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. |
|
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
Alabama Kidney Research
Alabaster, Alabama 35007
Alabaster, Alabama 35007
EmVenio Research - Mobile Unit - Birmingham
Birmingham, Alabama 35210
Birmingham, Alabama 35210
Cardiology, P.C.
Birmingham, Alabama 35211
Birmingham, Alabama 35211
Children's Hospital of Alabama
Birmingham, Alabama 35233
Birmingham, Alabama 35233
The Kirklin Clinic - Nephrology
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Nephrology Associates
Fairhope, Alabama 36532
Fairhope, Alabama 36532
Heart Center Research LLC
Huntsville, Alabama 35801
Huntsville, Alabama 35801
Nephrology Consultants, LLC
Huntsville, Alabama 35805
Huntsville, Alabama 35805
Renal Associates of Alabama, LLC
Montgomery, Alabama 36117
Montgomery, Alabama 36117
Phoenix Children's Hospital, Inc. - Nephrology
Phoenix, Arizona 85016
Phoenix, Arizona 85016
UAMS Medical Center - Pulmonology
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
The Medical Research Group - Saint Agnes Medical Center
Fresno, California 93720
Fresno, California 93720
Amicis Research Center - Balboa
Granada Hills, California 91344
Granada Hills, California 91344
Kidney Care Center of North Valley
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
UCI Center for Clinical Research
Orange, California 92868
Orange, California 92868
Kaiser Permanente Sacramento Medical Center
Sacramento, California 95825
Sacramento, California 95825
Helen Diller Medical Center at Parnassus Heights
San Francisco, California 94143
San Francisco, California 94143
UCLA Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California 90502
Torrance, California 90502
Greater Hartford Nephrology
Bloomfield, Connecticut 06002
Bloomfield, Connecticut 06002
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut 06762
Middlebury, Connecticut 06762
Yale University - Yale Nephrology Clinical Research Clinic
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Children's National Hospital - Nephrology
Washington, District of Columbia 20010
Washington, District of Columbia 20010
The George Washington University - GW Medical Faculty Associates
Washington, District of Columbia 20037
Washington, District of Columbia 20037
Bay Pines Foundation
Bay Pines, Florida 33744
Bay Pines, Florida 33744
Nova Clinical Research, LLC - Bradenton - 59th St
Bradenton, Florida 34209
Bradenton, Florida 34209
Clinical Research of Brandon, LLC
Brandon, Florida 33511
Brandon, Florida 33511
AMR-Miami
Coral Gables, Florida 33134
Coral Gables, Florida 33134
South Florida Nephrology Research
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
Shands Hospital - Nephrology
Gainesville, Florida 32610
Gainesville, Florida 32610
Velocity Clinical Research - Hallandale Beach
Hallandale Beach, Florida 33009
Hallandale Beach, Florida 33009
UF Health Cardiovascular Center - Jacksonville
Jacksonville, Florida 32209
Jacksonville, Florida 32209
South Florida Research Institute
Lauderdale Lakes, Florida 33313
Lauderdale Lakes, Florida 33313
South Florida Research
Miami Springs, Florida 33166
Miami Springs, Florida 33166
Total Research Group, LLC
Miami, Florida 33126
Miami, Florida 33126
Cordova Research Institute
Miami, Florida 33182
Miami, Florida 33182
Omega Research Orlando, LLC - Mercy Dr
Orlando, Florida 32808
Orlando, Florida 32808
Infigo Clinical Research
Sanford, Florida 32771
Sanford, Florida 32771
American Clinical Trials LLC - Acworth
Acworth, Georgia 30101
Acworth, Georgia 30101
Kaiser Permanente Georgia
Atlanta, Georgia 30305
Atlanta, Georgia 30305
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
Emory Childrens Center - Nephrology
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Synexus Clinical Research - Atlanta (DRS)
Atlanta, Georgia 30328
Atlanta, Georgia 30328
Fides Clinical Research
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Augusta University Medical College of Georgia - Adult Sickle Cell Clinic
Augusta, Georgia 30912
Augusta, Georgia 30912
Randomize Now - College Park
College Park, Georgia 30337
College Park, Georgia 30337
Clincept - Veterans Pkwy.
Columbus, Georgia 31904
Columbus, Georgia 31904
Renal Associates
Columbus, Georgia 31904
Columbus, Georgia 31904
Georgia Nephrology - Decatur
Decatur, Georgia 30030
Decatur, Georgia 30030
Atlanta VA Healthcare System
Decatur, Georgia 30033
Decatur, Georgia 30033
American Clinical Trials LLC - Douglasville
Douglasville, Georgia 30134
Douglasville, Georgia 30134
Southeast Kidney Associates
East Point, Georgia 30344
East Point, Georgia 30344
Javara Inc./Privia Medical Group - Fayetteville, GA
Fayetteville, Georgia 30214
Fayetteville, Georgia 30214
Georgia Nephrology - Lawrenceville - Billing Office
Lawrenceville, Georgia 30046
Lawrenceville, Georgia 30046
Javara Inc./Privia Medical Group - Savannah, GA
Savannah, Georgia 31406
Savannah, Georgia 31406
Inova Clinical Trials and Research Center
Tyrone, Georgia 30290
Tyrone, Georgia 30290
Rophe Adult and Pediatric Medicine
Union City, Georgia 30291
Union City, Georgia 30291
Synexus Clinical Research - Chicago (DRS)
Chicago, Illinois 60602
Chicago, Illinois 60602
EmVenio Research - Chicago
Chicago, Illinois 60608
Chicago, Illinois 60608
Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology
Chicago, Illinois 60611-2605
Chicago, Illinois 60611-2605
Northwestern Medical Group
Chicago, Illinois 60611
Chicago, Illinois 60611
UChicago Medicine - Comer Children's Hospital
Chicago, Illinois 60637
Chicago, Illinois 60637
NANI Research LLC - Evergreen Park IL
Evergreen Park, Illinois 60805
Evergreen Park, Illinois 60805
Edward Hines Jr VA Hospital
Hines, Illinois 60141
Hines, Illinois 60141
NANI Research LLC - Fort Wayne IN
Fort Wayne, Indiana 46804
Fort Wayne, Indiana 46804
IU School of Medicine - Nephrology
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
University of Iowa Health Care Medical Center- Nephrology
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Clinical & Translational Science Unit (CTSU) - Nephrology
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Renal Associates of Baton Rouge
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
LCMC Health
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Barnum Medical Research - Bienville St
Natchitoches, Louisiana 71457
Natchitoches, Louisiana 71457
University Medical Center - New Orleans - Nephrology
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, Louisiana 71101
Shreveport, Louisiana 71101
Louisiana State University Health Shreveport
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
Monroe Research, LLC
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
Javara Inc./Privia Medical Group - Annapolis, MD
Annapolis, Maryland 21401
Annapolis, Maryland 21401
The Johns Hopkins University - Johns Hopkins Hospital - Nephrology
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Mid-Atlantic Permanente Research Institute
Gaithersburg, Maryland 20879
Gaithersburg, Maryland 20879
Patient First Clinical Trials
Lutherville, Maryland 21093
Lutherville, Maryland 21093
MD Medical Research
Oxon Hill, Maryland 20745
Oxon Hill, Maryland 20745
Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike
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 - Nephrology
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Whittier Street Health Center
Roxbury, Massachusetts 02120
Roxbury, Massachusetts 02120
Kidney Care and Transplant Services of New England - West Springfield
West Springfield, Massachusetts 01089
West Springfield, Massachusetts 01089
A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Henry Ford Health System - Nephrology
Detroit, Michigan 48202
Detroit, Michigan 48202
Quest Research Institute
Farmington Hills, Michigan 48334
Farmington Hills, Michigan 48334
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
Minneapolis VA Healthcare System
Minneapolis, Minnesota 55417
Minneapolis, Minnesota 55417
Nephrology Associates, P.C. - Columbus
Columbus, Mississippi 39705
Columbus, Mississippi 39705
Prime Health and Wellness
Fayette, Mississippi 39069
Fayette, Mississippi 39069
G.V. (Sonny) Montgomery VAMC
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Olive Branch Family Medical Center
Olive Branch, Mississippi 38654
Olive Branch, Mississippi 38654
SKY Integrative Medical Center
Ridgeland, Mississippi 39157
Ridgeland, Mississippi 39157
Nephrology and Hypertension Associates - Tupelo
Tupelo, Mississippi 38801
Tupelo, Mississippi 38801
Barnes-Jewish Center for Outpatient Health
Saint Louis, Missouri 63108
Saint Louis, Missouri 63108
St. Louis Children's Hospital - Nephrology
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
St. Louis Heart and Vascular, P.C.
Saint Louis, Missouri 63136
Saint Louis, Missouri 63136
DaVita Kidney Care - Las Vegas
Las Vegas, Nevada 89107
Las Vegas, Nevada 89107
CUH - Sheridan Pavilion - Three Cooper Plaza
Camden, New Jersey 08103
Camden, New Jersey 08103
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Bioluminux Clinical Research New Jersey
Hamilton, New Jersey 08690
Hamilton, New Jersey 08690
Jersey Shore University Medical Center
Neptune, New Jersey 07753
Neptune, New Jersey 07753
Rutgers Doctors Office Center
Newark, New Jersey 07103
Newark, New Jersey 07103
New Mexico VA Healthcare System
Albuquerque, New Mexico 87108
Albuquerque, New Mexico 87108
Montefiore Einstein - Albert Einstein College of Medicine
Bronx, New York 10461
Bronx, New York 10461
Montefiore Einstein Hospital - Moses Campus
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
New York Presbyterian Queens
Flushing, New York 11365
Flushing, New York 11365
Zucker School of Medicine
Great Neck, New York 11021
Great Neck, New York 11021
Scott Research, Inc.
Laurelton, New York 11413
Laurelton, New York 11413
VA New York Harbor Healthcare System
New York, New York 10010
New York, New York 10010
Grossman School of Medicine
New York, New York 10016
New York, New York 10016
The Rogosin Kidney Center
New York, New York 10021
New York, New York 10021
Icahn School of Medicine at Mount Sinai - Nephrology
New York, New York 10029
New York, New York 10029
General Nephrology Clinic - New York City
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
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 - Freedom Dr
Charlotte, North Carolina 28208
Charlotte, North Carolina 28208
Duke University Hospital - Children's Health Center
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
UC - DCI McMillan Research Unit
Cincinnati, Ohio 45206
Cincinnati, Ohio 45206
Louis Stokes Cleveland VA medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
UH Cleveland Medical Center - Nephrology
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Cleveland Clinic - Main Campus
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit
Columbus, Ohio 43201
Columbus, Ohio 43201
Jefferson Health - 33 South 9th Street
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Lewis Katz School of Medicine at Temple University - Section of Nephrology
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Jefferson Einstein Philadelphia Hospital - Nephrology
Philadelphia, Pennsylvania 19141
Philadelphia, Pennsylvania 19141
Lifespan Clinical Research Center
East Providence, Rhode Island 02915
East Providence, Rhode Island 02915
Pharmacorp Clinical Trials, Inc
Charleston, South Carolina 29412
Charleston, South Carolina 29412
Medical University of South Carolina - Pulmonology
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
Le Bonheur Children's Hospital - Outpatient Clinic
Memphis, Tennessee 38105
Memphis, Tennessee 38105
CNS Healthcare - Memphis
Memphis, Tennessee 38119
Memphis, Tennessee 38119
Nashville General Hospital - Meharry Medical College - Nephrology
Nashville, Tennessee 37208
Nashville, Tennessee 37208
Nashville VA Medical Center
Nashville, Tennessee 37212
Nashville, Tennessee 37212
Nephrology Clinical Trials Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Baylor Scott and White Research Institute - Nephrology
Dallas, Texas 75204
Dallas, Texas 75204
Dallas Renal Group- Dallas
Dallas, Texas 75230
Dallas, Texas 75230
Zenos Clinical Research
Dallas, Texas 75230
Dallas, Texas 75230
Dallas Renal Group - Liberty Dallas Dialysis Center
Dallas, Texas 75237
Dallas, Texas 75237
Dallas Nephrology Associates - Dallas Landry Office
Dallas, Texas 75246
Dallas, Texas 75246
Southwest Family Medicine Associates (SFMA) - Dallas
Dallas, Texas 75325
Dallas, Texas 75325
UTSW Medical Center - Nephrology
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
Prolato Clinical Research Center - Kirby Dr
Houston, Texas 77054
Houston, Texas 77054
Ronald Ralph MD PA
Houston, Texas 77054
Houston, Texas 77054
NTKDA Lewisville
Lewisville, Texas 75057
Lewisville, Texas 75057
Prime Clinical Research Inc - Lewisville
Lewisville, Texas 75067
Lewisville, Texas 75067
Texas Tech University Health Sciences Center
Lubbock, Texas 79430
Lubbock, Texas 79430
Prime Clinical Research - Mansfield - Regency Parkway
Mansfield, Texas 76063
Mansfield, Texas 76063
Kidney Specialists of N Houston, PLLC
Shenandoah, Texas 77384
Shenandoah, Texas 77384
Renal Research of Montgomery County, PLLC
The Woodlands, Texas 77384
The Woodlands, Texas 77384
Tranquil Clinical Research
Webster, Texas 77598
Webster, Texas 77598
UVA Health - Nephrology Clinical Research Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Tidewater Kidney Specialists - Church St.
Norfolk, Virginia 23504
Norfolk, Virginia 23504
McGuire Research Institute, Inc. (151)
Richmond, Virginia 23249
Richmond, Virginia 23249
Virginia Commonwealth University - Division of Nephrology
Richmond, Virginia 23298
Richmond, Virginia 23298
UW Medical Center - Montlake - Nephrology
Seattle, Washington 98195
Seattle, Washington 98195
Medical College of Wisconsin - Pulmonology
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Milwaukee Nephrologists - Wauwatosa
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
FDI Clinical Research
Mayaguez, Puerto Rico 06680
Mayaguez, Puerto Rico 06680
University of Puerto Rico
Rio Piedras, Puerto Rico 00935
Rio Piedras, Puerto Rico 00935
More Details
- NCT ID
- NCT05312879
- Status
- Recruiting
- Sponsor
- Vertex Pharmaceuticals Incorporated