UAMS - Translational Research Institute

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

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

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 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 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.

Recruiting Locations

Alabama Kidney Research
Alabaster 4829762, Alabama 4829764 35007

EmVenio Research - Mobile Unit - Birmingham
Birmingham 4049979, Alabama 4829764 35210

Cardiology, P.C.
Birmingham 4049979, Alabama 4829764 35211

Children's Hospital of Alabama
Birmingham 4049979, Alabama 4829764 35233

The Kirklin Clinic - Nephrology
Birmingham 4049979, Alabama 4829764 35294

Nephrology Associates
Fairhope 4061234, Alabama 4829764 36532

Heart Center Research LLC
Huntsville 4068590, Alabama 4829764 35801

Nephrology Consultants, LLC
Huntsville 4068590, Alabama 4829764 35805

Renal Associates of Alabama, LLC
Montgomery 4076784, Alabama 4829764 36117

Phoenix Children's Hospital, Inc. - Nephrology
Phoenix 5308655, Arizona 5551752 85016

UAMS Medical Center - Pulmonology
Little Rock 4119403, Arkansas 4099753 72205

The Medical Research Group - Saint Agnes Medical Center
Fresno 5350937, California 5332921 93720

Amicis Research Center - Balboa
Granada Hills 5353433, California 5332921 91344

Kidney Care Center of North Valley
Granada Hills 5353433, California 5332921 91344

Eastside Clinical Research Associates
Los Angeles 5368361, California 5332921 90022

Kaiser Permanente Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90027

Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048

UCI Center for Clinical Research
Orange 5379513, California 5332921 92868

Kaiser Permanente Sacramento Medical Center
Sacramento 5389489, California 5332921 95825

Helen Diller Medical Center at Parnassus Heights
San Francisco 5391959, California 5332921 94143

UCLA Lundquist Institute at Harbor-UCLA Medical Center
Torrance 5403022, California 5332921 90502

Greater Hartford Nephrology
Bloomfield 5282526, Connecticut 4831725 06002

Nephrology & Hypertension Associates, PC
Middlebury 4838611, Connecticut 4831725 06762

Yale University - Yale Nephrology Clinical Research Clinic
New Haven 4839366, Connecticut 4831725 06510

Children's National Hospital - Nephrology
Washington D.C. 4140963, District of Columbia 4138106 20010

The George Washington University - GW Medical Faculty Associates
Washington D.C. 4140963, District of Columbia 4138106 20037

Veterans Affairs Medical Center - Washington D.C
Washington D.C. 4140963, District of Columbia 4138106 20422

Bay Pines Foundation
Bay Pines 4146855, Florida 4155751 33744

Nova Clinical Research, LLC - Bradenton - 59th St
Bradenton 4148708, Florida 4155751 34209

Clinical Research of Brandon, LLC
Brandon 4148757, Florida 4155751 33511

AMR-Miami
Coral Gables 4151871, Florida 4155751 33134

South Florida Nephrology Research
Coral Springs 4151909, Florida 4155751 33071

Delray Physician Care Center
Delray Beach 4153132, Florida 4155751 33445

North Florida/South Georgia Veterans Health System
Gainesville 4156404, Florida 4155751 32608

Shands Hospital - Nephrology
Gainesville 4156404, Florida 4155751 32610

Velocity Clinical Research - Hallandale Beach
Hallandale 4157898, Florida 4155751 33009

UF Health Cardiovascular Center - Jacksonville
Jacksonville 4160021, Florida 4155751 32209

South Florida Research Institute
Lauderdale Lakes 4161616, Florida 4155751 33313

Total Research Group, LLC
Miami 4164138, Florida 4155751 33126

Cordova Research Institute
Miami 4164138, Florida 4155751 33182

South Florida Research
Miami Springs 4164223, Florida 4155751 33166

Omega Research Orlando, LLC - Mercy Dr
Orlando 4167147, Florida 4155751 32808

Infigo Clinical Research
Sanford 4172086, Florida 4155751 32771

American Clinical Trials LLC - Acworth
Acworth 4179074, Georgia 4197000 30101

Kaiser Permanente Georgia
Atlanta 4180439, Georgia 4197000 30305

Emory School of Medicine - Renal Division
Atlanta 4180439, Georgia 4197000 30308

Advanced Clinical Research of Atlanta
Atlanta 4180439, Georgia 4197000 30309

Morehouse School of Medicine, Grady Memorial Hospital
Atlanta 4180439, Georgia 4197000 30310

Emory Childrens Center - Nephrology
Atlanta 4180439, Georgia 4197000 30322

Synexus Clinical Research - Atlanta (DRS)
Atlanta 4180439, Georgia 4197000 30328

Fides Clinical Research
Atlanta 4180439, Georgia 4197000 30342

Augusta University Medical College of Georgia - Adult Sickle Cell Clinic
Augusta 4180531, Georgia 4197000 30912

Randomize Now - College Park
College Park 4188815, Georgia 4197000 30337

Clincept - Veterans Pkwy.
Columbus 4188985, Georgia 4197000 31904

Renal Associates
Columbus 4188985, Georgia 4197000 31904

Georgia Nephrology - Decatur
Decatur 4191124, Georgia 4197000 30030

Atlanta VA Healthcare System
Decatur 4191124, Georgia 4197000 30033

American Clinical Trials LLC - Douglasville
Douglasville 4191955, Georgia 4197000 30134

Southeast Kidney Associates
East Point 4192674, Georgia 4197000 30344

Javara Inc./Privia Medical Group - Fayetteville, GA
Fayetteville 4194474, Georgia 4197000 30214

Georgia Nephrology - Lawrenceville - Billing Office
Lawrenceville 4205196, Georgia 4197000 30046

Javara Inc./Privia Medical Group - Savannah, GA
Savannah 4221552, Georgia 4197000 31406

Inova Clinical Trials and Research Center
Tyrone 4227612, Georgia 4197000 30290

Rophe Adult and Pediatric Medicine
Union City 4227777, Georgia 4197000 30291

Synexus Clinical Research - Chicago (DRS)
Chicago 4887398, Illinois 4896861 60602

EmVenio Research - Chicago
Chicago 4887398, Illinois 4896861 60608

Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology
Chicago 4887398, Illinois 4896861 60611-2605

Northwestern Medical Group
Chicago 4887398, Illinois 4896861 60611

UChicago Medicine - Comer Children's Hospital
Chicago 4887398, Illinois 4896861 60637

NANI Research LLC - Evergreen Park IL
Evergreen Park 4891431, Illinois 4896861 60805

Edward Hines Jr VA Hospital
Hines 4896005, Illinois 4896861 60141

NANI Research LLC - Fort Wayne IN
Fort Wayne 4920423, Indiana 4921868 46804

IU School of Medicine - Nephrology
Indianapolis 4259418, Indiana 4921868 46202

University of Iowa Health Care Medical Center- Nephrology
Iowa City 4862034, Iowa 4862182 52242

Clinical & Translational Science Unit (CTSU) - Nephrology
Kansas City 4273837, Kansas 4273857 66160

Renal Associates of Baton Rouge
Baton Rouge 4315588, Louisiana 4331987 70808

LCMC Health
Metairie 4333177, Louisiana 4331987 70006

Barnum Medical Research - Bienville St
Natchitoches 4334720, Louisiana 4331987 71457

University Medical Center - New Orleans - Nephrology
New Orleans 4335045, Louisiana 4331987 70112

Ochsner Medical Center - New Orleans
New Orleans 4335045, Louisiana 4331987 70121

Northwest Louisiana Nephrology, LLC
Shreveport 4341513, Louisiana 4331987 71101

Louisiana State University Health Shreveport
Shreveport 4341513, Louisiana 4331987 71103

Monroe Research, LLC
West Monroe 4345850, Louisiana 4331987 71291

Javara Inc./Privia Medical Group - Annapolis, MD
Annapolis 4347242, Maryland 4361885 21401

The Johns Hopkins University - Johns Hopkins Hospital - Nephrology
Baltimore 4347778, Maryland 4361885 21287

Mid-Atlantic Permanente Research Institute
Gaithersburg 4355843, Maryland 4361885 20879

Patient First Clinical Trials
Lutherville 4361379, Maryland 4361885 21093

MD Medical Research
Oxon Hill 4364759, Maryland 4361885 20745

Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike
Silver Spring 4369596, Maryland 4361885 20901

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118

Beth Israel Deaconess Medical Center - Nephrology
Boston 4930956, Massachusetts 6254926 02215

Whittier Street Health Center
Roxbury 4949151, Massachusetts 6254926 02120

Kidney Care and Transplant Services of New England - West Springfield
West Springfield 4955089, Massachusetts 6254926 01089

A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
Ann Arbor 4984247, Michigan 5001836 48109

Henry Ford Health System - Nephrology
Detroit 4990729, Michigan 5001836 48202

Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334

AA Medical Research Center
Flint 4992982, Michigan 5001836 48504

Sparrow Clinical Research Institute
Lansing 4998830, Michigan 5001836 48912

Center for Advanced Kidney Research
Saint Clair Shores 5010978, Michigan 5001836 48081

Minneapolis VA Healthcare System
Minneapolis 5037649, Minnesota 5037779 55417

Nephrology Associates, P.C. - Columbus
Columbus 4422442, Mississippi 4436296 39705

Prime Health and Wellness
Fayette 4426218, Mississippi 4436296 39069

G.V. (Sonny) Montgomery VAMC
Jackson 4431410, Mississippi 4436296 39216

Olive Branch Family Medical Center
Olive Branch 4439869, Mississippi 4436296 38654

SKY Integrative Medical Center
Ridgeland 4443296, Mississippi 4436296 39157

Nephrology and Hypertension Associates - Tupelo
Tupelo 4448903, Mississippi 4436296 38801

Barnes-Jewish Center for Outpatient Health
St Louis 4407066, Missouri 4398678 63108

St. Louis Children's Hospital - Nephrology
St Louis 4407066, Missouri 4398678 63110

St. Louis Heart and Vascular, P.C.
St Louis 4407066, Missouri 4398678 63136

DaVita Kidney Care - Las Vegas
Las Vegas 5506956, Nevada 5509151 89107

CUH - Sheridan Pavilion - Three Cooper Plaza
Camden 4501018, New Jersey 5101760 08103

Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601

Bioluminux Clinical Research New Jersey
Hamilton 5098765, New Jersey 5101760 08690

Jersey Shore University Medical Center
Neptune City 5101687, New Jersey 5101760 07753

Rutgers Doctors Office Center
Newark 5101798, New Jersey 5101760 07103

Kings County Hospital
Brooklyn 5110302, New York 5128638 11203

SUNY Downstate Health Sciences University
Brooklyn 5110302, New York 5128638 11203

New York Presbyterian Queens
Flushing 5117472, New York 5128638 11365

Zucker School of Medicine
Great Neck 5119218, New York 5128638 11021

Scott Research, Inc.
Laurelton 5124078, New York 5128638 11413

VA New York Harbor Healthcare System
New York 5128581, New York 5128638 10010

Grossman School of Medicine
New York 5128581, New York 5128638 10016

The Rogosin Kidney Center
New York 5128581, New York 5128638 10021

Icahn School of Medicine at Mount Sinai - Nephrology
New York 5128581, New York 5128638 10029

General Nephrology Clinic - New York City
New York 5128581, New York 5128638 10032

NYC Health + Hospital/Harlem
New York 5128581, New York 5128638 10037

Montefiore Einstein - Albert Einstein College of Medicine
The Bronx 5110266, New York 5128638 10461

Montefiore Einstein Hospital - Moses Campus
The Bronx 5110266, New York 5128638 10467

James J. Peters VA Medical Center
The Bronx 5110266, New York 5128638 10468

North Carolina Nephrology P.A. - Cary
Cary 4459467, North Carolina 4482348 27511

UNC Clinical and Translational Research Center
Chapel Hill 4460162, North Carolina 4482348 27599-7155

Metrolina Nephrology Associates - Freedom Dr
Charlotte 4460243, North Carolina 4482348 28208

Duke University Hospital - Children's Health Center
Durham 4464368, North Carolina 4482348 27710

Eastern Nephrology Associates - Greenville Office
Greenville 4469160, North Carolina 4482348 27834

Eastern Nephrology Associates - Jacksonville Office
Jacksonville 4473083, North Carolina 4482348 28546

Eastern Nephrology Associates - Kinston Office
Kinston 4474436, North Carolina 4482348 28504

Eastern Nephrology Associates - New Bern Office
New Bern 4481682, North Carolina 4482348 28562

Eastern Nephrology Associates - Wilmington Office
Wilmington 4499379, North Carolina 4482348 28401

UC - DCI McMillan Research Unit
Cincinnati 4508722, Ohio 5165418 45206

Louis Stokes Cleveland VA medical Center
Cleveland 5150529, Ohio 5165418 44106

UH Cleveland Medical Center - Nephrology
Cleveland 5150529, Ohio 5165418 44106

Cleveland Clinic - Main Campus
Cleveland 5150529, Ohio 5165418 44195

Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit
Columbus 4509177, Ohio 5165418 43201

Jefferson Health - 33 South 9th Street
Philadelphia 4560349, Pennsylvania 6254927 19107

Lewis Katz School of Medicine at Temple University - Section of Nephrology
Philadelphia 4560349, Pennsylvania 6254927 19140

Jefferson Einstein Philadelphia Hospital - Nephrology
Philadelphia 4560349, Pennsylvania 6254927 19141

Lifespan Clinical Research Center
East Providence 5221931, Rhode Island 5224323 02915

Pharmacorp Clinical Trials, Inc
Charleston 4574324, South Carolina 4597040 29412

Medical University of South Carolina - Pulmonology
Charleston 4574324, South Carolina 4597040 29425

Columbia Nephrology Associates, PA
Columbia 4575352, South Carolina 4597040 29203

Carolina Nephrology, PA
Spartanburg 4597200, South Carolina 4597040 29306

Southeast Renal Research Institute
Chattanooga 4612862, Tennessee 4662168 37404

Le Bonheur Children's Hospital - Outpatient Clinic
Memphis 4641239, Tennessee 4662168 38105

CNS Healthcare - Memphis
Memphis 4641239, Tennessee 4662168 38119

Nashville General Hospital - Meharry Medical College - Nephrology
Nashville 4644585, Tennessee 4662168 37208

Nashville VA Medical Center
Nashville 4644585, Tennessee 4662168 37212

Nephrology Clinical Trials Center
Nashville 4644585, Tennessee 4662168 37232

Baylor Scott and White Research Institute - Nephrology
Dallas 4684888, Texas 4736286 75204

Dallas Renal Group- Dallas
Dallas 4684888, Texas 4736286 75230

Zenos Clinical Research
Dallas 4684888, Texas 4736286 75230

Dallas Renal Group - Liberty Dallas Dialysis Center
Dallas 4684888, Texas 4736286 75237

Dallas Nephrology Associates - Dallas Landry Office
Dallas 4684888, Texas 4736286 75246

Southwest Family Medicine Associates (SFMA) - Dallas
Dallas 4684888, Texas 4736286 75325

UTSW Medical Center - Nephrology
Dallas 4684888, Texas 4736286 75390

Davita Clinical Research - El Paso
El Paso 5520993, Texas 4736286 79925

Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286 76104

Prolato Clinical Research Center - Kirby Dr
Houston 4699066, Texas 4736286 77054

Ronald Ralph MD PA
Houston 4699066, Texas 4736286 77054

NTKDA Lewisville
Lewisville 4706057, Texas 4736286 75057

Prime Clinical Research Inc - Lewisville
Lewisville 4706057, Texas 4736286 75067

Texas Tech University Health Sciences Center
Lubbock 5525577, Texas 4736286 79430

Prime Clinical Research - Mansfield - Regency Parkway
Mansfield 4709013, Texas 4736286 76063

Kidney Specialists of N Houston, PLLC
Shenandoah 4728287, Texas 4736286 77384

Renal Research of Montgomery County, PLLC
The Woodlands 4736476, Texas 4736286 77384

Tranquil Clinical Research
Webster 4740423, Texas 4736286 77598

UVA Health - Nephrology Clinical Research Center
Charlottesville 4752031, Virginia 6254928 22908

Tidewater Kidney Specialists - Church St.
Norfolk 4776222, Virginia 6254928 23504

McGuire Research Institute, Inc. (151)
Richmond 4781708, Virginia 6254928 23249

Virginia Commonwealth University - Division of Nephrology
Richmond 4781708, Virginia 6254928 23298

UW Medical Center - Montlake - Nephrology
Seattle 5809844, Washington 5815135 98195

Medical College of Wisconsin - Pulmonology
Milwaukee 5263045, Wisconsin 5279468 53226

Milwaukee Nephrologists - Wauwatosa
Wauwatosa 5278159, Wisconsin 5279468 53226

FDI Clinical Research
Mayagüez 4566385, Puerto Rico 06680

University of Puerto Rico
Rio Piedras 4829037, 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.