Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease 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 Genders
- 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. |
|
Placebo Comparator Phase 2: Placebo |
Participants will receive placebo matched to VX-147. |
|
Experimental Phase 3: VX-147 |
Participants will receive VX-147 with the dose to be based on the outcome of Phase 2. |
|
Placebo Comparator Phase 3: Placebo |
Participants will receive placebo matched to VX-147. |
|
Recruiting Locations
Nephrology Consultants, LLC
Huntsville, Alabama 35805
Huntsville, Alabama 35805
AKDHC Medical Research Service LLC - Banner Desert Office
Mesa, Arizona 85202
Mesa, Arizona 85202
Cardiology and Medicine Clinic, P.A.
Little Rock, Arkansas 72204
Little Rock, Arkansas 72204
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
The Medical Research Group, Inc
Fresno, California 93720
Fresno, California 93720
Renal Consultants Medical Group
Granada Hills, California 91344
Granada Hills, California 91344
Eastside Clinical Research Associates
Los Angeles, California 90022
Los Angeles, California 90022
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
UCLA Division of Nephrology
Los Angeles, California 90095
Los Angeles, California 90095
UCI Center for Clinical Research
Orange, California 92868
Orange, California 92868
Kaiser Permanente, Sacramento
Sacramento, California 95825
Sacramento, California 95825
UCSF School of Medicine
San Francisco, California 94143
San Francisco, California 94143
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
Torrance, California 90502
Kidney and Hypertension Center
Victorville, California 92395
Victorville, California 92395
Greater Hartford Nephrology
Bloomfield, Connecticut 06002
Bloomfield, Connecticut 06002
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut 06762
Middlebury, Connecticut 06762
Yale University
New Haven, Connecticut 06510
New Haven, Connecticut 06510
The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension
Washington, District of Columbia 20037
Washington, District of Columbia 20037
Bay Pines Healthcare System
Bay Pines, Florida 33744
Bay Pines, Florida 33744
Nova Clinical Research, LLC
Bradenton, Florida 34209
Bradenton, Florida 34209
Clinical Research of Brandon, LLC
Brandon, Florida 33511-5937
Brandon, Florida 33511-5937
AMR-Miami
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Horizon Research Group, LLC
Coral Gables, Florida 33134
Coral Gables, Florida 33134
South Florida Nephrology Group PA, Research Div.
Coral Springs, Florida 33071
Coral Springs, Florida 33071
Delray Physician Care Center
Delray Beach, Florida 33445
Delray Beach, Florida 33445
North Florida/South Georgia Veterans Health System
Gainesville, Florida 32608
Gainesville, Florida 32608
University of Florida, Shands Hospital
Gainesville, Florida 32610
Gainesville, Florida 32610
Velocity Clinical Research - Hallandale Beach
Hallandale Beach, Florida 33009
Hallandale Beach, Florida 33009
Qway Research
Hialeah, Florida 33010
Hialeah, Florida 33010
South Florida Research Institute
Lauderdale Lakes, Florida 33313
Lauderdale Lakes, Florida 33313
Total Research Group, LLC
Miami, Florida 33126
Miami, Florida 33126
Cordova Research Institute
Miami, Florida 33155
Miami, Florida 33155
Elixia Central
Orlando, Florida 32806
Orlando, Florida 32806
Omega Research Orlando, LLC
Orlando, Florida 32808
Orlando, Florida 32808
Mid Florida Kidney and Hypertension Care, PL
Sanford, Florida 32771
Sanford, Florida 32771
Elixia Tampa, LLC
Tampa, Florida 33618
Tampa, Florida 33618
Emory School of Medicine - Renal Division
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Advanced Clinical Research of Atlanta
Atlanta, Georgia 30309
Atlanta, Georgia 30309
Morehouse School of Medicine, Grady Memorial Hospital
Atlanta, Georgia 30310
Atlanta, Georgia 30310
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Fides Clinical Research
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Medical College of Georgia (MCG)
Augusta, Georgia 30912-3140
Augusta, Georgia 30912-3140
Coastal Medical Research
Brunswick, Georgia 31520
Brunswick, Georgia 31520
Clincept - Warm Springs
Columbus, Georgia 31904
Columbus, Georgia 31904
Renal Associates, LLC
Columbus, Georgia 31904
Columbus, Georgia 31904
Atlanta VA Healthcare System
Decatur, Georgia 30033
Decatur, Georgia 30033
Southeast Kidney Associates
East Point, Georgia 30344
East Point, Georgia 30344
Javara Inc./Privia Medical Group Georgia, PLLC
Fayetteville, Georgia 30214
Fayetteville, Georgia 30214
Georgia Nephrology
Lawrenceville, Georgia 30046
Lawrenceville, Georgia 30046
Javara Inc./Privia Medical Group Georgia, LLC
Savannah, Georgia 31406
Savannah, Georgia 31406
Inova Clinical Trials and Research Center
Tyrone, Georgia 30290
Tyrone, Georgia 30290
NANI Research LLC
Evergreen Park, Illinois 60805
Evergreen Park, Illinois 60805
Essential Concepts Research Solutions
Palos Hills, Illinois 60465
Palos Hills, Illinois 60465
Indiana University
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Nephrology Physicians, LLC
Mishawaka, Indiana 46545
Mishawaka, Indiana 46545
University of Iowa
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Renal Associates of Baton Rouge
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
East Jefferson General Hospital
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Louisiana State University Health Sciences Center LSUHSC
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
University Medical Center - New Orleans
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Ochsner Medical Center - New Orleans
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
Northwest Louisiana Nephrology, LLC - Shreveport
Shreveport, Louisiana 71101
Shreveport, Louisiana 71101
Javara Inc./Privia Medical Group, LLC MidAtlantic - Main Research Site
Annapolis, Maryland 21401
Annapolis, Maryland 21401
Johns Hopkins Hospital
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Kaiser Permanente, Mid-Atlantic
Gaithersburg, Maryland 20879
Gaithersburg, Maryland 20879
Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD
Silver Spring, Maryland 20901
Silver Spring, Maryland 20901
Tufts Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Kidney Care and Transplant Services of New England
West Springfield, Massachusetts 01089
West Springfield, Massachusetts 01089
University of Michigan Health System - A. Alfred Taubman Health Care Center - Nephrology Clinic
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
AA Medical Research Center
Flint, Michigan 48504
Flint, Michigan 48504
Sparrow Clinical Research Institute
Lansing, Michigan 48912
Lansing, Michigan 48912
Center for Advanced Kidney Research
Saint Clair Shores, Michigan 48081
Saint Clair Shores, Michigan 48081
InterMed Consultants
Edina, Minnesota 55435
Edina, Minnesota 55435
Minneapolis VA Healthcare System
Minneapolis, Minnesota 55417
Minneapolis, Minnesota 55417
Nephrology Associates, P.C.
Columbus, Mississippi 39705
Columbus, Mississippi 39705
University of Mississippi
Grenada, Mississippi 38901
Grenada, Mississippi 38901
Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi 38801
Tupelo, Mississippi 38801
Center for Specialized Medicine - SSM Health Saint Louis University Hospital
Saint Louis, Missouri 63104
Saint Louis, Missouri 63104
Washington University Saint Louis
Saint Louis, Missouri 63130
Saint Louis, Missouri 63130
St. Louis Heart and Vascular, P.C.
Saint Louis, Missouri 63136
Saint Louis, Missouri 63136
DaVita Clinical Research
Las Vegas, Nevada 89107
Las Vegas, Nevada 89107
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Rutgers New Jersey Medical School
Newark, New Jersey 07103
Newark, New Jersey 07103
New Mexico VA Healthcare System
Albuquerque, New Mexico 87108
Albuquerque, New Mexico 87108
Albert Einstein Hospital - Montefiore Medical Center
Bronx, New York 10461-1900
Bronx, New York 10461-1900
Montefiore Medical Center
Bronx, New York 10467
Bronx, New York 10467
James J. Peters VA Medical Center
Bronx, New York 10468
Bronx, New York 10468
SUNY Downstate Health Sciences University
Brooklyn, New York 11203
Brooklyn, New York 11203
Zucker School of Medicine at Hofstra/Northwell
Great Neck, New York 11021
Great Neck, New York 11021
Clinical Research Development Associates LLC
Laurelton, New York 11413
Laurelton, New York 11413
VA New York Harbor Healthcare System
New York, New York 10010
New York, New York 10010
New York University Grossman School of Medicine
New York, New York 10016
New York, New York 10016
The Rogosin Institute - The Rogosin Kidney Center
New York, New York 10021
New York, New York 10021
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
Columbia University - Division of Nephrology
New York, New York 10032
New York, New York 10032
NYC Health + Hospital/Harlem
New York, New York 10037
New York, New York 10037
North Carolina Nephrology P.A. - Cary Office
Cary, North Carolina 27511
Cary, North Carolina 27511
UNC Clinical and Translational Research Center
Chapel Hill, North Carolina 27599-7155
Chapel Hill, North Carolina 27599-7155
Metrolina Nephrology Associates
Charlotte, North Carolina 28208
Charlotte, North Carolina 28208
DUHS Children's Health Center T0909
Durham, North Carolina 27710
Durham, North Carolina 27710
Eastern Nephrology Associates - Greenville Office
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Eastern Nephrology Associates - Jacksonville Office
Jacksonville, North Carolina 28546
Jacksonville, North Carolina 28546
Eastern Nephrology Associates - Kinston Office
Kinston, North Carolina 28504
Kinston, North Carolina 28504
Eastern Nephrology Associates - New Bern Office
New Bern, North Carolina 28562
New Bern, North Carolina 28562
Eastern Nephrology Associates - Wilmington Office
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Cleveland Clinic
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Ohio State University
Columbus, Ohio 43201
Columbus, Ohio 43201
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Temple University Hospital
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Einstein Medical Center (NDKD)
Philadelphia, Pennsylvania 19141
Philadelphia, Pennsylvania 19141
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
Lifespan Clinical Research Center
East Providence, Rhode Island 02915
East Providence, Rhode Island 02915
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Columbia Nephrology Associates, PA
Columbia, South Carolina 29203
Columbia, South Carolina 29203
Carolina Nephrology, PA
Spartanburg, South Carolina 29306
Spartanburg, South Carolina 29306
Southeast Renal Research Institute
Chattanooga, Tennessee 37404
Chattanooga, Tennessee 37404
Meharry Medical College
Nashville, Tennessee 37208
Nashville, Tennessee 37208
Vanderbilt University Medical Center, Nephrology Clinical Trials Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Dallas Renal Group - Arlington
Arlington, Texas 76002
Arlington, Texas 76002
Baylor Scott & White Research Institute
Dallas, Texas 75204
Dallas, Texas 75204
Dallas Renal Group - 2
Dallas, Texas 75230
Dallas, Texas 75230
Nephrotex Research Group
Dallas, Texas 75231
Dallas, Texas 75231
Dallas Renal Group - 1
Dallas, Texas 75237
Dallas, Texas 75237
Dallas Nephrology Associates - Dallas Landry Office
Dallas, Texas 75246
Dallas, Texas 75246
UT Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
Davita Clinical Research - El Paso
El Paso, Texas 79925
El Paso, Texas 79925
Cook Children's Medical Center
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Ronald Ralph MD PA
Houston, Texas 77054-2101
Houston, Texas 77054-2101
Prolato Clinical Research Center
Houston, Texas 77054
Houston, Texas 77054
Southwest Houston Research, Ltd
Houston, Texas 77099
Houston, Texas 77099
North Texas Kidney Disease Associates
Lewisville, Texas 75057
Lewisville, Texas 75057
Texas Tech University Health Sciences Center
Lubbock, Texas 79430
Lubbock, Texas 79430
San Antonio Kidney
San Antonio, Texas 78251
San Antonio, Texas 78251
Kidney Specialists of N Houston, PLLC
Shenandoah, Texas 77384
Shenandoah, Texas 77384
Renal Physicians of Montgomery County, PA
The Woodlands, Texas 77384
The Woodlands, Texas 77384
Tranquil Clinical Research
Webster, Texas 77598
Webster, Texas 77598
University of Virginia Health - Nephrology Clinical Research Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
TKS Research, P.L.L.C.
Norfolk, Virginia 23504
Norfolk, Virginia 23504
York Clinical Research, LLC
Norfolk, Virginia 23504
Norfolk, Virginia 23504
Richmond VAMC
Richmond, Virginia 23249
Richmond, Virginia 23249
Virginia Commonwealth University - Division of Nephrology
Richmond, Virginia 23298
Richmond, Virginia 23298
Nephrology Associates of Tidewater, LTD
Virginia Beach, Virginia 23454
Virginia Beach, Virginia 23454
University of Washington Medical Center
Seattle, Washington 98195
Seattle, Washington 98195
Milwaukee Nephrologists, SC
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Alliance, School of Medicine
Rio Piedras, Puerto Rico 00935
Rio Piedras, Puerto Rico 00935
More Details
- NCT ID
- NCT05312879
- Status
- Recruiting
- Sponsor
- Vertex Pharmaceuticals Incorporated