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Fase 2/3 adaptiv undersøgelse af VX-147 hos voksne med APOL1-medieret proteinurisk nyresygdom (AMPLITUDE)

1. juni 2026 opdateret af: Vertex Pharmaceuticals Incorporated

En fase 2/3 adaptiv, dobbeltblind, placebokontrolleret undersøgelse for at evaluere effektiviteten og sikkerheden af ​​VX-147 hos forsøgspersoner i alderen 18 år og ældre med APOL1-medieret proteinurisk nyresygdom

Formålet med denne undersøgelse er at evaluere effektivitet, sikkerhed, tolerabilitet og farmakokinetik (PK) af VX-147 hos deltagere i alderen 18 år og ældre med apolipoprotein L1 (APOL1)-medieret proteinurisk nyresygdom.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

466

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Belgien
      • Leuven, Belgien
        • Rekruttering
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology
    • Brussels Capital
      • Woluwe-Saint-Lambert, Brussels Capital, Belgien
        • Rekruttering
        • Universite Catholique de Louvain - Pulmonology
  • Brasilien
      • Aracaju, Brasilien
        • Rekruttering
        • Centro de Pesquisa Clínica do Coração
      • Belo Horizonte, Brasilien
        • Rekruttering
        • Santa Casa de Misericórdia de Belo Horizonte
      • Botucatu, Brasilien
        • Rekruttering
        • Faculdade de Medicina de Botucatu - CKD and Hypertension Department
      • Botucatu, Brasilien
        • Rekruttering
        • Faculdade de Medicina de Botucatu - Kidney Transplantation Department
      • Campinas, Brasilien
        • Rekruttering
        • IPECC - Instituto de Pesquisa Clínica de Campinas
      • Curitiba, Brasilien
        • Rekruttering
        • Instituto Pro-Renal
      • Curitiba, Brasilien
        • Afsluttet
        • PUC Trials - Unidade Epicenter
      • Fortaleza, Brasilien
        • Rekruttering
        • Walter Cantídio University Hospital
      • Fortaleza, Brasilien
        • Rekruttering
        • Instituto de Ensino e Pesquisa Clinica do Ceara
      • Goiânia, Brasilien
        • Rekruttering
        • Federal University of Goiás (UFG)
      • Juiz de Fora, Brasilien
        • Rekruttering
        • Cmip-Centro Mineiro de Pesquisa Ltda
      • Juiz de Fora, Brasilien
        • Afsluttet
        • Galileo Medical Research Ltda
      • Marília, Brasilien
        • Rekruttering
        • ICM - Instituto do Coracao de Marilia
      • Monte Alegre, Brasilien
        • Rekruttering
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
      • Porto Alegre, Brasilien
        • Afsluttet
        • Dom Vicente Scherer Hospital
      • Porto Alegre, Brasilien
        • Afsluttet
        • Hospital de Clínicas de Porto Alegre - Nephrology
      • Recife, Brasilien
        • Rekruttering
        • Centro de Pesquisa Clinica Professor Salomao Kelner
      • Rio de Janeiro, Brasilien
        • Afsluttet
        • Hospital sao lucas
      • Rio de Janeiro, Brasilien
        • Rekruttering
        • Hospital Universitario Pedro Ernesto - Departamento de Nefrologia
      • Rio de Janeiro, Brasilien
        • Rekruttering
        • Hospital Universitario Pedro Ernesto - Departamento de Patologia
      • Salvador, Brasilien
        • Rekruttering
        • CSB Group of Nephrology Brazil
      • Salvador, Brasilien
        • Rekruttering
        • Hospital Ana Nery/SESAB
      • Salvador, Brasilien
        • Rekruttering
        • Comlexo Hospitalar Universitário Professor Edgard Santos
      • Santo André, Brasilien
        • Rekruttering
        • Praxis Pesquisa Medica
      • São José do Rio Preto, Brasilien
        • Afsluttet
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
      • São Paulo, Brasilien
        • Rekruttering
        • Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular
      • São Paulo, Brasilien
        • Rekruttering
        • Hospital do Rim - Fundação Oswaldo Ramos
      • São Paulo, Brasilien
        • Rekruttering
        • Hospital Nove de Julho - Nephrology
      • São Paulo, Brasilien
        • Rekruttering
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo
  • Canada
      • Montreal, Canada
        • Afsluttet
        • Recherche GCP Research
      • Toronto, Canada
        • Rekruttering
        • Women's College Hospital
  • Colombia
      • Atlántico, Colombia
        • Rekruttering
        • Clínica de la Costa S.A.S
      • Bogotá, Colombia
        • Rekruttering
        • Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO
      • Cali, Colombia
        • Rekruttering
        • Fundacion Valle Del Lili
      • Cartagena, Colombia
        • Rekruttering
        • Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS
      • Ibague, Colombia
        • Rekruttering
        • Mediservis del Tolima IPS S.A.S.
      • Medellín, Colombia
        • Rekruttering
        • Fundación Hospitalaria San Vicente de Paul
      • Medellín, Colombia
        • Rekruttering
        • Promotora Medica Las Americas S.A. - Clinica Las Americas
  • Det Forenede Kongerige
      • Basildon, Det Forenede Kongerige
        • Rekruttering
        • Mid and South Essex Hospitals NHS Trust
      • Bellshill, Det Forenede Kongerige
        • Rekruttering
        • Synexus Clinical Research - Glasgow (DRS)
      • Birmingham, Det Forenede Kongerige
        • Rekruttering
        • Queen Elizabeth Hospital Birmingham
      • Birmingham, Det Forenede Kongerige
        • Rekruttering
        • Synexus Clinical Research - Midlands (DRS)
      • Birmingham, Det Forenede Kongerige
        • Afsluttet
        • FutureMeds Birmingham
      • Carshalton, Det Forenede Kongerige
        • Afsluttet
        • Epsom and St Helier University Hospitals NHS Trust
      • Leicester, Det Forenede Kongerige
        • Rekruttering
        • Leicester General Hospital
      • London, Det Forenede Kongerige
        • Rekruttering
        • St Pancras Clinical Research
      • London, Det Forenede Kongerige
        • Afsluttet
        • Great Ormond Street Hospital for Children
      • London, Det Forenede Kongerige
        • Rekruttering
        • Guy's Hospital - Endocrinology
      • London, Det Forenede Kongerige
        • Rekruttering
        • King's College Hospital - Pulmonology
      • London, Det Forenede Kongerige
        • Rekruttering
        • Royal Free Hospital - Nephrology
      • London, Det Forenede Kongerige
        • Rekruttering
        • St George's Hospital London - Nephrology
      • London, Det Forenede Kongerige
        • Rekruttering
        • The Royal London Hospital - Nephrology
      • Manchester, Det Forenede Kongerige
        • Rekruttering
        • Manchester Royal Infirmary - Endocrinology
      • Manchester, Det Forenede Kongerige
        • Rekruttering
        • Synexus Clinical Research - NW Consortium Manchester (DRS)
      • Manchester, Det Forenede Kongerige
        • Rekruttering
        • Wythenshawe Hospital - Medicines Evaluation Unit
      • Nottingham, Det Forenede Kongerige
        • Rekruttering
        • Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology
  • Forenede Stater
    • Alabama
      • Alabaster, Alabama, Forenede Stater, 35007
        • Rekruttering
        • Alabama Kidney Research
      • Birmingham, Alabama, Forenede Stater, 35233
        • Rekruttering
        • Children's Hospital of Alabama
      • Birmingham, Alabama, Forenede Stater, 35210
        • Rekruttering
        • EmVenio Research - Mobile Unit - Birmingham
      • Birmingham, Alabama, Forenede Stater, 35294
        • Rekruttering
        • The Kirklin Clinic - Nephrology
      • Birmingham, Alabama, Forenede Stater, 35211
        • Afsluttet
        • Cardiology, P.C.
      • Fairhope, Alabama, Forenede Stater, 36532
        • Rekruttering
        • Nephrology Associates
      • Huntsville, Alabama, Forenede Stater, 35805
        • Rekruttering
        • Nephrology Consultants, LLC
      • Huntsville, Alabama, Forenede Stater, 35801
        • Rekruttering
        • Heart Center Research Llc
      • Montgomery, Alabama, Forenede Stater, 36117
        • Rekruttering
        • Renal Associates of Alabama, LLC
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85202
        • Trukket tilbage
        • Arizona Kidney Disease and Hypertension Center - Banner Desert Office
      • Phoenix, Arizona, Forenede Stater, 85016
        • Rekruttering
        • Arizona Kidney Disease and Hypertension Center - Thomas Office
      • Phoenix, Arizona, Forenede Stater, 85016
        • Rekruttering
        • Phoenix Children's Hospital, Inc. - Nephrology
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72204
        • Afsluttet
        • CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Afsluttet
        • UAMS Medical Center - Pulmonology
    • California
      • Fresno, California, Forenede Stater, 93720
        • Rekruttering
        • The Medical Research Group - Saint Agnes Medical Center
      • Granada Hills, California, Forenede Stater, 91344
        • Rekruttering
        • Amicis Research Center - Balboa
      • Granada Hills, California, Forenede Stater, 91344
        • Rekruttering
        • Kidney Care Center of North Valley
      • Los Angeles, California, Forenede Stater, 90048
        • Rekruttering
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90027
        • Rekruttering
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, Forenede Stater, 90022
        • Rekruttering
        • Eastside Clinical Research Associates
      • Los Angeles, California, Forenede Stater, 90095
        • Afsluttet
        • UCLA Division of Nephrology
      • Orange, California, Forenede Stater, 92868
        • Rekruttering
        • UCI Center for Clinical Research
      • Sacramento, California, Forenede Stater, 95825
        • Rekruttering
        • Kaiser Permanente Sacramento Medical Center
      • San Francisco, California, Forenede Stater, 94143
        • Rekruttering
        • Helen Diller Medical Center at Parnassus Heights
      • Torrance, California, Forenede Stater, 90502
        • Rekruttering
        • UCLA Lundquist Institute at Harbor-UCLA Medical Center
      • Victorville, California, Forenede Stater, 92395
        • Afsluttet
        • Kidney and Hypertension Center
    • Connecticut
      • Bloomfield, Connecticut, Forenede Stater, 06002
        • Rekruttering
        • Greater Hartford Nephrology
      • Middlebury, Connecticut, Forenede Stater, 06762
        • Rekruttering
        • Nephrology & Hypertension Associates, PC
      • New Haven, Connecticut, Forenede Stater, 06510
        • Rekruttering
        • Yale University - Yale Nephrology Clinical Research Clinic
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20010
        • Rekruttering
        • Children's National Hospital - Nephrology
      • Washington D.C., District of Columbia, Forenede Stater, 20037
        • Rekruttering
        • The George Washington University - GW Medical Faculty Associates
      • Washington D.C., District of Columbia, Forenede Stater, 20422
        • Rekruttering
        • Veterans Affairs Medical Center - Washington D.C
    • Florida
      • Bay Pines, Florida, Forenede Stater, 33744
        • Rekruttering
        • Bay Pines Foundation
      • Bradenton, Florida, Forenede Stater, 34209
        • Rekruttering
        • Nova Clinical Research, LLC - Bradenton - 59th St
      • Brandon, Florida, Forenede Stater, 33511
        • Rekruttering
        • Clinical Research of Brandon, LLC
      • Coral Gables, Florida, Forenede Stater, 33134
        • Afsluttet
        • Horizon Research Group - Coral Gables
      • Coral Gables, Florida, Forenede Stater, 33134
        • Afsluttet
        • AMR-Miami
      • Coral Springs, Florida, Forenede Stater, 33071
        • Rekruttering
        • South Florida Nephrology Research
      • Delray Beach, Florida, Forenede Stater, 33445
        • Rekruttering
        • Delray Physician Care Center
      • Gainesville, Florida, Forenede Stater, 32608
        • Rekruttering
        • North Florida/South Georgia Veterans Health System
      • Gainesville, Florida, Forenede Stater, 32610
        • Rekruttering
        • Shands Hospital - Nephrology
      • Hallandale, Florida, Forenede Stater, 33009
        • Afsluttet
        • Velocity Clinical Research - Hallandale Beach
      • Hialeah, Florida, Forenede Stater, 33010
        • Afsluttet
        • Qway Research
      • Hollywood, Florida, Forenede Stater, 33024
        • Afsluttet
        • Elixia Pines
      • Jacksonville, Florida, Forenede Stater, 32209
        • Rekruttering
        • UF Health Cardiovascular Center - Jacksonville
      • Lauderdale Lakes, Florida, Forenede Stater, 33313
        • Rekruttering
        • South Florida Research Institute
      • Miami, Florida, Forenede Stater, 33126
        • Rekruttering
        • Total Research Group, LLC
      • Miami, Florida, Forenede Stater, 33180
        • Trukket tilbage
        • MedBio Trials
      • Miami, Florida, Forenede Stater, 33182
        • Rekruttering
        • Cordova Research Institute
      • Miami Springs, Florida, Forenede Stater, 33166
        • Rekruttering
        • South Florida Research
      • Orlando, Florida, Forenede Stater, 32806
        • Aktiv, ikke rekrutterende
        • CTR Oakwater, LLC
      • Orlando, Florida, Forenede Stater, 32806
        • Afsluttet
        • Synexus Clinical Research - Orlando
      • Orlando, Florida, Forenede Stater, 32808
        • Rekruttering
        • Omega Research Orlando, LLC - Mercy Dr
      • Sanford, Florida, Forenede Stater, 32771
        • Rekruttering
        • Infigo Clinical Research
      • Tampa, Florida, Forenede Stater, 33603
        • Afsluttet
        • Genesis Clinical Research
      • Tampa, Florida, Forenede Stater, 33618
        • Afsluttet
        • Elixia Tampa
    • Georgia
      • Acworth, Georgia, Forenede Stater, 30101
        • Rekruttering
        • American Clinical Trials LLC - Acworth
      • Atlanta, Georgia, Forenede Stater, 30305
        • Rekruttering
        • Kaiser Permanente Georgia
      • Atlanta, Georgia, Forenede Stater, 30310
        • Rekruttering
        • Morehouse School of Medicine, Grady Memorial Hospital
      • Atlanta, Georgia, Forenede Stater, 30342
        • Rekruttering
        • Fides Clinical Research
      • Atlanta, Georgia, Forenede Stater, 30308
        • Rekruttering
        • Emory School of Medicine - Renal Division
      • Atlanta, Georgia, Forenede Stater, 30322
        • Rekruttering
        • Emory Childrens Center - Nephrology
      • Atlanta, Georgia, Forenede Stater, 30328
        • Rekruttering
        • Synexus Clinical Research - Atlanta (DRS)
      • Atlanta, Georgia, Forenede Stater, 30309
        • Afsluttet
        • Advanced Clinical Research of Atlanta
      • Augusta, Georgia, Forenede Stater, 30912
        • Rekruttering
        • Augusta University Medical College of Georgia - Adult Sickle Cell Clinic
      • Brunswick, Georgia, Forenede Stater, 31520
        • Afsluttet
        • Coastal Medical Research
      • College Park, Georgia, Forenede Stater, 30337
        • Rekruttering
        • Randomize Now - College Park
      • Columbus, Georgia, Forenede Stater, 31904
        • Rekruttering
        • Clincept - Veterans Pkwy.
      • Columbus, Georgia, Forenede Stater, 31904
        • Rekruttering
        • Renal Associates
      • Decatur, Georgia, Forenede Stater, 30030
        • Rekruttering
        • Georgia Nephrology - Decatur
      • Decatur, Georgia, Forenede Stater, 30033
        • Afsluttet
        • Atlanta VA Healthcare System
      • Douglasville, Georgia, Forenede Stater, 30134
        • Rekruttering
        • American Clinical Trials LLC - Douglasville
      • East Point, Georgia, Forenede Stater, 30344
        • Rekruttering
        • Southeast Kidney Associates
      • Fayetteville, Georgia, Forenede Stater, 30214
        • Rekruttering
        • Javara Inc./Privia Medical Group - Fayetteville, GA
      • Lawrenceville, Georgia, Forenede Stater, 30046
        • Rekruttering
        • Georgia Nephrology - Lawrenceville - Billing Office
      • Savannah, Georgia, Forenede Stater, 31406
        • Rekruttering
        • Javara Inc./Privia Medical Group - Savannah, GA
      • Tyrone, Georgia, Forenede Stater, 30290
        • Rekruttering
        • Inova Clinical Trials and Research Center
      • Union City, Georgia, Forenede Stater, 30291
        • Rekruttering
        • Rophe Adult and Pediatric Medicine
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rekruttering
        • Northwestern Medical Group
      • Chicago, Illinois, Forenede Stater, 60608
        • Rekruttering
        • EmVenio Research - Chicago
      • Chicago, Illinois, Forenede Stater, 60602
        • Rekruttering
        • Synexus Clinical Research - Chicago (DRS)
      • Chicago, Illinois, Forenede Stater, 60611-2605
        • Rekruttering
        • Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology
      • Chicago, Illinois, Forenede Stater, 60637
        • Rekruttering
        • UChicago Medicine - Comer Children's Hospital
      • Evergreen Park, Illinois, Forenede Stater, 60805
        • Rekruttering
        • NANI Research LLC - Evergreen Park IL
      • Hines, Illinois, Forenede Stater, 60141
        • Rekruttering
        • Edward Hines Jr VA Hospital
      • Palos Hills, Illinois, Forenede Stater, 60465
        • Afsluttet
        • Essential Concepts Research Solutions
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46804
        • Rekruttering
        • NANI Research LLC - Fort Wayne IN
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Rekruttering
        • IU School of Medicine - Nephrology
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Afsluttet
        • Nephrology Physicians, LLC
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Rekruttering
        • University of Iowa Health Care Medical Center- Nephrology
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Afsluttet
        • Clinical & Translational Science Unit (CTSU) - Nephrology
      • Overland Park, Kansas, Forenede Stater, 66210
        • Afsluttet
        • Premier Clinical Research
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Rekruttering
        • Renal Associates of Baton Rouge
      • Metairie, Louisiana, Forenede Stater, 70006
        • Rekruttering
        • LCMC Health
      • Natchitoches, Louisiana, Forenede Stater, 71457
        • Afsluttet
        • Barnum Medical Research - Bienville St
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Rekruttering
        • Ochsner Medical Center - New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Afsluttet
        • Louisiana Clinical and Translational Science (LA CaTS) Center
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Rekruttering
        • University Medical Center - New Orleans - Nephrology
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Rekruttering
        • Louisiana State University Health Shreveport
      • Shreveport, Louisiana, Forenede Stater, 71101
        • Rekruttering
        • Northwest Louisiana Nephrology, LLC
      • West Monroe, Louisiana, Forenede Stater, 71291
        • Rekruttering
        • Monroe Research, LLC
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • Rekruttering
        • Javara Inc./Privia Medical Group - Annapolis, MD
      • Baltimore, Maryland, Forenede Stater, 21201
        • Afsluttet
        • University of Maryland Medical Center - General Clinical Research Center
      • Baltimore, Maryland, Forenede Stater, 21287
        • Rekruttering
        • The Johns Hopkins University - Johns Hopkins Hospital - Nephrology
      • Gaithersburg, Maryland, Forenede Stater, 20879
        • Rekruttering
        • Mid-Atlantic Permanente Research Institute
      • Lutherville, Maryland, Forenede Stater, 21093
        • Rekruttering
        • Patient First Clinical Trials
      • Oxon Hill, Maryland, Forenede Stater, 20745
        • Rekruttering
        • MD Medical Research
      • Silver Spring, Maryland, Forenede Stater, 20901
        • Rekruttering
        • Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Rekruttering
        • Boston Medical Center
      • Boston, Massachusetts, Forenede Stater, 02111
        • Rekruttering
        • Tufts Medical Center
      • Boston, Massachusetts, Forenede Stater, 02215
        • Rekruttering
        • Beth Israel Deaconess Medical Center - Nephrology
      • Roxbury, Massachusetts, Forenede Stater, 02120
        • Rekruttering
        • Whittier Street Health Center
      • Springfield, Massachusetts, Forenede Stater, 01107
        • Afsluttet
        • Renal and Transplant Associates of New England, PC
      • West Springfield, Massachusetts, Forenede Stater, 01089
        • Rekruttering
        • Kidney Care and Transplant Services of New England - West Springfield
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Rekruttering
        • A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center
      • Detroit, Michigan, Forenede Stater, 48202
        • Rekruttering
        • Henry Ford Health System - Nephrology
      • Farmington Hills, Michigan, Forenede Stater, 48334
        • Afsluttet
        • Quest Research Institute
      • Flint, Michigan, Forenede Stater, 48504
        • Rekruttering
        • AA Medical Research Center
      • Lansing, Michigan, Forenede Stater, 48912
        • Rekruttering
        • Sparrow Clinical Research Institute
      • Roseville, Michigan, Forenede Stater, 48066
        • Afsluttet
        • St. Clair Nephrology Research
      • Saint Clair Shores, Michigan, Forenede Stater, 48081
        • Rekruttering
        • Center for Advanced Kidney Research
    • Minnesota
      • Edina, Minnesota, Forenede Stater, 55435
        • Afsluttet
        • InterMed Consultants - Edina Clinic
      • Minneapolis, Minnesota, Forenede Stater, 55417
        • Afsluttet
        • Minneapolis VA Healthcare System
    • Mississippi
      • Columbus, Mississippi, Forenede Stater, 39705
        • Rekruttering
        • Nephrology Associates, P.C. - Columbus
      • Fayette, Mississippi, Forenede Stater, 39069
        • Rekruttering
        • Prime Health and Wellness
      • Grenada, Mississippi, Forenede Stater, 38901
        • Afsluttet
        • UMMC Grenada Hospital
      • Jackson, Mississippi, Forenede Stater, 39216
        • Afsluttet
        • G.V. (Sonny) Montgomery VAMC
      • Olive Branch, Mississippi, Forenede Stater, 38654
        • Rekruttering
        • Olive Branch Family Medical Center
      • Ridgeland, Mississippi, Forenede Stater, 39157
        • Rekruttering
        • Sky Integrative Medical Center
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Rekruttering
        • Nephrology and Hypertension Associates - Tupelo
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • St. Louis Children's Hospital - Nephrology
      • St Louis, Missouri, Forenede Stater, 63136
        • Rekruttering
        • St. Louis Heart and Vascular, P.C.
      • St Louis, Missouri, Forenede Stater, 63104
        • Afsluttet
        • Center for Specialized Medicine - Nephrology
      • St Louis, Missouri, Forenede Stater, 63108
        • Rekruttering
        • Barnes-Jewish Center for Outpatient Health
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Trukket tilbage
        • Nevada Kidney Disease and Hypertension Centers
      • Las Vegas, Nevada, Forenede Stater, 89107
        • Rekruttering
        • DaVita Kidney Care - Las Vegas
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Rekruttering
        • CUH - Sheridan Pavilion - Three Cooper Plaza
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Rekruttering
        • Hackensack University Medical Center
      • Hamilton, New Jersey, Forenede Stater, 08690
        • Rekruttering
        • Bioluminux Clinical Research New Jersey
      • Neptune City, New Jersey, Forenede Stater, 07753
        • Rekruttering
        • Jersey Shore University Medical Center
      • Newark, New Jersey, Forenede Stater, 07103
        • Rekruttering
        • Rutgers Doctors Office Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • Afsluttet
        • Renal Medicine Associates
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • Afsluttet
        • New Mexico VA Healthcare System
    • New York
      • Brooklyn, New York, Forenede Stater, 11203
        • Rekruttering
        • SUNY Downstate Health Sciences University
      • Brooklyn, New York, Forenede Stater, 11203
        • Rekruttering
        • Kings County Hospital
      • Brooklyn, New York, Forenede Stater, 11221
        • Afsluttet
        • Clindove Research LLC
      • Flushing, New York, Forenede Stater, 11365
        • Rekruttering
        • New York Presbyterian Queens
      • Great Neck, New York, Forenede Stater, 11021
        • Rekruttering
        • Zucker School of Medicine
      • Laurelton, New York, Forenede Stater, 11413
        • Rekruttering
        • Scott Research, Inc.
      • New York, New York, Forenede Stater, 10037
        • Rekruttering
        • NYC Health + Hospital/Harlem
      • New York, New York, Forenede Stater, 10016
        • Rekruttering
        • Grossman School of Medicine
      • New York, New York, Forenede Stater, 10017
        • Afsluttet
        • Synexus Clinical Research - New York (DRS)
      • New York, New York, Forenede Stater, 10021
        • Rekruttering
        • The Rogosin Kidney Center
      • New York, New York, Forenede Stater, 10029
        • Rekruttering
        • Icahn School of Medicine at Mount Sinai - Nephrology
      • New York, New York, Forenede Stater, 10032
        • Rekruttering
        • General Nephrology Clinic - New York City
      • New York, New York, Forenede Stater, 10010
        • Afsluttet
        • VA New York Harbor Healthcare System
      • The Bronx, New York, Forenede Stater, 10468
        • Rekruttering
        • James J. Peters VA Medical Center
      • The Bronx, New York, Forenede Stater, 10461
        • Afsluttet
        • Kidney Medical Associates, PLLC
      • The Bronx, New York, Forenede Stater, 10461
        • Rekruttering
        • Montefiore Einstein - Albert Einstein College of Medicine
      • The Bronx, New York, Forenede Stater, 10467
        • Rekruttering
        • Montefiore Einstein Hospital - Moses Campus
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27511
        • Rekruttering
        • North Carolina Nephrology P.A. - Cary
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7155
        • Rekruttering
        • UNC Clinical and Translational Research Center
      • Charlotte, North Carolina, Forenede Stater, 28208
        • Rekruttering
        • Metrolina Nephrology Associates - Freedom Dr
      • Durham, North Carolina, Forenede Stater, 27710
        • Rekruttering
        • Duke University Hospital - Children's Health Center
      • Greenville, North Carolina, Forenede Stater, 27834
        • Rekruttering
        • Eastern Nephrology Associates - Greenville Office
      • Jacksonville, North Carolina, Forenede Stater, 28546
        • Rekruttering
        • Eastern Nephrology Associates - Jacksonville Office
      • Kinston, North Carolina, Forenede Stater, 28504
        • Rekruttering
        • Eastern Nephrology Associates - Kinston Office
      • New Bern, North Carolina, Forenede Stater, 28562
        • Rekruttering
        • Eastern Nephrology Associates - New Bern Office
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Rekruttering
        • Eastern Nephrology Associates - Wilmington Office
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Afsluttet
        • Brookview Hills Research Associates
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45220
        • Afsluttet
        • Cincinnati VA Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45206
        • Rekruttering
        • UC - DCI McMillan Research Unit
      • Cleveland, Ohio, Forenede Stater, 44106
        • Rekruttering
        • Louis Stokes Cleveland VA Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Rekruttering
        • Cleveland Clinic - Main Campus
      • Cleveland, Ohio, Forenede Stater, 44106
        • Rekruttering
        • UH Cleveland Medical Center - Nephrology
      • Columbus, Ohio, Forenede Stater, 43201
        • Rekruttering
        • Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Rekruttering
        • Lewis Katz School of Medicine at Temple University - Section of Nephrology
      • Philadelphia, Pennsylvania, Forenede Stater, 19141
        • Rekruttering
        • Jefferson Einstein Philadelphia Hospital - Nephrology
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Afsluttet
        • Jefferson Health - 33 South 9th Street
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Aktiv, ikke rekrutterende
        • Children's Hospital of Pittsburgh - Nephrology
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02915
        • Rekruttering
        • Lifespan Clinical Research Center
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29412
        • Rekruttering
        • Pharmacorp Clinical Trials, Inc
      • Charleston, South Carolina, Forenede Stater, 29425
        • Rekruttering
        • Medical University of South Carolina - Pulmonology
      • Columbia, South Carolina, Forenede Stater, 29203
        • Rekruttering
        • Columbia Nephrology Associates, PA
      • Spartanburg, South Carolina, Forenede Stater, 29306
        • Rekruttering
        • Carolina Nephrology, PA
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Rekruttering
        • Southeast Renal Research Institute
      • Memphis, Tennessee, Forenede Stater, 38119
        • Rekruttering
        • CNS Healthcare - Memphis
      • Memphis, Tennessee, Forenede Stater, 38105
        • Rekruttering
        • Le Bonheur Children's Hospital - Outpatient Clinic
      • Nashville, Tennessee, Forenede Stater, 37212
        • Rekruttering
        • Nashville VA Medical Center
      • Nashville, Tennessee, Forenede Stater, 37208
        • Rekruttering
        • Nashville General Hospital - Meharry Medical College - Nephrology
      • Nashville, Tennessee, Forenede Stater, 37232
        • Rekruttering
        • Nephrology Clinical Trials Center
    • Texas
      • Arlington, Texas, Forenede Stater, 76015
        • Afsluttet
        • Arlington Nephrology
      • Arlington, Texas, Forenede Stater, 76002
        • Afsluttet
        • Dallas Renal Group - Mansfield
      • Dallas, Texas, Forenede Stater, 75230
        • Rekruttering
        • Zenos Clinical Research
      • Dallas, Texas, Forenede Stater, 75246
        • Rekruttering
        • Dallas Nephrology Associates - Dallas Landry Office
      • Dallas, Texas, Forenede Stater, 75325
        • Rekruttering
        • Southwest Family Medicine Associates (SFMA) - Dallas
      • Dallas, Texas, Forenede Stater, 75204
        • Rekruttering
        • Baylor Scott and White Research Institute - Nephrology
      • Dallas, Texas, Forenede Stater, 75230
        • Rekruttering
        • Dallas Renal Group- Dallas
      • Dallas, Texas, Forenede Stater, 75231
        • Afsluttet
        • Nephrotex Research Group
      • Dallas, Texas, Forenede Stater, 75237
        • Rekruttering
        • Dallas Renal Group - Liberty Dallas Dialysis Center
      • Dallas, Texas, Forenede Stater, 75390
        • Rekruttering
        • UTSW Medical Center - Nephrology
      • El Paso, Texas, Forenede Stater, 79925
        • Rekruttering
        • Davita Clinical Research - El Paso
      • Fort Worth, Texas, Forenede Stater, 76104
        • Rekruttering
        • Cook Children's Medical Center
      • Houston, Texas, Forenede Stater, 77074
        • Afsluttet
        • Houston Medical Research Institute, LLC
      • Houston, Texas, Forenede Stater, 77090
        • Afsluttet
        • Clinical Research Strategies - Romano North Main Office
      • Houston, Texas, Forenede Stater, 77054
        • Rekruttering
        • Prolato Clinical Research Center - Kirby Dr
      • Houston, Texas, Forenede Stater, 77099
        • Afsluttet
        • Frenova-Southwest Houston
      • Houston, Texas, Forenede Stater, 77054
        • Afsluttet
        • Ronald Ralph MD PA
      • Lewisville, Texas, Forenede Stater, 75067
        • Rekruttering
        • Prime Clinical Research Inc - Lewisville
      • Lewisville, Texas, Forenede Stater, 75057
        • Afsluttet
        • NTKDA Lewisville
      • Lubbock, Texas, Forenede Stater, 79430
        • Rekruttering
        • Texas Tech University Health Sciences Center
      • Mansfield, Texas, Forenede Stater, 76063
        • Rekruttering
        • Prime Clinical Research - Mansfield - Regency Parkway
      • San Antonio, Texas, Forenede Stater, 78229
        • Trukket tilbage
        • San Antonio Kidney Disease Center Physicians Group - Medical Center
      • San Antonio, Texas, Forenede Stater, 78229
        • Afsluttet
        • University of Texas Health Science Center - Nephrology
      • San Antonio, Texas, Forenede Stater, 78251
        • Afsluttet
        • San Antonio Kidney Disease Center Physicians Group - Westover Hills
      • Shenandoah, Texas, Forenede Stater, 77384
        • Rekruttering
        • Kidney Specialists of N Houston, PLLC
      • The Woodlands, Texas, Forenede Stater, 77384
        • Rekruttering
        • Renal Research of Montgomery County, PLLC
      • Webster, Texas, Forenede Stater, 77598
        • Rekruttering
        • Tranquil Clinical Research
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Rekruttering
        • UVA Health - Nephrology Clinical Research Center
      • Norfolk, Virginia, Forenede Stater, 23504
        • Afsluttet
        • York Clinical Research, LLC
      • Norfolk, Virginia, Forenede Stater, 23504
        • Rekruttering
        • Tidewater Kidney Specialists - Church St.
      • Richmond, Virginia, Forenede Stater, 23298
        • Rekruttering
        • Virginia Commonwealth University - Division of Nephrology
      • Richmond, Virginia, Forenede Stater, 23249
        • Rekruttering
        • McGuire Research Institute, Inc. (151)
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Afsluttet
        • Nephrology Associates of Tidewater, LTD
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • Rekruttering
        • UW Medical Center - Montlake - Nephrology
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Rekruttering
        • Medical College of Wisconsin - Pulmonology
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Rekruttering
        • Milwaukee Nephrologists - Wauwatosa
  • Frankrig
      • Créteil, Frankrig
        • Rekruttering
        • Hopital Henri Mondor - Nephrology
      • Grenoble, Frankrig
        • Rekruttering
        • Hospital Nord Michallon - Nephrology
      • Le Kremlin-Bicêtre, Frankrig
        • Rekruttering
        • Bicetre Hospital
      • Limoges, Frankrig
        • Rekruttering
        • CHU Dupuytren 2 - Néphrologie, dialyse, transplantations
      • Marseille, Frankrig
        • Rekruttering
        • Hôpital de la Conception
      • Paris, Frankrig
        • Rekruttering
        • Ambroise Paré Hospital
      • Paris, Frankrig
        • Rekruttering
        • Hopital Necker Enfants Malades - Nephrology
      • Paris, Frankrig
        • Afsluttet
        • Hopital Tenon
      • Paris, Frankrig
        • Afsluttet
        • Université Paris-Descartes / Hôpital Européen Georges Pompidou
      • Pointe à Pitre, Frankrig
        • Rekruttering
        • CHU de Guadeloupe
      • Saint-Ouen, Frankrig
        • Rekruttering
        • AURA Nord
      • Toulouse, Frankrig
        • Afsluttet
        • Hopital de Rangueil
  • Ghana
      • Accra, Ghana
        • Rekruttering
        • University of Ghana Medical School - Nephrology
      • Cantonments, Ghana
        • Rekruttering
        • The Bank Hospital
      • Kumasi, Ghana
        • Rekruttering
        • Komfo Anokye Teaching Hospital - Nephrology
  • Holland
      • Amsterdam, Holland
        • Afsluttet
        • Amsterdam UMC - Amsterdam Public Health Research Institute
  • Nigeria
      • Enugu, Nigeria
        • Rekruttering
        • University of Nigeria Teaching Hospital
      • Ibadan, Nigeria
        • Rekruttering
        • University College Hospital
      • Idi-Araba, Nigeria
        • Rekruttering
        • Lagos University Teaching Hospital
      • Ikeja, Nigeria
        • Rekruttering
        • Lagos State University Teaching Hospital
      • Lagos, Nigeria
        • Rekruttering
        • Nigerian Institute of Medical Research
  • Portugal
      • Amadora, Portugal
        • Afsluttet
        • Unidade Local de Saude Amadora/Sintra, E.P.E.
      • Lisbon, Portugal
        • Afsluttet
        • Hospital Curry Cabral - Serviço de Nefrologia
      • Lisbon, Portugal
        • Afsluttet
        • Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology
      • Loures, Portugal
        • Afsluttet
        • Unidade Local de Saúde de Loures-Odivelas, E.P.E.
  • Puerto Rico
      • Mayagüez, Puerto Rico, 06680
        • Rekruttering
        • FDI Clinical Research
      • Rio Piedras, Puerto Rico, 00935
        • Rekruttering
        • University of Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Afsluttet
        • GCM Medical Group, PSC
  • Spanien
      • Barcelona, Spanien
        • Afsluttet
        • Hospital Clinic de Barcelona - Nephrology
      • Barcelona, Spanien
        • Afsluttet
        • Hospital Universitari Vall d´Hebron - Servicio de Pediatria
      • Córdoba, Spanien
        • Afsluttet
        • Reina Sofia University Hospital - Nephrology
      • Madrid, Spanien
        • Afsluttet
        • Hospital Universitario 12 de Octubre - Nephrology
      • Seville, Spanien
        • Afsluttet
        • Hospital Universitario Virgen Macarena

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Nøgleinklusionskriterier:

  • APOL1 genotype af G1/G1, G2/G2 eller G1/G2
  • Proteinurisk nyresygdom

Nøgleekskluderingskriterier:

  • Fast organ- eller knoglemarvstransplantation
  • Ukontrolleret hypertension
  • Diagnose af diabetes mellitus
  • Kendt underliggende årsag til nyresygdom, herunder men ikke begrænset til seglcellesygdom

Andre protokoldefinerede Inklusions-/Eksklusionskriterier gælder.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Del A (Fase 2/3): VX-147
Deltagerne vil blive randomiseret til at modtage forskellige doser af VX-147.
Deltagerne vil modtage den valgte dosis af VX-147 i mindst 96 uger.
Medicin: VX-147
Tabletter til oral administration.
Placebo komparator: Del A (fase 2/3): Placebo
Deltagerne vil modtage placebo matchet til VX-147.
Medicin: Placebo
Tabletter til oral administration.
Eksperimentel: Del B (Fase 3): VX-147
Deltagere, der gennemfører del A, vil modtage VX-147 i yderligere 96 uger.
Medicin: VX-147
Tabletter til oral administration.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Del A: Procentvis ændring fra baseline i urinprotein til kreatininforhold (UPCR) ved uge 48 (vurderet ved den midlertidige analyse i uge 48)
Tidsramme: Fra baseline til uge 48
Fra baseline til uge 48
Del A: Estimerede glomerulære filtrationsrate (eGFR) hældning vurderet ved mellemliggende analyse
Tidsramme: Fra baseline gennem ≥ uge 48
Fra baseline gennem ≥ uge 48
Del A: eGFR-hældning vurderet ved endelig analyse
Tidsramme: Fra baseline gennem studiefærdiggørelse (Mindst 2 års eGFR-data vurderet ved den endelige analyse)
Fra baseline gennem studiefærdiggørelse (Mindst 2 års eGFR-data vurderet ved den endelige analyse)
Del B: Sikkerhed og Tålelighed som vurderet ved antallet af deltagere med bivirkninger (AEs) og alvorlige bivirkninger (SAEs)
Tidsramme: Dag 1 igennem studiefærdiggørelsen (cirka 4 år efter den sidste deltager er inkluderet)
Dag 1 igennem studiefærdiggørelsen (cirka 4 år efter den sidste deltager er inkluderet)

Sekundære resultatmål

Resultatmål
Tidsramme
Del A: Sikkerhed og tolerabilitet vurderet ud fra antal deltagere med bivirkninger (AEs) og alvorlige bivirkninger (SAEs)
Tidsramme: Dag 1 gennem studiefærdiggørelsen (ca. 2 år efter den sidste deltager er blevet inkluderet)
Dag 1 gennem studiefærdiggørelsen (ca. 2 år efter den sidste deltager er blevet inkluderet)
Del A: Maksimal plasmakoncentration (Cmax) af VX-147
Tidsramme: Dag 1 og uge 40
Dag 1 og uge 40
Del A: Areal under koncentrationskurven i forhold til tid under en doseringsinterval (AUCtau) for VX-147
Tidsramme: Dag 1 og uge 40
Dag 1 og uge 40
Del A: Observeret præ-dosis plasmakoncentration (Ctrough) for VX-147
Tidsramme: Dag 1 op til uge 40
Dag 1 op til uge 40
Del A: Acceptabilitet af tabletformuleringen af VX-147 hos børnedeltagere ved brug af bekvemmelighedsdomænet fra Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4
Tidsramme: Dag 1 og uge 48
Dag 1 og uge 48
Del B: Procentvis ændring fra baseline i UPCR over tid
Tidsramme: Fra baseline gennem studiet (ca. 4 år efter den sidste deltager er inkluderet)
Fra baseline gennem studiet (ca. 4 år efter den sidste deltager er inkluderet)
Del B: eGFR-hældningsvurdering
Tidsramme: Dag 1 gennem studiefærdiggørelsen (cirka 4 år efter den sidste deltager er inkluderet)
Dag 1 gennem studiefærdiggørelsen (cirka 4 år efter den sidste deltager er inkluderet)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vertex Pharmaceuticals Incorporated

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. marts 2022

Primær færdiggørelse (Anslået)

2. juni 2028

Studieafslutning (Anslået)

7. maj 2030

Datoer for studieregistrering

Først indsendt

28. marts 2022

Først indsendt, der opfyldte QC-kriterier

28. marts 2022

Først opslået (Faktiske)

6. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VX21-147-301
  • 2024-515633-15-00 (Anden identifikator: EU Trial (CTIS) Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Detaljer om Vertex datadelingskriterier og proces for at anmode om adgang kan findes på: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Proteinurisk nyresygdom

Kliniske forsøg med VX-147

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner