Clinical trial NCT05312879: Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Proteinuric Kidney Disease
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 466
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)
timeFrame: From Baseline at Week 48
measure: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis
timeFrame: From Baseline Through >= Week 48
measure: eGFR Slope Assessed at Study Completion
timeFrame: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
Secondary outcomes:
measure: Time to Composite Clinical Outcome of a Sustained Decline of >=30 Percent (%) in eGFR, the Onset of end-stage Kidney Disease or Death
timeFrame: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
measure: Maximum Plasma Concentration (Cmax) of VX-147
timeFrame: Day 1 and Week 40
measure: Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147
timeFrame: Day 1 and Week 40
measure: Observed Pre-dose Plasma Concentration (Ctrough) of VX-147
timeFrame: Day 1 up to Week 40
measure: Acceptability Tablet Formulation of VX-147 in Pediatric Participants using the Convenience Domain of the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
timeFrame: Day 1 and Week 48
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Alabama Kidney Research
state: Alabama
city: Birmingham
country: United States
facility: EmVenio Research
state: Alabama
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - The Kirklin Clinic
state: Alabama
city: Fairhope
country: United States
facility: Nephrology Associates
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research LLC
state: Alabama
city: Huntsville
country: United States
facility: Nephrology Consultants, LLC
state: Alabama
city: Montgomery
country: United States
facility: Renal Associates of Alabama, LLC
state: Alabama
city: Vestavia Hills
country: United States
facility: EmVenio Research
state: Alabama
city: Mesa
country: United States
facility: AKDHC Medical Research Service LLC - Banner Desert Office
state: Arizona
city: Phoenix
country: United States
facility: AKDHC Medical Research Service LLC
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Cardiology and Medicine Clinic, P.A.
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Fresno
country: United States
facility: The Medical Research Group, Inc
state: California
city: Granada Hills
country: United States
facility: Amicis Research Center
state: California
city: Granada Hills
country: United States
facility: Renal Consultants Medical Group
state: California
city: Los Angeles
country: United States
facility: Eastside Clinical Research Associates
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente - Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Division of Nephrology
state: California
city: Orange
country: United States
facility: UCI Center for Clinical Research
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente, Sacramento
state: California
city: San Francisco
country: United States
facility: UCSF School of Medicine
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Victorville
country: United States
facility: Kidney and Hypertension Center
state: California
city: Bloomfield
country: United States
facility: Greater Hartford Nephrology
state: Connecticut
city: Middlebury
country: United States
facility: Nephrology & Hypertension Associates, PC
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Washington
country: United States
facility: The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension
state: District of Columbia
city: Bay Pines
country: United States
facility: Bay Pines Healthcare System
state: Florida
city: Bradenton
country: United States
facility: Nova Clinical Research, LLC
state: Florida
city: Brandon
country: United States
facility: Clinical Research of Brandon, LLC
state: Florida
city: Coral Gables
country: United States
facility: AMR-Miami
state: Florida
city: Coral Gables
country: United States
facility: Horizon Research Group, LLC
state: Florida
city: Coral Springs
country: United States
facility: South Florida Nephrology Group PA, Research Div.
state: Florida
city: Delray Beach
country: United States
facility: Delray Physician Care Center
state: Florida
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Gainesville
country: United States
facility: University of Florida, Shands Hospital
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach
state: Florida
city: Hialeah
country: United States
facility: Qway Research
state: Florida
city: Hollywood
country: United States
facility: Elixia Pines, LLC
state: Florida
city: Jacksonville
country: United States
facility: UF Health Cardiovascular Center - Jacksonville
state: Florida
city: Lauderdale Lakes
country: United States
facility: South Florida Research Institute
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research
state: Florida
city: Miami
country: United States
facility: Total Research Group, LLC
state: Florida
city: Miami
country: United States
facility: MedBio Trials
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Orlando
country: United States
facility: Accelerated Enrollment Solutions (AES) Orlando
state: Florida
city: Orlando
country: United States
facility: CTR Oakwater, LLC
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando, LLC
state: Florida
city: Sanford
country: United States
facility: Infigo Clinical Research
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Tampa
country: United States
facility: Elixia Tampa, LLC
state: Florida
city: Acworth
country: United States
facility: American Clinical Trials LLC - Acworth
state: Georgia
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia
state: Georgia
city: Atlanta
country: United States
facility: Emory School of Medicine - Renal Division
state: Georgia
city: Atlanta
country: United States
facility: Advanced Clinical Research of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Morehouse School of Medicine, Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics
state: Georgia
city: Atlanta
country: United States
facility: AES Atlanta (DRS)
state: Georgia
city: Atlanta
country: United States
facility: Fides Clinical Research
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical College of Georgia - Adult Sickle Cell Clinic
state: Georgia
city: Brunswick
country: United States
facility: Coastal Medical Research
state: Georgia
city: College Park
country: United States
facility: Randomize Now
state: Georgia
city: Columbus
country: United States
facility: Clincept - Warm Springs
state: Georgia
city: Columbus
country: United States
facility: Renal Associates, LLC
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Healthcare System
state: Georgia
city: Douglasville
country: United States
facility: American Clinical Trials LLC - Douglasville
state: Georgia
city: East Point
country: United States
facility: Southeast Kidney Associates
state: Georgia
city: Fayetteville
country: United States
facility: Javara Inc./Privia Medical Group Georgia, PLLC
state: Georgia
city: Lawrenceville
country: United States
facility: Georgia Nephrology
state: Georgia
city: Savannah
country: United States
facility: Javara Inc./Privia Medical Group Georgia, LLC
state: Georgia
city: Tyrone
country: United States
facility: Inova Clinical Trials and Research Center
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine
state: Georgia
city: Chicago
country: United States
facility: AES Chicago (DRS)
state: Illinois
city: Chicago
country: United States
facility: EmVenio Research - Chicago
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: EmVenio Research
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evergreen Park
country: United States
facility: NANI Research LLC
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr VA Hospital
state: Illinois
city: Palos Hills
country: United States
facility: Essential Concepts Research Solutions
state: Illinois
city: Fort Wayne
country: United States
facility: NANI Research LLC - Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Mishawaka
country: United States
facility: Nephrology Physicians, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Premier Clinical Research
state: Kansas
city: Baton Rouge
country: United States
facility: Renal Associates of Baton Rouge
state: Louisiana
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Natchitoches
country: United States
facility: Barnum Medical Research
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center LSUHSC
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center - New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center - New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology, LLC - Shreveport
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Shreveport
state: Louisiana
city: West Monroe
country: United States
facility: Monroe Research, LLC
state: Louisiana
city: Annapolis
country: United States
facility: Javara Inc./Privia Medical Group, LLC MidAtlantic - Main Research Site
state: Maryland
city: Baltimore
country: United States
facility: General Clinical Research Center, University of Maryland Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Gaithersburg
country: United States
facility: Kaiser Permanente, Mid-Atlantic
state: Maryland
city: Nottingham
country: United States
facility: Patient First Clinical Trials
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Silver Spring
country: United States
facility: Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MD
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Roxbury
country: United States
facility: Whittier Street Health Center
state: Massachusetts
city: Springfield
country: United States
facility: Renal and Transplant Associates of New England, PC
state: Massachusetts
city: West Springfield
country: United States
facility: Kidney Care and Transplant Services of New England
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System - A. Alfred Taubman Health Care Center - Nephrology Clinic
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Flint
country: United States
facility: AA Medical Research Center
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Roseville
country: United States
facility: St. Clair Nephrology Research
state: Michigan
city: Saint Clair Shores
country: United States
facility: Center for Advanced Kidney Research
state: Michigan
city: Edina
country: United States
facility: InterMed Consultants/ Davita Clinical Research
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis VA Healthcare System
state: Minnesota
city: Columbus
country: United States
facility: Nephrology Associates, P.C.
state: Mississippi
city: Fayette
country: United States
facility: Prime Health and Wellness
state: Mississippi
city: Grenada
country: United States
facility: University of Mississippi
state: Mississippi
city: Jackson
country: United States
facility: G.V. (Sonny) Montgomery VAMC
state: Mississippi
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center
state: Mississippi
city: Tupelo
country: United States
facility: Nephrology and Hypertension Associates, LTD
state: Mississippi
city: Saint Louis
country: United States
facility: Center for Specialized Medicine - SSM Health Saint Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine - ADULT
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Saint Louis
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular, P.C.
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Kidney Disease and Hypertension Centers
state: Nevada
city: Las Vegas
country: United States
facility: DaVita Clinical Research
state: Nevada
city: Camden
country: United States
facility: Cooper University Healthcare
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hamilton
country: United States
facility: Bioluminux Clinical Research New Jersey
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico VA Healthcare System
state: New Mexico
city: Albuquerque
country: United States
facility: Renal Medicine Associates
state: New Mexico
city: Bronx
country: United States
facility: Albert Einstein Hospital - Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: Kidney Medical Associates, PLLC
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
city: Brooklyn
country: United States
facility: Kings County Hospital
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
city: Brooklyn
country: United States
facility: Clindove Research LLC
state: New York
city: Flushing
country: United States
facility: Nephrology Associates, P.C. - Queens
state: New York
city: Great Neck
country: United States
facility: Zucker School of Medicine at Hofstra/Northwell
state: New York
city: Laurelton
country: United States
facility: Scott Research, Inc.
state: New York
city: New York
country: United States
facility: VA New York Harbor Healthcare System
state: New York
city: New York
country: United States
facility: New York University Grossman School of Medicine
state: New York
city: New York
country: United States
facility: AES New York (DRS)
state: New York
city: New York
country: United States
facility: The Rogosin Institute - The Rogosin Kidney Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University - Division of Nephrology
state: New York
city: New York
country: United States
facility: NYC Health + Hospital/Harlem
state: New York
city: Cary
country: United States
facility: North Carolina Nephrology P.A. - Cary Office
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Clinical and Translational Research Center
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates
state: North Carolina
city: Durham
country: United States
facility: DUHS Children's Health Center T0909
state: North Carolina
city: Greenville
country: United States
facility: Eastern Nephrology Associates - Greenville Office
state: North Carolina
city: Jacksonville
country: United States
facility: Eastern Nephrology Associates - Jacksonville Office
state: North Carolina
city: Kinston
country: United States
facility: Eastern Nephrology Associates - Kinston Office
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephrology Associates - New Bern Office
state: North Carolina
city: Wilmington
country: United States
facility: Eastern Nephrology Associates - Wilmington Office
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: VA Cleveland Northeast Ohio Healthcare System
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center (NDKD)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: East Providence
country: United States
facility: Lifespan Clinical Research Center
state: Rhode Island
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials, Inc
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina - Nexus Research Clinic
state: South Carolina
city: Columbia
country: United States
facility: Columbia Nephrology Associates, PA
state: South Carolina
city: Spartanburg
country: United States
facility: Carolina Nephrology, PA
state: South Carolina
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital - Outpatient Clinic
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions (CNS Healthcare) - Memphis Research Center
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: Nashville VA Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Nephrology Clinical Trials Center
state: Tennessee
city: Arlington
country: United States
facility: Dallas Renal Group - Arlington
state: Texas
city: Arlington
country: United States
facility: Arlington Nephrology
state: Texas
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: Dallas
country: United States
facility: Nephrotex Research Group/Texas Kidney Institute
state: Texas
city: Dallas
country: United States
facility: Dallas Renal Group - 1
state: Texas
city: Dallas
country: United States
facility: Dallas Nephrology Associates - Dallas Landry Office
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates (SFMA) - Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Davita Clinical Research - El Paso
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Ronald Ralph MD PA
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Institute, LLC
state: Texas
city: Houston
country: United States
facility: Clinical Research Strategies - Romano North Main Office
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research, Ltd
state: Texas
city: Lewisville
country: United States
facility: North Texas Kidney Disease Associates
state: Texas
city: Lewisville
country: United States
facility: Prime Clinical Research Inc - Lewisville
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Mansfield
country: United States
facility: Prime Clinical Research
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health San Antonio
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney
state: Texas
city: Shenandoah
country: United States
facility: Kidney Specialists of N Houston, PLLC
state: Texas
city: The Woodlands
country: United States
facility: Renal Physicians of Montgomery County, PA
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health - Nephrology Clinical Research Center
state: Virginia
city: Norfolk
country: United States
facility: TKS Research, P.L.L.C.
state: Virginia
city: Norfolk
country: United States
facility: York Clinical Research, LLC
state: Virginia
city: Richmond
country: United States
facility: Richmond VAMC
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University - Division of Nephrology
state: Virginia
city: Virginia Beach
country: United States
facility: Nephrology Associates of Tidewater, LTD
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Wauwatosa
country: United States
facility: Milwaukee Nephrologists - Wauwatosa
state: Wisconsin
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Brussels
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Aracaju
country: Brazil
facility: Centro de Pesquisa Clinica do Coracao
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de Belo Horizonte
city: Botucatu
country: Brazil
facility: Upeclin - UNESP Botucatu - CKD and Hypertension Department
city: Botucatu
country: Brazil
facility: Upeclin - UNESP Botucatu - Kidney Transplantation Department
city: Campinas
country: Brazil
facility: IPECC - Instituto de Pesquisa Clinica de Campinas
city: Curitiba
country: Brazil
facility: Instituto Pro-Renal
city: Curitiba
country: Brazil
facility: PUC Trials - Unidade Epicenter
city: Fortaleza
country: Brazil
facility: Hospital Universitário Valter Cantídio
city: Fortaleza
country: Brazil
facility: Instituto de Ensino e Pesquisa Clinica do Ceara
city: Goiania
country: Brazil
facility: Federal University of Goiás (UFG)
city: Juiz de Fora
country: Brazil
facility: Cmip-Centro Mineiro de Pesquisa Ltda
city: Juiz De Fora
country: Brazil
facility: Galileo Medical Research Ltda
city: Marilia
country: Brazil
facility: ICM - Instituto do Coracao de Marilia
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: UFRS - Hospital de Clínicas
city: Recife
country: Brazil
facility: Centro de Pesquisa Clinica Professor Salomao Kelner
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital São Lucas
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto
city: Rio de Janeiro
country: Brazil
facility: Pedro Ernesto University Hospital
city: Salvador
country: Brazil
facility: CSB Group of Nephrology Brazil
city: Salvador
country: Brazil
facility: Federal University of Bahia
city: Salvador
country: Brazil
facility: Hospital Ana Nery/SESAB
city: Santo Andre
country: Brazil
facility: Praxis Pesquisa Medica
city: Sao Paulo
country: Brazil
facility: Hospital Nove de Julho
city: Sao Paulo
country: Brazil
facility: Irmandade Da Santa Casa De Misericordia De Sao Paulo
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
city: São Paulo
country: Brazil
facility: Hospital do Rim - Fundação Oswaldo Ramos - Ambulatorio NEFRITE
city: São Paulo
country: Brazil
facility: University of Sao Paulo
city: Montreal
country: Canada
facility: Recherche GCP Research
city: Toronto
country: Canada
facility: Women's College Hospital
city: Atlántico
country: Colombia
facility: Clinica de La Costa S.A.S
city: Bogota
country: Colombia
facility: Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO
city: Cali
country: Colombia
facility: Fundación Valle Del Lili
city: Cartagena
country: Colombia
facility: Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS
city: Ibague
country: Colombia
facility: Mediservis del Tolima IPS S.A.S.
city: Medellin
country: Colombia
facility: Promotora Medica Las Americas S.A. - Clinica Las Americas
city: Medellín
country: Colombia
facility: Fundación Hospitalaria San Vicente de Paul
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Grenoble
country: France
facility: CHU Grenoble Alpes - Hôpital Nord Michallon
city: Le Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre AP-HP
city: Limoges
country: France
facility: CHU Dupuytren 2
city: Marseille
country: France
facility: Hôpital de la Conception, Centre de néphrologie et transplantation rénale
city: Paris
country: France
facility: Ambroise Paré Hospital
city: Paris
country: France
facility: Hopitaux Universitaires Est Parisien - Hopital Tenon
city: Paris
country: France
facility: Service de Nephrologie - Hopital Universitaire Necker
city: Paris
country: France
facility: Université Paris-Descartes / Hôpital Européen Georges Pompidou
city: Pointe-à-Pitre Cedex
country: France
facility: CHU de Guadeloupe
city: Saint-Ouen
country: France
facility: AURA Nord Saint Ouen
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire CHU de Toulouse Hopital de Rangueil
city: Accra
country: Ghana
facility: University of Ghana Medical School
city: Cantonments
country: Ghana
facility: The Bank Hospital
city: Kumasi
country: Ghana
facility: Komfo Anokye Teaching Hospital
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
city: Enugu
country: Nigeria
facility: University of Nigeria Teaching Hospital
city: Ibadan
country: Nigeria
facility: University College Hospital
city: Idi-Araba
country: Nigeria
facility: Lagos University Teaching Hospital
city: Ikeja
country: Nigeria
facility: Lagos State University Teaching Hospital
city: Yaba
country: Nigeria
facility: Nigerian Institute of Medical Research
city: Amadora
country: Portugal
facility: Unidade Autónoma de Nefrologia
city: Lisboa
country: Portugal
facility: Department of Nephrology and Renal Transplant
city: Lisboa
country: Portugal
facility: Hospital Curry Cabral
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Mayaguez
country: Puerto Rico
facility: FDI Clinical Research
city: Rio Piedras
country: Puerto Rico
facility: Alliance, School of Medicine
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Córdoba
country: Spain
facility: Reina Sofia University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Basildon
country: United Kingdom
facility: Basildon University Hospital Renal Department
city: Bellshill
country: United Kingdom
facility: AES Glasgow (DRS)
city: Birmingham
country: United Kingdom
facility: AES Midlands (DRS)
city: Birmingham
country: United Kingdom
facility: FutureMeds Birmingham
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
city: Carshalton
country: United Kingdom
facility: Epsom and St Helier University Hospitals NHS Trust - St Helier Hospital - South West SW Thames Institute for Renal Research
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust - Leicester General Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust, The Royal London Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
city: London
country: United Kingdom
facility: Guy's & St Thomas NHS Foundation Trust, Guy's Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Royal Free NHS Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: St Pancras Clinical Research
city: Manchester
country: United Kingdom
facility: AES NW Consortium Manchester (DRS)
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: The Medicines Evaluation Unit
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, Children's Clinical Research Facility
Study officials:
References: