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Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
Sponsor: Vertex Pharmaceuticals Incorporated
Summary
The purpose of the study is to evaluate the effect of VX-407 on height-adjusted total kidney volume (htTKV), safety, tolerability, and pharmacokinetics (PK) of VX-407.
Official title: A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-11-19
Completion Date
2027-12-31
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
VX-407
Tablets for oral administration.
Locations (38)
Alabama Kidney Research
Alabaster, Alabama, United States
UAB Nephrology Research at CH19
Birmingham, Alabama, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
UCSF Clinical Research Center at Parnassus
San Francisco, California, United States
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut, United States
Yale University - Yale Nephrology Clinical Research Clinic
New Haven, Connecticut, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Emory School of Medicine - Renal Division
Atlanta, Georgia, United States
Renal Associates
Columbus, Georgia, United States
UChicago Medicine - Duchossois Center for Advanced Medicine - Nephrology
Chicago, Illinois, United States
University of Iowa Health Care Medical Center- Nephrology
Iowa City, Iowa, United States
Clinical & Translational Science Unit (CTSU) - Nephrology
Kansas City, Kansas, United States
University of Maryland Medical Center - General Clinical Research Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center - Nephrology
Boston, Massachusetts, United States
University of Minnesota -Clinics and Surgery Center (CSC) - Endocrine Clinic
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
DaVita Kidney Care - Las Vegas
Las Vegas, Nevada, United States
General Nephrology Clinic - New York City
New York, New York, United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, United States
Geisinger Clinic
Danville, Pennsylvania, United States
Perelman Center for Advanced Medicine - Nephrology
Philadelphia, Pennsylvania, United States
UVM Medical Center - 1 South Prospect Street
Burlington, Vermont, United States
Universite Catholique de Louvain - Nephrology
Brussels, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Nephrology
Leuven, Belgium
McGill University Health Centre
Montreal, Canada
Centre Hospitalier Regional Universitaire (CHRU) Brest
Brest, France
Hopital Necker Enfants Malades - Neurology
Paris, France
Charité - Klinik für Nephrologie und Intensivmedizin der
Berlin, Germany
University Hospital Cologne (Koeln) - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Cologne, Germany
Fundacio Puigvert
Barcelona, Spain
Hospital Fundacion Jimenez Diaz
Madrid, Spain
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
King's College Hospital - Pulmonology
London, United Kingdom
Royal Free Hospital - Nephrology
London, United Kingdom
St George's Hospital London - Nephrology
London, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital - Nephrology
Newcastle upon Tyne, United Kingdom
Northern General Hospital
Sheffield, United Kingdom