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

RecruitingPhase 2/3

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

Who can join

Ages 10 to 65 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Vertex Pharmaceuticals Incorporated · Participants: 466 · Started: Mar 30, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05312879

Locations in the U.S.

AlabamaAlabama Kidney Research, Alabaster
EmVenio Research - Mobile Unit - Birmingham, Birmingham
The Kirklin Clinic - Nephrology, Birmingham
Nephrology Associates, Fairhope
Heart Center Research LLC, Huntsville
Nephrology Consultants, LLC, Huntsville
Renal Associates of Alabama, LLC, Montgomery
ArizonaArizona Kidney Disease and Hypertension Center - Thomas Office, Phoenix
CaliforniaAmicis Research Center - Balboa, Granada Hills
Kidney Care Center of North Valley, Granada Hills
Cedars-Sinai Medical Center, Los Angeles
Eastside Clinical Research Associates, Los Angeles
Kaiser Permanente Los Angeles Medical Center, Los Angeles
Kaiser Permanente Sacramento Medical Center, Sacramento
Helen Diller Medical Center at Parnassus Heights, San Francisco
ConnecticutGreater Hartford Nephrology, Bloomfield
Yale University - Yale Nephrology Clinical Research Clinic, New Haven
District of ColumbiaThe George Washington University - GW Medical Faculty Associates, Washington D.C.
Veterans Affairs Medical Center - Washington D.C, Washington D.C.
FloridaBay Pines Foundation, Bay Pines
Nova Clinical Research, LLC - Bradenton - 59th St, Bradenton
South Florida Nephrology Research, Coral Springs
Delray Physician Care Center, Delray Beach
North Florida/South Georgia Veterans Health System, Gainesville
UF Health Cardiovascular Center - Jacksonville, Jacksonville
South Florida Research Institute, Lauderdale Lakes
Cordova Research Institute, Miami
Total Research Group, LLC, Miami
South Florida Research, Miami Springs
CTR Oakwater, LLC, Orlando
Omega Research Orlando, LLC - Mercy Dr, Orlando
Infigo Clinical Research, Sanford
GeorgiaAmerican Clinical Trials LLC - Acworth, Acworth
Emory Childrens Center - Nephrology, Atlanta
Emory School of Medicine - Renal Division, Atlanta
Fides Clinical Research, Atlanta
Kaiser Permanente Georgia, Atlanta
Augusta University Medical College of Georgia - Adult Sickle Cell Clinic, Augusta
Randomize Now - College Park, College Park
Clincept - Veterans Pkwy., Columbus
Renal Associates, Columbus
Georgia Nephrology - Decatur, Decatur
American Clinical Trials LLC - Douglasville, Douglasville
Southeast Kidney Associates, East Point
Georgia Nephrology - Lawrenceville - Billing Office, Lawrenceville
Javara Inc./Privia Medical Group - Savannah, GA, Savannah
Rophe Adult and Pediatric Medicine, Union City
IllinoisAnn & Robert H. Lurie Children's Hospital of Chicago - Nephrology, Chicago
EmVenio Research - Chicago, Chicago
Northwestern Medical Group, Chicago
UChicago Medicine - Comer Children's Hospital, Chicago
NANI Research LLC - Evergreen Park IL, Evergreen Park
Edward Hines Jr VA Hospital, Hines
IndianaNANI Research LLC - Fort Wayne IN, Fort Wayne
IowaUniversity of Iowa Health Care Medical Center- Nephrology, Iowa City
LouisianaRenal Associates of Baton Rouge, Baton Rouge
Ochsner Medical Center - New Orleans, New Orleans
University Medical Center - New Orleans - Nephrology, New Orleans
Louisiana State University Health Shreveport, Shreveport
Northwest Louisiana Nephrology, LLC, Shreveport
Monroe Research, LLC, West Monroe
MarylandThe Johns Hopkins University - Johns Hopkins Hospital - Nephrology, Baltimore
Mid-Atlantic Permanente Research Institute, Gaithersburg
Patient First Clinical Trials, Lutherville
MD Medical Research, Oxon Hill
MassachusettsBeth Israel Deaconess Medical Center - Nephrology, Boston
Boston Medical Center, Boston
Tufts Medical Center, Boston
Whittier Street Health Center, Roxbury
Kidney Care and Transplant Services of New England - West Springfield, West Springfield
MichiganA. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center, Ann Arbor
Henry Ford Health System - Nephrology, Detroit
AA Medical Research Center, Flint
Center for Advanced Kidney Research, Saint Clair Shores
MississippiNephrology Associates, P.C. - Columbus, Columbus
Prime Health and Wellness, Fayette
SKY Integrative Medical Center, Ridgeland
Nephrology and Hypertension Associates - Tupelo, Tupelo
MissouriSt. Louis Children's Hospital - Nephrology, St Louis
St. Louis Heart and Vascular, P.C., St Louis
NevadaDaVita Kidney Care - Las Vegas, Las Vegas
New JerseyHackensack University Medical Center, Hackensack
Bioluminux Clinical Research New Jersey, Hamilton
Rutgers Doctors Office Center, Newark
New YorkKings County Hospital, Brooklyn
New York Presbyterian Queens, Flushing
Scott Research, Inc., Laurelton
General Nephrology Clinic - New York City, New York
Icahn School of Medicine at Mount Sinai - Nephrology, New York
NYC Health + Hospital/Harlem, New York
The Rogosin Kidney Center, New York
James J. Peters VA Medical Center, The Bronx
Montefiore Einstein - Albert Einstein College of Medicine, The Bronx
North CarolinaNorth Carolina Nephrology P.A. - Cary, Cary
UNC Clinical and Translational Research Center, Chapel Hill
Metrolina Nephrology Associates - Freedom Dr, Charlotte
Duke University Hospital - Children's Health Center, Durham
Eastern Nephrology Associates - Greenville Office, Greenville
Eastern Nephrology Associates - Kinston Office, Kinston
Eastern Nephrology Associates - New Bern Office, New Bern
Eastern Nephrology Associates - Wilmington Office, Wilmington
OhioUC - DCI McMillan Research Unit, Cincinnati
Louis Stokes Cleveland VA medical Center, Cleveland
UH Cleveland Medical Center - Nephrology, Cleveland
Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit, Columbus
PennsylvaniaJefferson Einstein Philadelphia Hospital - Nephrology, Philadelphia
Lewis Katz School of Medicine at Temple University - Section of Nephrology, Philadelphia
Children's Hospital of Pittsburgh - Nephrology, Pittsburgh
Rhode IslandLifespan Clinical Research Center, East Providence
South CarolinaMedical University of South Carolina - Pulmonology, Charleston
Columbia Nephrology Associates, PA, Columbia
Carolina Nephrology, PA, Spartanburg
TennesseeLe Bonheur Children's Hospital - Outpatient Clinic, Memphis
Nephrology Clinical Trials Center, Nashville
TexasBaylor Scott and White Research Institute - Nephrology, Dallas
Dallas Nephrology Associates - Dallas Landry Office, Dallas
Dallas Renal Group - Liberty Dallas Dialysis Center, Dallas
Southwest Family Medicine Associates (SFMA) - Dallas, Dallas
UTSW Medical Center - Nephrology, Dallas
Zenos Clinical Research, Dallas
Davita Clinical Research - El Paso, El Paso
Cook Children's Medical Center, Fort Worth
Prolato Clinical Research Center - Kirby Dr, Houston
Prime Clinical Research Inc - Lewisville, Lewisville
Texas Tech University Health Sciences Center, Lubbock
Prime Clinical Research - Mansfield - Regency Parkway, Mansfield
Kidney Specialists of N Houston, PLLC, Shenandoah
Renal Research of Montgomery County, PLLC, The Woodlands
Tranquil Clinical Research, Webster
VirginiaUVA Health - Nephrology Clinical Research Center, Charlottesville
Tidewater Kidney Specialists - Church St., Norfolk
McGuire Research Institute, Inc. (151), Richmond
Virginia Commonwealth University - Division of Nephrology, Richmond
WashingtonUW Medical Center - Montlake - Nephrology, Seattle

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.