Bradenton, Florida, United States, 34209

Clinical Research of Brandon, LLC

Recruiting

Brandon, Florida, United States, 33511

South Florida Nephrology Research

Recruiting

Coral Springs, Florida, United States, 33071

Delray Physician Care Center

Recruiting

Delray Beach, Florida, United States, 33445

North Florida/South Georgia Veterans Health System

Recruiting

Gainesville, Florida, United States, 32608

Shands Hospital - Nephrology

Recruiting

Gainesville, Florida, United States, 32610

UF Health Cardiovascular Center - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

South Florida Research Institute

Recruiting

Lauderdale Lakes, Florida, United States, 33313

Total Research Group, LLC

Recruiting

Miami, Florida, United States, 33126

Cordova Research Institute

Recruiting

Miami, Florida, United States, 33182

South Florida Research

Recruiting

Miami Springs, Florida, United States, 33166

CTR Oakwater, LLC

Recruiting

Orlando, Florida, United States, 32806

Omega Research Orlando, LLC - Mercy Dr

Recruiting

Orlando, Florida, United States, 32808

Infigo Clinical Research

Recruiting

Sanford, Florida, United States, 32771

American Clinical Trials LLC - Acworth

Recruiting

Acworth, Georgia, United States, 30101

Kaiser Permanente Georgia

Recruiting

Atlanta, Georgia, United States, 30305

Emory School of Medicine - Renal Division

Recruiting

Atlanta, Georgia, United States, 30308

Emory Childrens Center - Nephrology

Recruiting

Atlanta, Georgia, United States, 30322

Synexus Clinical Research - Atlanta (DRS)

Recruiting

Atlanta, Georgia, United States, 30328

Fides Clinical Research

Recruiting

Atlanta, Georgia, United States, 30342

Augusta University Medical College of Georgia - Adult Sickle Cell Clinic

Recruiting

Augusta, Georgia, United States, 30912

Randomize Now - College Park

Recruiting

College Park, Georgia, United States, 30337

Clincept - Veterans Pkwy.

Recruiting

Columbus, Georgia, United States, 31904

Renal Associates

Recruiting

Columbus, Georgia, United States, 31904

Georgia Nephrology - Decatur

Recruiting

Decatur, Georgia, United States, 30030

American Clinical Trials LLC - Douglasville

Recruiting

Douglasville, Georgia, United States, 30134

Southeast Kidney Associates

Recruiting

East Point, Georgia, United States, 30344

Javara Inc./Privia Medical Group - Fayetteville, GA

Recruiting

Fayetteville, Georgia, United States, 30214

Georgia Nephrology - Lawrenceville - Billing Office

Recruiting

Lawrenceville, Georgia, United States, 30046

Javara Inc./Privia Medical Group - Savannah, GA

Recruiting

Savannah, Georgia, United States, 31406

Rophe Adult and Pediatric Medicine

Recruiting

Union City, Georgia, United States, 30291

EmVenio Research - Chicago

Recruiting

Chicago, Illinois, United States, 60608

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

Recruiting

Chicago, Illinois, United States, 60611-2605

Northwestern Medical Group

Recruiting

Chicago, Illinois, United States, 60611

UChicago Medicine - Comer Children's Hospital

Recruiting

Chicago, Illinois, United States, 60637

NANI Research LLC - Evergreen Park IL

Recruiting

Evergreen Park, Illinois, United States, 60805

Edward Hines Jr VA Hospital

Recruiting

Hines, Illinois, United States, 60141

NANI Research LLC - Fort Wayne IN

Recruiting

Fort Wayne, Indiana, United States, 46804

IU School of Medicine - Nephrology

Recruiting

Indianapolis, Indiana, United States, 46202

University of Iowa Health Care Medical Center- Nephrology

Recruiting

Iowa City, Iowa, United States, 52242

Renal Associates of Baton Rouge

Recruiting

Baton Rouge, Louisiana, United States, 70808

LCMC Health

Recruiting

Metairie, Louisiana, United States, 70006

University Medical Center - New Orleans - Nephrology

Recruiting

New Orleans, Louisiana, United States, 70112

Ochsner Medical Center - New Orleans

Recruiting

New Orleans, Louisiana, United States, 70121

Northwest Louisiana Nephrology, LLC

Recruiting

Shreveport, Louisiana, United States, 71101

Louisiana State University Health Shreveport

Recruiting

Shreveport, Louisiana, United States, 71103

Monroe Research, LLC

Recruiting

West Monroe, Louisiana, United States, 71291

The Johns Hopkins University - Johns Hopkins Hospital - Nephrology

Recruiting

Baltimore, Maryland, United States, 21287

Mid-Atlantic Permanente Research Institute

Recruiting

Gaithersburg, Maryland, United States, 20879

Patient First Clinical Trials

Recruiting

Lutherville, Maryland, United States, 21093

MD Medical Research

Recruiting

Oxon Hill, Maryland, United States, 20745

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

Recruiting

Silver Spring, Maryland, United States, 20901

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Beth Israel Deaconess Medical Center - Nephrology

Recruiting

Boston, Massachusetts, United States, 02215

Whittier Street Health Center

Recruiting

Roxbury, Massachusetts, United States, 02120

Kidney Care and Transplant Services of New England - West Springfield

Recruiting

West Springfield, Massachusetts, United States, 01089

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

Recruiting

Ann Arbor, Michigan, United States, 48109

Henry Ford Health System - Nephrology

Recruiting

Detroit, Michigan, United States, 48202

AA Medical Research Center

Recruiting

Flint, Michigan, United States, 48504

Sparrow Clinical Research Institute

Recruiting

Lansing, Michigan, United States, 48912

Center for Advanced Kidney Research

Recruiting

Saint Clair Shores, Michigan, United States, 48081

Nephrology Associates, P.C. - Columbus

Recruiting

Columbus, Mississippi, United States, 39705

Prime Health and Wellness

Recruiting

Fayette, Mississippi, United States, 39069

Olive Branch Family Medical Center

Recruiting

Olive Branch, Mississippi, United States, 38654

SKY Integrative Medical Center

Recruiting

Ridgeland, Mississippi, United States, 39157

Nephrology and Hypertension Associates - Tupelo

Recruiting

Tupelo, Mississippi, United States, 38801

Barnes-Jewish Center for Outpatient Health

Recruiting

St Louis, Missouri, United States, 63108

St. Louis Children's Hospital - Nephrology

Recruiting

St Louis, Missouri, United States, 63110

St. Louis Heart and Vascular, P.C.

Recruiting

St Louis, Missouri, United States, 63136

DaVita Kidney Care - Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89107

CUH - Sheridan Pavilion - Three Cooper Plaza

Recruiting

Camden, New Jersey, United States, 08103

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Bioluminux Clinical Research New Jersey

Recruiting

Hamilton, New Jersey, United States, 08690

Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Rutgers Doctors Office Center

Recruiting

Newark, New Jersey, United States, 07103

Kings County Hospital

Recruiting

Brooklyn, New York, United States, 11203

SUNY Downstate Health Sciences University

Recruiting

Brooklyn, New York, United States, 11203

New York Presbyterian Queens

Recruiting

Flushing, New York, United States, 11365

Zucker School of Medicine

Recruiting

Great Neck, New York, United States, 11021

Scott Research, Inc.

Recruiting

Laurelton, New York, United States, 11413

Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

The Rogosin Kidney Center

Recruiting

New York, New York, United States, 10021

Icahn School of Medicine at Mount Sinai - Nephrology

Recruiting

New York, New York, United States, 10029

General Nephrology Clinic - New York City

Recruiting

New York, New York, United States, 10032

NYC Health + Hospital/Harlem

Recruiting

New York, New York, United States, 10037

Montefiore Einstein - Albert Einstein College of Medicine

Recruiting

The Bronx, New York, United States, 10461

Montefiore Einstein Hospital - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

James J. Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

North Carolina Nephrology P.A. - Cary

Recruiting

Cary, North Carolina, United States, 27511

UNC Clinical and Translational Research Center

Recruiting

Chapel Hill, North Carolina, United States, 27599-7155

Metrolina Nephrology Associates - Freedom Dr

Recruiting

Charlotte, North Carolina, United States, 28208

Duke University Hospital - Children's Health Center

Recruiting

Durham, North Carolina, United States, 27710

Eastern Nephrology Associates - Greenville Office

Recruiting

Greenville, North Carolina, United States, 27834

Eastern Nephrology Associates - Jacksonville Office

Recruiting

Jacksonville, North Carolina, United States, 28546

Eastern Nephrology Associates - Kinston Office

Recruiting

Kinston, North Carolina, United States, 28504

Eastern Nephrology Associates - New Bern Office

Recruiting

New Bern, North Carolina, United States, 28562

Eastern Nephrology Associates - Wilmington Office

Recruiting

Wilmington, North Carolina, United States, 28401

UC - DCI McMillan Research Unit

Recruiting

Cincinnati, Ohio, United States, 45206

Louis Stokes Cleveland VA medical Center

Recruiting

Cleveland, Ohio, United States, 44106

UH Cleveland Medical Center - Nephrology

Recruiting

Cleveland, Ohio, United States, 44106

Cleveland Clinic - Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

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

Recruiting

Columbus, Ohio, United States, 43201

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

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Jefferson Einstein Philadelphia Hospital - Nephrology

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Children's Hospital of Pittsburgh - Nephrology

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Lifespan Clinical Research Center

Recruiting

East Providence, Rhode Island, United States, 02915

Pharmacorp Clinical Trials, Inc

Recruiting

Charleston, South Carolina, United States, 29412

Medical University of South Carolina - Pulmonology

Recruiting

Charleston, South Carolina, United States, 29425

Columbia Nephrology Associates, PA

Recruiting

Columbia, South Carolina, United States, 29203

Carolina Nephrology, PA

Recruiting

Spartanburg, South Carolina, United States, 29306

Southeast Renal Research Institute

Recruiting

Chattanooga, Tennessee, United States, 37404

Le Bonheur Children's Hospital - Outpatient Clinic

Recruiting

Memphis, Tennessee, United States, 38105

CNS Healthcare - Memphis

Recruiting

Memphis, Tennessee, United States, 38119

Nashville General Hospital - Meharry Medical College - Nephrology

Recruiting

Nashville, Tennessee, United States, 37208

Nephrology Clinical Trials Center

Recruiting

Nashville, Tennessee, United States, 37232

Baylor Scott and White Research Institute - Nephrology

Recruiting

Dallas, Texas, United States, 75204

Dallas Renal Group- Dallas

Recruiting

Dallas, Texas, United States, 75230

Zenos Clinical Research

Recruiting

Dallas, Texas, United States, 75230

Dallas Renal Group - Liberty Dallas Dialysis Center

Recruiting

Dallas, Texas, United States, 75237

Dallas Nephrology Associates - Dallas Landry Office

Recruiting

Dallas, Texas, United States, 75246

Southwest Family Medicine Associates (SFMA) - Dallas

Recruiting

Dallas, Texas, United States, 75325

UTSW Medical Center - Nephrology

Recruiting

Dallas, Texas, United States, 75390

Davita Clinical Research - El Paso

Recruiting

El Paso, Texas, United States, 79925

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Prolato Clinical Research Center - Kirby Dr

Recruiting

Houston, Texas, United States, 77054

Prime Clinical Research Inc - Lewisville

Recruiting

Lewisville, Texas, United States, 75067

Texas Tech University Health Sciences Center

Recruiting

Lubbock, Texas, United States, 79430

Prime Clinical Research - Mansfield - Regency Parkway

Recruiting

Mansfield, Texas, United States, 76063

Kidney Specialists of N Houston, PLLC

Recruiting

Shenandoah, Texas, United States, 77384

Renal Research of Montgomery County, PLLC

Recruiting

The Woodlands, Texas, United States, 77384

Tranquil Clinical Research

Recruiting

Webster, Texas, United States, 77598

UVA Health - Nephrology Clinical Research Center

Recruiting

Charlottesville, Virginia, United States, 22908

Tidewater Kidney Specialists - Church St.

Recruiting

Norfolk, Virginia, United States, 23504

McGuire Research Institute, Inc. (151)

Recruiting

Richmond, Virginia, United States, 23249

Virginia Commonwealth University - Division of Nephrology

Recruiting

Richmond, Virginia, United States, 23298

UW Medical Center - Montlake - Nephrology

Recruiting

Seattle, Washington, United States, 98195

Medical College of Wisconsin - Pulmonology

Recruiting

Milwaukee, Wisconsin, United States, 53226

Milwaukee Nephrologists - Wauwatosa

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Women's College Hospital

Recruiting

Toronto, Canada

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • APOL1-mediated kidney disease (AMKD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-08-26.