VX-147 在 APOL1 介导的蛋白尿性肾病成人中的 2/3 期适应性研究 (AMPLITUDE)
一项 2/3 期适应性、双盲、安慰剂对照研究,以评估 VX-147 在 18 岁及以上患有 APOL1 介导的蛋白尿性肾病的受试者中的疗效和安全性
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.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
-
-
-
Montreal、加拿大
- Recherche GCP Research
-
Toronto、加拿大
- Women's College Hospital
-
-
-
-
-
Accra、加纳
- University of Ghana Medical School - Nephrology
-
Cantonments、加纳
- The Bank Hospital
-
Kumasi、加纳
- Komfo Anokye Teaching Hospital - Nephrology
-
-
-
-
-
Atlántico、哥伦比亚
- Clinica de La Costa S.A.S
-
Bogotá、哥伦比亚
- Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO
-
Cali、哥伦比亚
- Fundación Valle Del Lili
-
Cartagena、哥伦比亚
- Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS
-
Ibague、哥伦比亚
- Mediservis del Tolima IPS S.A.S.
-
Medellín、哥伦比亚
- Fundación Hospitalaria San Vicente de Paul
-
Medellín、哥伦比亚
- Promotora Medica Las Americas S.A. - Clinica Las Americas
-
-
-
-
-
Enugu、尼日利亚
- University of Nigeria Teaching Hospital
-
Ibadan、尼日利亚
- University College Hospital
-
Idi-Araba、尼日利亚
- Lagos University Teaching Hospital
-
Ikeja、尼日利亚
- Lagos State University Teaching Hospital
-
Lagos、尼日利亚
- Nigerian Institute of Medical Research
-
-
-
-
-
Aracaju、巴西
- Centro de Pesquisa Clinica do Coracao
-
Belo Horizonte、巴西
- Santa Casa de Misericórdia de Belo Horizonte
-
Botucatu、巴西
- Faculdade de Medicina de Botucatu - CKD and Hypertension Department
-
Botucatu、巴西
- Faculdade de Medicina de Botucatu - Kidney Transplantation Department
-
Campinas、巴西
- IPECC - Instituto de Pesquisa Clinica de Campinas
-
Curitiba、巴西
- Instituto Pro-Renal
-
Curitiba、巴西
- PUC Trials - Unidade Epicenter
-
Fortaleza、巴西
- Instituto de Ensino e Pesquisa Clinica do Ceara
-
Fortaleza、巴西
- Walter Cantídio University Hospital
-
Goiânia、巴西
- Federal University of Goiás (UFG)
-
Juiz de Fora、巴西
- Cmip-Centro Mineiro de Pesquisa Ltda
-
Juiz de Fora、巴西
- Galileo Medical Research Ltda
-
Marília、巴西
- ICM - Instituto do Coracao de Marilia
-
Monte Alegre、巴西
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
-
Porto Alegre、巴西
- Dom Vicente Scherer Hospital
-
Porto Alegre、巴西
- Hospital de Clínicas de Porto Alegre - Nephrology
-
Recife、巴西
- Centro de Pesquisa Clinica Professor Salomao Kelner
-
Rio de Janeiro、巴西
- Hospital São Lucas
-
Rio de Janeiro、巴西
- Hospital Universitario Pedro Ernesto - Departamento de Nefrologia
-
Rio de Janeiro、巴西
- Hospital Universitario Pedro Ernesto - Departamento de Patologia
-
Salvador、巴西
- Comlexo Hospitalar Universitário Professor Edgard Santos
-
Salvador、巴西
- CSB Group of Nephrology Brazil
-
Salvador、巴西
- Hospital Ana Nery/SESAB
-
Santo André、巴西
- Praxis Pesquisa Medica
-
São José do Rio Preto、巴西
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
-
São Paulo、巴西
- Irmandade Da Santa Casa De Misericordia De Sao Paulo
-
São Paulo、巴西
- Hospital do Rim - Fundação Oswaldo Ramos
-
São Paulo、巴西
- Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular
-
São Paulo、巴西
- Hospital Nove de Julho - Nephrology
-
-
-
-
-
Brussels、比利时
- Universite Catholique de Louvain - Nephrology
-
Leuven、比利时
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology
-
-
-
-
-
Créteil、法国
- Hopital Henri Mondor - Nephrology
-
Grenoble、法国
- Hospital Nord Michallon - Nephrology
-
Le Kremlin-Bicêtre、法国
- Bicetre Hospital
-
Limoges、法国
- CHU Dupuytren 2 - Néphrologie, dialyse, transplantations
-
Marseille、法国
- Hôpital de la Conception
-
Paris、法国
- Université Paris-Descartes / Hôpital Européen Georges Pompidou
-
Paris、法国
- Ambroise Paré Hospital
-
Paris、法国
- Hopital Necker Enfants Malades - Nephrology
-
Paris、法国
- Hopital Tenon
-
Pointe à Pitre、法国
- CHU de Guadeloupe
-
Saint-Ouen、法国
- AURA Nord
-
Toulouse、法国
- Hopital de Rangueil
-
-
-
-
-
Mayagüez、波多黎各、06680
- FDI Clinical Research
-
Rio Piedras、波多黎各、00935
- University of Puerto Rico
-
San Juan、波多黎各、00917
- GCM Medical Group, PSC
-
-
-
-
Alabama
-
Alabaster、Alabama、美国、35007
- Alabama Kidney Research
-
Birmingham、Alabama、美国、35233
- Children's Hospital of Alabama
-
Birmingham、Alabama、美国、35211
- Cardiology, P.C.
-
Birmingham、Alabama、美国、35210
- EmVenio Research - Mobile Unit - Birmingham
-
Birmingham、Alabama、美国、35294
- The Kirklin Clinic - Nephrology
-
Fairhope、Alabama、美国、36532
- Nephrology Associates
-
Huntsville、Alabama、美国、35805
- Nephrology Consultants, LLC
-
Huntsville、Alabama、美国、35801
- Heart Center Research LLC
-
Montgomery、Alabama、美国、36117
- Renal Associates of Alabama, LLC
-
-
Arizona
-
Phoenix、Arizona、美国、85016
- Arizona Kidney Disease and Hypertension Center - Thomas Office
-
Phoenix、Arizona、美国、85016
- Phoenix Children's Hospital, Inc. - Nephrology
-
-
Arkansas
-
Little Rock、Arkansas、美国、72204
- CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock
-
Little Rock、Arkansas、美国、72205
- UAMS Medical Center - Pulmonology
-
-
California
-
Fresno、California、美国、93720
- The Medical Research Group - Saint Agnes Medical Center
-
Granada Hills、California、美国、91344
- Amicis Research Center - Balboa
-
Granada Hills、California、美国、91344
- Kidney Care Center of North Valley
-
Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
-
Los Angeles、California、美国、90027
- Kaiser Permanente Los Angeles Medical Center
-
Los Angeles、California、美国、90022
- Eastside Clinical Research Associates
-
Los Angeles、California、美国、90095
- UCLA Division of Nephrology
-
Orange、California、美国、92868
- UCI Center for Clinical Research
-
Sacramento、California、美国、95825
- Kaiser Permanente Sacramento Medical Center
-
San Francisco、California、美国、94143
- Helen Diller Medical Center at Parnassus Heights
-
Torrance、California、美国、90502
- UCLA Lundquist Institute at Harbor-UCLA Medical Center
-
Victorville、California、美国、92395
- Kidney and Hypertension Center
-
-
Connecticut
-
Bloomfield、Connecticut、美国、06002
- Greater Hartford Nephrology
-
Middlebury、Connecticut、美国、06762
- Nephrology & Hypertension Associates, PC
-
New Haven、Connecticut、美国、06510
- Yale University - Yale Nephrology Clinical Research Clinic
-
-
District of Columbia
-
Washington D.C.、District of Columbia、美国、20010
- Children's National Hospital - Nephrology
-
Washington D.C.、District of Columbia、美国、20037
- The George Washington University - GW Medical Faculty Associates
-
Washington D.C.、District of Columbia、美国、20422
- Veterans Affairs Medical Center - Washington D.C
-
-
Florida
-
Bay Pines、Florida、美国、33744
- Bay Pines Foundation
-
Bradenton、Florida、美国、34209
- Nova Clinical Research, LLC - Bradenton - 59th St
-
Brandon、Florida、美国、33511
- Clinical Research of Brandon, LLC
-
Coral Gables、Florida、美国、33134
- Horizon Research Group - Coral Gables
-
Coral Gables、Florida、美国、33134
- AMR-Miami
-
Coral Springs、Florida、美国、33071
- South Florida Nephrology Research
-
Delray Beach、Florida、美国、33445
- Delray Physician Care Center
-
Gainesville、Florida、美国、32608
- North Florida/South Georgia Veterans Health System
-
Gainesville、Florida、美国、32610
- Shands Hospital - Nephrology
-
Hallandale、Florida、美国、33009
- Velocity Clinical Research - Hallandale Beach
-
Hialeah、Florida、美国、33010
- Qway Research
-
Hollywood、Florida、美国、33024
- Elixia Pines
-
Jacksonville、Florida、美国、32209
- UF Health Cardiovascular Center - Jacksonville
-
Lauderdale Lakes、Florida、美国、33313
- South Florida Research Institute
-
Miami、Florida、美国、33126
- Total Research Group, LLC
-
Miami、Florida、美国、33182
- Cordova Research Institute
-
Miami Springs、Florida、美国、33166
- South Florida Research
-
Orlando、Florida、美国、32806
- CTR Oakwater, LLC
-
Orlando、Florida、美国、32806
- Synexus Clinical Research - Orlando
-
Orlando、Florida、美国、32808
- Omega Research Orlando, LLC - Mercy Dr
-
Sanford、Florida、美国、32771
- Infigo Clinical Research
-
Tampa、Florida、美国、33603
- Genesis Clinical Research
-
Tampa、Florida、美国、33618
- Elixia Tampa
-
-
Georgia
-
Acworth、Georgia、美国、30101
- American Clinical Trials LLC - Acworth
-
Atlanta、Georgia、美国、30310
- Morehouse School of Medicine, Grady Memorial Hospital
-
Atlanta、Georgia、美国、30305
- Kaiser Permanente Georgia
-
Atlanta、Georgia、美国、30342
- Fides Clinical Research
-
Atlanta、Georgia、美国、30309
- Advanced Clinical Research of Atlanta
-
Atlanta、Georgia、美国、30308
- Emory School of Medicine - Renal Division
-
Atlanta、Georgia、美国、30322
- Emory Childrens Center - Nephrology
-
Atlanta、Georgia、美国、30328
- Synexus Clinical Research - Atlanta (DRS)
-
Augusta、Georgia、美国、30912
- Augusta University Medical College of Georgia - Adult Sickle Cell Clinic
-
Brunswick、Georgia、美国、31520
- Coastal Medical Research
-
College Park、Georgia、美国、30337
- Randomize Now - College Park
-
Columbus、Georgia、美国、31904
- Renal Associates
-
Columbus、Georgia、美国、31904
- Clincept - Veterans Pkwy.
-
Decatur、Georgia、美国、30033
- Atlanta VA Healthcare System
-
Decatur、Georgia、美国、30030
- Georgia Nephrology - Decatur
-
Douglasville、Georgia、美国、30134
- American Clinical Trials LLC - Douglasville
-
East Point、Georgia、美国、30344
- Southeast Kidney Associates
-
Fayetteville、Georgia、美国、30214
- Javara Inc./Privia Medical Group - Fayetteville, GA
-
Lawrenceville、Georgia、美国、30046
- Georgia Nephrology - Lawrenceville - Billing Office
-
Savannah、Georgia、美国、31406
- Javara Inc./Privia Medical Group - Savannah, GA
-
Tyrone、Georgia、美国、30290
- Inova Clinical Trials and Research Center
-
Union City、Georgia、美国、30291
- Rophe Adult and Pediatric Medicine
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern Medical Group
-
Chicago、Illinois、美国、60602
- Synexus Clinical Research - Chicago (DRS)
-
Chicago、Illinois、美国、60608
- EmVenio Research - Chicago
-
Chicago、Illinois、美国、60611-2605
- Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology
-
Chicago、Illinois、美国、60637
- UChicago Medicine - Comer Children's Hospital
-
Evergreen Park、Illinois、美国、60805
- NANI Research LLC - Evergreen Park IL
-
Hines、Illinois、美国、60141
- Edward Hines Jr VA Hospital
-
Palos Hills、Illinois、美国、60465
- Essential Concepts Research Solutions
-
-
Indiana
-
Fort Wayne、Indiana、美国、46804
- NANI Research LLC - Fort Wayne IN
-
Indianapolis、Indiana、美国、46202
- IU School of Medicine - Nephrology
-
Mishawaka、Indiana、美国、46545
- Nephrology Physicians, LLC
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- University of Iowa Health Care Medical Center- Nephrology
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- Clinical & Translational Science Unit (CTSU) - Nephrology
-
Overland Park、Kansas、美国、66210
- Premier Clinical Research
-
-
Louisiana
-
Baton Rouge、Louisiana、美国、70808
- Renal Associates of Baton Rouge
-
Metairie、Louisiana、美国、70006
- LCMC Health
-
Natchitoches、Louisiana、美国、71457
- Barnum Medical Research - Bienville St
-
New Orleans、Louisiana、美国、70121
- Ochsner Medical Center - New Orleans
-
New Orleans、Louisiana、美国、70112
- Louisiana Clinical and Translational Science (LA CaTS) Center
-
New Orleans、Louisiana、美国、70112
- University Medical Center - New Orleans - Nephrology
-
Shreveport、Louisiana、美国、71103
- Louisiana State University Health Shreveport
-
Shreveport、Louisiana、美国、71101
- Northwest Louisiana Nephrology, LLC
-
West Monroe、Louisiana、美国、71291
- Monroe Research, LLC
-
-
Maryland
-
Annapolis、Maryland、美国、21401
- Javara Inc./Privia Medical Group - Annapolis, MD
-
Baltimore、Maryland、美国、21201
- University of Maryland Medical Center - General Clinical Research Center
-
Baltimore、Maryland、美国、21287
- The Johns Hopkins University - Johns Hopkins Hospital - Nephrology
-
Gaithersburg、Maryland、美国、20879
- Mid-Atlantic Permanente Research Institute
-
Lutherville、Maryland、美国、21093
- Patient First Clinical Trials
-
Oxon Hill、Maryland、美国、20745
- MD Medical Research
-
Silver Spring、Maryland、美国、20901
- Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike
-
-
Massachusetts
-
Boston、Massachusetts、美国、02111
- Tufts Medical Center
-
Boston、Massachusetts、美国、02118
- Boston Medical Center
-
Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Medical Center - Nephrology
-
Roxbury、Massachusetts、美国、02120
- Whittier Street Health Center
-
Springfield、Massachusetts、美国、01107
- Renal and Transplant Associates of New England, PC
-
West Springfield、Massachusetts、美国、01089
- Kidney Care and Transplant Services of New England - West Springfield
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
-
Detroit、Michigan、美国、48202
- Henry Ford Health System - Nephrology
-
Farmington Hills、Michigan、美国、48334
- Quest Research Institute
-
Flint、Michigan、美国、48504
- AA Medical Research Center
-
Lansing、Michigan、美国、48912
- Sparrow Clinical Research Institute
-
Roseville、Michigan、美国、48066
- St. Clair Nephrology Research
-
Saint Clair Shores、Michigan、美国、48081
- Center for Advanced Kidney Research
-
-
Minnesota
-
Edina、Minnesota、美国、55435
- InterMed Consultants - Edina Clinic
-
Minneapolis、Minnesota、美国、55417
- Minneapolis VA Healthcare System
-
-
Mississippi
-
Columbus、Mississippi、美国、39705
- Nephrology Associates, P.C. - Columbus
-
Fayette、Mississippi、美国、39069
- Prime Health and Wellness
-
Grenada、Mississippi、美国、38901
- UMMC Grenada Hospital
-
Jackson、Mississippi、美国、39216
- G.V. (Sonny) Montgomery VAMC
-
Olive Branch、Mississippi、美国、38654
- Olive Branch Family Medical Center
-
Ridgeland、Mississippi、美国、39157
- SKY Integrative Medical Center
-
Tupelo、Mississippi、美国、38801
- Nephrology and Hypertension Associates - Tupelo
-
-
Missouri
-
St Louis、Missouri、美国、63104
- Center for Specialized Medicine - Nephrology
-
St Louis、Missouri、美国、63108
- Barnes-Jewish Center for Outpatient Health
-
St Louis、Missouri、美国、63110
- St. Louis Children's Hospital - Nephrology
-
St Louis、Missouri、美国、63136
- St. Louis Heart and Vascular, P.C.
-
-
Nevada
-
Las Vegas、Nevada、美国、89107
- DaVita Kidney Care - Las Vegas
-
-
New Jersey
-
Camden、New Jersey、美国、08103
- CUH - Sheridan Pavilion - Three Cooper Plaza
-
Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
-
Hamilton、New Jersey、美国、08690
- Bioluminux Clinical Research New Jersey
-
Neptune City、New Jersey、美国、07753
- Jersey Shore University Medical Center
-
Newark、New Jersey、美国、07103
- Rutgers Doctors Office Center
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87108
- New Mexico VA Healthcare System
-
Albuquerque、New Mexico、美国、87109
- Renal Medicine Associates
-
-
New York
-
Brooklyn、New York、美国、11203
- Kings County Hospital
-
Brooklyn、New York、美国、11203
- SUNY Downstate Health Sciences University
-
Brooklyn、New York、美国、11221
- Clindove Research LLC
-
Flushing、New York、美国、11365
- New York Presbyterian Queens
-
Great Neck、New York、美国、11021
- Zucker School of Medicine
-
Laurelton、New York、美国、11413
- Scott Research, Inc.
-
New York、New York、美国、10010
- VA New York Harbor Healthcare System
-
New York、New York、美国、10016
- Grossman School of Medicine
-
New York、New York、美国、10017
- Synexus Clinical Research - New York (DRS)
-
New York、New York、美国、10037
- NYC Health + Hospital/Harlem
-
New York、New York、美国、10021
- The Rogosin Kidney Center
-
New York、New York、美国、10032
- General Nephrology Clinic - New York City
-
New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai - Nephrology
-
The Bronx、New York、美国、10468
- James J. Peters VA Medical Center
-
The Bronx、New York、美国、10461
- Kidney Medical Associates, PLLC
-
The Bronx、New York、美国、10461
- Montefiore Einstein - Albert Einstein College of Medicine
-
The Bronx、New York、美国、10467
- Montefiore Einstein Hospital - Moses Campus
-
-
North Carolina
-
Cary、North Carolina、美国、27511
- North Carolina Nephrology P.A. - Cary
-
Chapel Hill、North Carolina、美国、27599-7155
- UNC Clinical and Translational Research Center
-
Charlotte、North Carolina、美国、28208
- Metrolina Nephrology Associates - Freedom Dr
-
Durham、North Carolina、美国、27710
- Duke University Hospital - Children's Health Center
-
Greenville、North Carolina、美国、27834
- Eastern Nephrology Associates - Greenville Office
-
Jacksonville、North Carolina、美国、28546
- Eastern Nephrology Associates - Jacksonville Office
-
Kinston、North Carolina、美国、28504
- Eastern Nephrology Associates - Kinston Office
-
New Bern、North Carolina、美国、28562
- Eastern Nephrology Associates - New Bern Office
-
Wilmington、North Carolina、美国、28401
- Eastern Nephrology Associates - Wilmington Office
-
Winston-Salem、North Carolina、美国、27103
- Brookview Hills Research Associates
-
-
Ohio
-
Cincinnati、Ohio、美国、45220
- Cincinnati VA Medical Center
-
Cincinnati、Ohio、美国、45206
- UC - DCI McMillan Research Unit
-
Cleveland、Ohio、美国、44195
- Cleveland Clinic - Main Campus
-
Cleveland、Ohio、美国、44106
- UH Cleveland Medical Center - Nephrology
-
Cleveland、Ohio、美国、44106
- Louis Stokes Cleveland VA medical Center
-
Columbus、Ohio、美国、43201
- Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19140
- Lewis Katz School of Medicine at Temple University - Section of Nephrology
-
Philadelphia、Pennsylvania、美国、19107
- Jefferson Health - 33 South 9th Street
-
Philadelphia、Pennsylvania、美国、19141
- Jefferson Einstein Philadelphia Hospital - Nephrology
-
Pittsburgh、Pennsylvania、美国、15224
- Children's Hospital of Pittsburgh - Nephrology
-
-
Rhode Island
-
East Providence、Rhode Island、美国、02915
- Lifespan Clinical Research Center
-
-
South Carolina
-
Charleston、South Carolina、美国、29425
- Medical University of South Carolina - Pulmonology
-
Charleston、South Carolina、美国、29412
- Pharmacorp Clinical Trials, Inc
-
Columbia、South Carolina、美国、29203
- Columbia Nephrology Associates, PA
-
Spartanburg、South Carolina、美国、29306
- Carolina Nephrology, PA
-
-
Tennessee
-
Chattanooga、Tennessee、美国、37404
- Southeast Renal Research Institute
-
Memphis、Tennessee、美国、38119
- CNS Healthcare - Memphis
-
Memphis、Tennessee、美国、38105
- Le Bonheur Children's Hospital - Outpatient Clinic
-
Nashville、Tennessee、美国、37212
- Nashville VA Medical Center
-
Nashville、Tennessee、美国、37232
- Nephrology Clinical Trials Center
-
Nashville、Tennessee、美国、37208
- Nashville General Hospital - Meharry Medical College - Nephrology
-
-
Texas
-
Arlington、Texas、美国、76015
- Arlington Nephrology
-
Arlington、Texas、美国、76002
- Dallas Renal Group - Mansfield
-
Dallas、Texas、美国、75230
- Zenos Clinical Research
-
Dallas、Texas、美国、75231
- Nephrotex Research Group
-
Dallas、Texas、美国、75246
- Dallas Nephrology Associates - Dallas Landry Office
-
Dallas、Texas、美国、75390
- UTSW Medical Center - Nephrology
-
Dallas、Texas、美国、75204
- Baylor Scott and White Research Institute - Nephrology
-
Dallas、Texas、美国、75230
- Dallas Renal Group- Dallas
-
Dallas、Texas、美国、75237
- Dallas Renal Group - Liberty Dallas Dialysis Center
-
Dallas、Texas、美国、75325
- Southwest Family Medicine Associates (SFMA) - Dallas
-
El Paso、Texas、美国、79925
- Davita Clinical Research - El Paso
-
Fort Worth、Texas、美国、76104
- Cook Children's Medical Center
-
Houston、Texas、美国、77054
- Prolato Clinical Research Center - Kirby Dr
-
Houston、Texas、美国、77054
- Ronald Ralph MD PA
-
Houston、Texas、美国、77074
- Houston Medical Research Institute, LLC
-
Houston、Texas、美国、77090
- Clinical Research Strategies - Romano North Main Office
-
Houston、Texas、美国、77099
- Frenova-Southwest Houston
-
Lewisville、Texas、美国、75057
- NTKDA Lewisville
-
Lewisville、Texas、美国、75067
- Prime Clinical Research Inc - Lewisville
-
Lubbock、Texas、美国、79430
- Texas Tech University Health Sciences Center
-
Mansfield、Texas、美国、76063
- Prime Clinical Research - Mansfield - Regency Parkway
-
San Antonio、Texas、美国、78229
- University of Texas Health Science Center - Nephrology
-
San Antonio、Texas、美国、78251
- San Antonio Kidney Disease Center Physicians Group - Westover Hills
-
Shenandoah、Texas、美国、77384
- Kidney Specialists of N Houston, PLLC
-
The Woodlands、Texas、美国、77384
- Renal Research of Montgomery County, PLLC
-
Webster、Texas、美国、77598
- Tranquil Clinical Research
-
-
Virginia
-
Charlottesville、Virginia、美国、22908
- UVA Health - Nephrology Clinical Research Center
-
Norfolk、Virginia、美国、23504
- Tidewater Kidney Specialists - Church St.
-
Norfolk、Virginia、美国、23504
- York Clinical Research, LLC
-
Richmond、Virginia、美国、23249
- McGuire Research Institute, Inc. (151)
-
Richmond、Virginia、美国、23298
- Virginia Commonwealth University - Division of Nephrology
-
Virginia Beach、Virginia、美国、23454
- Nephrology Associates of Tidewater, LTD
-
-
Washington
-
Seattle、Washington、美国、98195
- UW Medical Center - Montlake - Nephrology
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin - Pulmonology
-
Wauwatosa、Wisconsin、美国、53226
- Milwaukee Nephrologists - Wauwatosa
-
-
-
-
-
Basildon、英国
- Mid and South Essex Hospitals NHS Trust
-
Bellshill、英国
- Synexus Clinical Research - Glasgow (DRS)
-
Birmingham、英国
- Queen Elizabeth Hospital Birmingham
-
Birmingham、英国
- FutureMeds Birmingham
-
Birmingham、英国
- Synexus Clinical Research - Midlands (DRS)
-
Carshalton、英国
- Epsom and St Helier University Hospitals NHS Trust
-
Leicester、英国
- Leicester General Hospital
-
London、英国
- Great Ormond Street Hospital for Children
-
London、英国
- St Pancras Clinical Research
-
London、英国
- King's College Hospital - Pulmonology
-
London、英国
- Royal Free Hospital - Nephrology
-
London、英国
- St George's Hospital London - Nephrology
-
London、英国
- Guy's Hospital - Endocrinology
-
London、英国
- The Royal London Hospital - Nephrology
-
Manchester、英国
- Manchester Royal Infirmary - Endocrinology
-
Manchester、英国
- Synexus Clinical Research - NW Consortium Manchester (DRS)
-
Manchester、英国
- Wythenshawe Hospital - Medicines Evaluation Unit
-
Nottingham、英国
- Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology
-
-
-
-
-
Amsterdam、荷兰
- Amsterdam UMC - Amsterdam Public Health Research Institute
-
-
-
-
-
Amadora、葡萄牙
- Unidade Local de Saude Amadora/Sintra, E.P.E.
-
Lisbon、葡萄牙
- Hospital Curry Cabral - Serviço de Nefrologia
-
Lisbon、葡萄牙
- Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology
-
Loures、葡萄牙
- Unidade Local de Saúde de Loures-Odivelas, E.P.E.
-
-
-
-
-
Barcelona、西班牙
- Hospital Clinic de Barcelona - Nephrology
-
Barcelona、西班牙
- Hospital Universitari Vall d´Hebron - Servicio de Pediatria
-
Córdoba、西班牙
- Reina Sofia University Hospital - Nephrology
-
Madrid、西班牙
- Hospital Universitario 12 de Octubre - Nephrology
-
Seville、西班牙
- Hospital Universitario Virgen Macarena
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:顺序分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Part A (Phase 2/3): VX-147
Participants will be randomized to receive different doses of VX-147. Participants will receive the selected dose of VX-147 for atleast 96 weeks. |
Tablets for oral administration. |
|
安慰剂比较:Part A (Phase 2/3): Placebo
Participants will receive placebo matched to VX-147. |
Tablets for oral administration. |
|
实验性的:Part B (Phase 3): VX-147
Participants who complete Part A will receive VX-147 for an additional 96 weeks. |
Tablets for oral administration. |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
第A部分:第48周时尿蛋白与肌酐比值(UPCR)相对于基线的百分比变化(基于第48周中期分析评估)
大体时间:从基线至第48周
|
从基线至第48周
|
|
A部分:中期分析中评估的估算肾小球滤过率(eGFR)斜率
大体时间:从基线至第48周及以上
|
从基线至第48周及以上
|
|
A部分:最终分析时评估的eGFR斜率
大体时间:从基线期至研究完成(最终分析时评估至少2年的eGFR数据)
|
从基线期至研究完成(最终分析时评估至少2年的eGFR数据)
|
|
B部分:根据发生不良事件(AEs)和严重不良事件(SAEs)的参与者数量评估的安全性和耐受性
大体时间:第1天至研究完成(最后一名受试者入组后约4年)
|
第1天至研究完成(最后一名受试者入组后约4年)
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
A部分:通过发生不良事件(AEs)和严重不良事件(SAEs)的参与者人数评估的安全性和耐受性
大体时间:从第1天至研究完成(最后一名参与者入组后约2年)
|
从第1天至研究完成(最后一名参与者入组后约2年)
|
|
Part A: VX-147 的最大血浆浓度 (Cmax)
大体时间:第1天和第40周
|
第1天和第40周
|
|
Part A:VX-147给药间隔期内浓度-时间曲线下面积(AUCtau)
大体时间:第1天和第40周
|
第1天和第40周
|
|
A部分:VX-147 给药前血浆浓度(Ctrough)观测值
大体时间:第1天至第40周
|
第1天至第40周
|
|
A部分:使用药物满意度问卷(TSQM)1.4版便利性领域评估儿科参与者对VX-147片剂配方的可接受性
大体时间:第 1 天和第 48 周
|
第 1 天和第 48 周
|
|
B部分:UPCR随时间相对于基线的百分比变化
大体时间:从基线至研究完成(约最后一名受试者入组后4年)
|
从基线至研究完成(约最后一名受试者入组后4年)
|
|
Part B:eGFR斜率评估
大体时间:第1天至研究完成(最后一名参与者入组后约4年)
|
第1天至研究完成(最后一名参与者入组后约4年)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- VX21-147-301
- 2024-515633-15-00 (其他标识符:EU Trial (CTIS) Number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.