Proteinuric Kidney Disease Clinical Trial
— AMPLITUDEOfficial title:
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
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.
| Status | Recruiting |
| Enrollment | 466 |
| Est. completion date | June 2026 |
| Est. primary completion date | May 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 65 Years |
| Eligibility | Key Inclusion Criteria: - APOL1 genotype of G1/G1, G2/G2, or G1/G2 - Proteinuric kidney disease Key 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Leuven | Leuven | |
| Belgium | Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Brussels |
| Brazil | Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte | |
| Brazil | Instituto Pro-Renal | Curitiba | |
| Brazil | PUC Trials - Unidade Epicenter | Curitiba | |
| Brazil | Hospital Universitário Valter Cantídio | Fortaleza | |
| Brazil | Federal University of Goiás (UFG) | Goiania | |
| Brazil | Cmip-Centro Mineiro de Pesquisa Ltda | Juiz de Fora | |
| Brazil | Galileo Medical Research Ltda | Juiz De Fora | |
| Brazil | Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | |
| Brazil | UFRS - Hospital de Clínicas | Porto Alegre | |
| Brazil | Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo | Ribeirao Preto | |
| Brazil | Hospital São Lucas | Rio de Janeiro | |
| Brazil | Hospital Universitário Pedro Ernesto | Rio de Janeiro | |
| Brazil | Pedro Ernesto University Hospital | Rio de Janeiro | |
| Brazil | CSB Group of Nephrology Brazil | Salvador | |
| Brazil | Federal University of Bahia | Salvador | |
| Brazil | Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto | |
| Brazil | Hospital do Rim - Fundação Oswaldo Ramos - Ambulatorio NEFRITE | São Paulo | |
| Brazil | University of Sao Paulo | São Paulo | |
| Canada | Recherche GCP Research | Montreal | |
| Canada | Women's College Hospital | Toronto | |
| Colombia | Clinica de La Costa S.A.S | Atlántico | |
| Colombia | Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO | Bogota | |
| Colombia | Fundación Valle Del Lili | Cali | |
| Colombia | Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS | Cartagena | |
| Colombia | Fundación Hospitalaria San Vicente de Paul | Medellín | |
| France | Hopital Henri Mondor | Créteil | |
| France | CHU Grenoble Alpes - Hôpital Nord Michallon | Grenoble | |
| France | Hôpital Bicêtre AP-HP | Le Kremlin Bicêtre | |
| France | CHU Dupuytren 2 | Limoges | |
| France | Hôpital de la Conception, Centre de néphrologie et transplantation rénale | Marseille | |
| France | Ambroise Paré Hospital | Paris | |
| France | Hopitaux Universitaires Est Parisien - Hopital Tenon | Paris | |
| France | Service de Nephrologie - Hopital Universitaire Necker | Paris | |
| France | Université Paris-Descartes / Hôpital Européen Georges Pompidou | Paris | |
| France | AURA Nord Saint Ouen | Saint-Ouen | |
| France | Centre Hospitalier Universitaire CHU de Toulouse Hopital de Rangueil | Toulouse | |
| Ghana | University of Ghana Medical School | Accra | |
| Ghana | The Bank Hospital | Cantonments | |
| Ghana | Komfo Anokye Teaching Hospital | Kumasi | |
| Netherlands | University of Amsterdam | Amsterdam | |
| Portugal | Unidade Autónoma de Nefrologia | Amadora | |
| Portugal | Department of Nephrology and Renal Transplant | Lisboa | |
| Portugal | Hospital Curry Cabral | Lisboa | |
| Portugal | Hospital Beatriz Angelo | Loures | |
| Puerto Rico | Alliance, School of Medicine | Rio Piedras | |
| Puerto Rico | GCM Medical Group, PSC | San Juan | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Reina Sofia University Hospital | Córdoba | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Virgen Macarena | Seville | |
| United Kingdom | FutureMeds Birmingham | Birmingham | |
| United Kingdom | University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital | Birmingham | |
| United Kingdom | Epsom and St Helier University Hospitals NHS Trust - St Helier Hospital - South West SW Thames Institute for Renal Research | Carshalton | |
| United Kingdom | University Hospitals of Leicester NHS Trust - Leicester General Hospital | Leicester | |
| United Kingdom | Barts Health NHS Trust, The Royal London Hospital | London | |
| United Kingdom | Guy's & St Thomas NHS Foundation Trust, Guy's Hospital | London | |
| United Kingdom | Royal Free NHS Trust | London | |
| United Kingdom | St George's University Hospitals NHS Foundation Trust | London | |
| United Kingdom | Manchester Royal Infirmary | Manchester | |
| United Kingdom | The Medicines Evaluation Unit | Manchester | |
| United Kingdom | Nottingham University Hospital | Nottingham | |
| United Kingdom | King's College Hospital NHS Foundation Trust - Guthrie Clinic | Southwark | |
| United States | New Mexico VA Healthcare System | Albuquerque | New Mexico |
| United States | Renal Medicine Associates | Albuquerque | New Mexico |
| United States | University of Michigan Health System - A. Alfred Taubman Health Care Center - Nephrology Clinic | Ann Arbor | Michigan |
| United States | Javara Inc./Privia Medical Group, LLC MidAtlantic - Main Research Site | Annapolis | Maryland |
| United States | Arlington Nephrology | Arlington | Texas |
| United States | Dallas Renal Group - Arlington | Arlington | Texas |
| United States | Advanced Clinical Research of Atlanta | Atlanta | Georgia |
| United States | Children's Healthcare of Atlanta - Center for Advanced Pediatrics | Atlanta | Georgia |
| United States | Emory School of Medicine - Renal Division | Atlanta | Georgia |
| United States | Fides Clinical Research | Atlanta | Georgia |
| United States | Morehouse School of Medicine, Grady Memorial Hospital | Atlanta | Georgia |
| United States | Medical College of Georgia (MCG) | Augusta | Georgia |
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | Renal Associates of Baton Rouge | Baton Rouge | Louisiana |
| United States | Bay Pines Healthcare System | Bay Pines | Florida |
| United States | Greater Hartford Nephrology | Bloomfield | Connecticut |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Nova Clinical Research, LLC | Bradenton | Florida |
| United States | Clinical Research of Brandon, LLC | Brandon | Florida |
| United States | Albert Einstein Hospital - Montefiore Medical Center | Bronx | New York |
| United States | James J. Peters VA Medical Center | Bronx | New York |
| United States | Kidney Medical Associates, PLLC | Bronx | New York |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | SUNY Downstate Health Sciences University | Brooklyn | New York |
| United States | Coastal Medical Research | Brunswick | Georgia |
| United States | North Carolina Nephrology P.A. - Cary Office | Cary | North Carolina |
| United States | UNC Clinical and Translational Research Center | Chapel Hill | North Carolina |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Metrolina Nephrology Associates | Charlotte | North Carolina |
| United States | University of Virginia Health - Nephrology Clinical Research Center | Charlottesville | Virginia |
| United States | Southeast Renal Research Institute | Chattanooga | Tennessee |
| United States | Cincinnati VA Medical Center | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Columbia Nephrology Associates, PA | Columbia | South Carolina |
| United States | Clincept - Warm Springs | Columbus | Georgia |
| United States | Nephrology Associates, P.C. | Columbus | Mississippi |
| United States | Ohio State University | Columbus | Ohio |
| United States | Renal Associates, LLC | Columbus | Georgia |
| United States | AMR-Miami | Coral Gables | Florida |
| United States | Horizon Research Group, LLC | Coral Gables | Florida |
| United States | South Florida Nephrology Group PA, Research Div. | Coral Springs | Florida |
| United States | Baylor Scott & White Research Institute | Dallas | Texas |
| United States | Dallas Nephrology Associates - Dallas Landry Office | Dallas | Texas |
| United States | Dallas Renal Group - 1 | Dallas | Texas |
| United States | Dallas Renal Group - 2 | Dallas | Texas |
| United States | Nephrotex Research Group | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Atlanta VA Healthcare System | Decatur | Georgia |
| United States | Delray Physician Care Center | Delray Beach | Florida |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | DUHS Children's Health Center T0909 | Durham | North Carolina |
| United States | Southeast Kidney Associates | East Point | Georgia |
| United States | Lifespan Clinical Research Center | East Providence | Rhode Island |
| United States | InterMed Consultants | Edina | Minnesota |
| United States | Davita Clinical Research - El Paso | El Paso | Texas |
| United States | NANI Research LLC | Evergreen Park | Illinois |
| United States | Nephrology Associates | Fairhope | Alabama |
| United States | Javara Inc./Privia Medical Group Georgia, PLLC | Fayetteville | Georgia |
| United States | AA Medical Research Center | Flint | Michigan |
| United States | Nephrology Associates, P.C. - Queens | Flushing | New York |
| United States | Cook Children's Medical Center | Fort Worth | Texas |
| United States | The Medical Research Group, Inc | Fresno | California |
| United States | North Florida/South Georgia Veterans Health System | Gainesville | Florida |
| United States | University of Florida, Shands Hospital | Gainesville | Florida |
| United States | Kaiser Permanente, Mid-Atlantic | Gaithersburg | Maryland |
| United States | Renal Consultants Medical Group | Granada Hills | California |
| United States | Zucker School of Medicine at Hofstra/Northwell | Great Neck | New York |
| United States | Eastern Nephrology Associates - Greenville Office | Greenville | North Carolina |
| United States | University of Mississippi | Grenada | Mississippi |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Velocity Clinical Research - Hallandale Beach | Hallandale Beach | Florida |
| United States | Qway Research | Hialeah | Florida |
| United States | Elixia Pines, LLC | Hollywood | Florida |
| United States | Clinical Research Strategies - Romano North Main Office | Houston | Texas |
| United States | Houston Medical Research Institute, LLC | Houston | Texas |
| United States | Prolato Clinical Research Center | Houston | Texas |
| United States | Ronald Ralph MD PA | Houston | Texas |
| United States | Southwest Houston Research, Ltd | Houston | Texas |
| United States | Nephrology Consultants, LLC | Huntsville | Alabama |
| United States | Indiana University | Indianapolis | Indiana |
| United States | University of Iowa | Iowa City | Iowa |
| United States | Eastern Nephrology Associates - Jacksonville Office | Jacksonville | North Carolina |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Eastern Nephrology Associates - Kinston Office | Kinston | North Carolina |
| United States | Sparrow Clinical Research Institute | Lansing | Michigan |
| United States | DaVita Clinical Research | Las Vegas | Nevada |
| United States | Nevada Kidney Disease and Hypertension Centers | Las Vegas | Nevada |
| United States | South Florida Research Institute | Lauderdale Lakes | Florida |
| United States | Clinical Research Development Associates LLC | Laurelton | New York |
| United States | Georgia Nephrology | Lawrenceville | Georgia |
| United States | North Texas Kidney Disease Associates | Lewisville | Texas |
| United States | Cardiology and Medicine Clinic, P.A. | Little Rock | Arkansas |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Eastside Clinical Research Associates | Los Angeles | California |
| United States | Kaiser Permanente - Los Angeles Medical Center | Los Angeles | California |
| United States | UCLA Division of Nephrology | Los Angeles | California |
| United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
| United States | AKDHC Medical Research Service LLC - Banner Desert Office | Mesa | Arizona |
| United States | East Jefferson General Hospital | Metairie | Louisiana |
| United States | Cordova Research Institute | Miami | Florida |
| United States | MedBio Trials | Miami | Florida |
| United States | Total Research Group, LLC | Miami | Florida |
| United States | Nephrology & Hypertension Associates, PC | Middlebury | Connecticut |
| United States | Minneapolis VA Healthcare System | Minneapolis | Minnesota |
| United States | Nephrology Physicians, LLC | Mishawaka | Indiana |
| United States | Meharry Medical College | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center, Nephrology Clinical Trials Center | Nashville | Tennessee |
| United States | Eastern Nephrology Associates - New Bern Office | New Bern | North Carolina |
| United States | Yale University | New Haven | Connecticut |
| United States | Louisiana State University Health Sciences Center LSUHSC | New Orleans | Louisiana |
| United States | Ochsner Medical Center - New Orleans | New Orleans | Louisiana |
| United States | University Medical Center - New Orleans | New Orleans | Louisiana |
| United States | Columbia University - Division of Nephrology | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | New York University Grossman School of Medicine | New York | New York |
| United States | NYC Health + Hospital/Harlem | New York | New York |
| United States | The Rogosin Institute - The Rogosin Kidney Center | New York | New York |
| United States | VA New York Harbor Healthcare System | New York | New York |
| United States | Rutgers New Jersey Medical School | Newark | New Jersey |
| United States | TKS Research, P.L.L.C. | Norfolk | Virginia |
| United States | York Clinical Research, LLC | Norfolk | Virginia |
| United States | UCI Center for Clinical Research | Orange | California |
| United States | Elixia Central | Orlando | Florida |
| United States | Omega Research Orlando, LLC | Orlando | Florida |
| United States | Premier Clinical Research | Overland Park | Kansas |
| United States | Essential Concepts Research Solutions | Palos Hills | Illinois |
| United States | Einstein Medical Center (NDKD) | Philadelphia | Pennsylvania |
| United States | Temple University Hospital | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | AKDHC Medical Research Service LLC | Phoenix | Arizona |
| United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
| United States | Richmond VAMC | Richmond | Virginia |
| United States | Virginia Commonwealth University - Division of Nephrology | Richmond | Virginia |
| United States | St. Clair Nephrology Research | Roseville | Michigan |
| United States | Kaiser Permanente, Sacramento | Sacramento | California |
| United States | Center for Advanced Kidney Research | Saint Clair Shores | Michigan |
| United States | Center for Specialized Medicine - SSM Health Saint Louis University Hospital | Saint Louis | Missouri |
| United States | St. Louis Heart and Vascular, P.C. | Saint Louis | Missouri |
| United States | Washington University Saint Louis | Saint Louis | Missouri |
| United States | San Antonio Kidney | San Antonio | Texas |
| United States | San Antonio Kidney | San Antonio | Texas |
| United States | University of Texas Health San Antonio | San Antonio | Texas |
| United States | UCSF School of Medicine | San Francisco | California |
| United States | Mid Florida Kidney and Hypertension Care, PL | Sanford | Florida |
| United States | Javara Inc./Privia Medical Group Georgia, LLC | Savannah | Georgia |
| United States | University of Washington Medical Center | Seattle | Washington |
| United States | Kidney Specialists of N Houston, PLLC | Shenandoah | Texas |
| United States | Northwest Louisiana Nephrology, LLC - Shreveport | Shreveport | Louisiana |
| United States | Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD | Silver Spring | Maryland |
| United States | Carolina Nephrology, PA | Spartanburg | South Carolina |
| United States | Renal and Transplant Associates of New England, PC | Springfield | Massachusetts |
| United States | Elixia Tampa, LLC | Tampa | Florida |
| United States | Genesis Clinical Research | Tampa | Florida |
| United States | Renal Physicians of Montgomery County, PA | The Woodlands | Texas |
| United States | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California |
| United States | Nephrology and Hypertension Associates, LTD | Tupelo | Mississippi |
| United States | Inova Clinical Trials and Research Center | Tyrone | Georgia |
| United States | Kidney and Hypertension Center | Victorville | California |
| United States | Nephrology Associates of Tidewater, LTD | Virginia Beach | Virginia |
| United States | Children's National Hospital | Washington | District of Columbia |
| United States | The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension | Washington | District of Columbia |
| United States | Milwaukee Nephrologists, SC | Wauwatosa | Wisconsin |
| United States | Tranquil Clinical Research | Webster | Texas |
| United States | Kidney Care and Transplant Services of New England | West Springfield | Massachusetts |
| United States | Eastern Nephrology Associates - Wilmington Office | Wilmington | North Carolina |
| United States | Brookview Hills Research Associates | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Vertex Pharmaceuticals Incorporated |
United States, Belgium, Brazil, Canada, Colombia, France, Ghana, Netherlands, Portugal, Puerto Rico, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis) | From Baseline at Week 48 | ||
| Primary | Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis | From Baseline Through >= Week 48 | ||
| Primary | eGFR Slope Assessed at Study Completion | From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) | ||
| Secondary | Time to Composite Clinical Outcome of a Sustained Decline of >=30 Percent (%) in eGFR, the Onset of end-stage Kidney Disease or Death | From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) | ||
| Secondary | Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) | Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls) | ||
| Secondary | Maximum Plasma Concentration (Cmax) of VX-147 | Day 1 and Week 40 | ||
| Secondary | Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147 | Day 1 and Week 40 | ||
| Secondary | Observed Pre-dose Plasma Concentration (Ctrough) of VX-147 | Day 1 up to Week 40 | ||
| Secondary | Acceptability Tablet Formulation of VX-147 in Pediatric Participants using the Convenience Domain of the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 | Day 1 and Week 48 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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|
Phase 4 |