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Recruiting Phase 2 NCT07161037

Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)

Phase 2 – studying effectiveness and dosage
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Sponsor: Vertex Pharmaceuticals Incorporated

trial.available_in: БГ
Overview
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.
Who can participate
Key Inclusion Criteria: * A pre-existing diagnosis of ADPKD as defined in the protocol * Willing and able to comply with scheduled visits and other study procedures * Participants with ADPKD with Mayo imaging classification (MIC) status of 1B (with htTKV ≥250 mL/m), 1C, 1D, or 1E confirmed by abdominal MRI obtained during screening * Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73 square meter (m\^2) Key Exclusion Criteria: * History of kidney disease other than ADPKD that in the opinion of the investigator would independently impact the natural history of ADPKD * History of solid organ or bone marrow transplantation or nephrectomy * Ongoing renal replacement therapy or planning to start renal replacement therapy within 12 months of screening Other protocol defined Inclusion/Exclusion criteria will apply.
Interventions
VX-407
DRUG
Locations 40
Belgium (2)
Universite Catholique de Louvain - Nephrology
Brussels
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Nephrology
Leuven
Canada (1)
McGill University Health Centre
Montreal
France (2)
Centre Hospitalier Regional Universitaire (CHRU) Brest
Brest
Hopital Necker Enfants Malades - Neurology
Paris
Germany (2)
Charité - Klinik für Nephrologie und Intensivmedizin der
Berlin
University Hospital Cologne (Koeln) - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Cologne
Spain (2)
Fundacio Puigvert
Barcelona
Hospital Fundacion Jimenez Diaz
Madrid
United Kingdom (6)
Queen Elizabeth Hospital Birmingham
Birmingham
King's College Hospital - Pulmonology
London
Royal Free Hospital - Nephrology
London
St George's Hospital London - Nephrology
London
Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital - Nephrology
Newcastle upon Tyne
Northern General Hospital
Sheffield
United States (25)
Alabama Kidney Research
Alabaster , Alabama
Emory School of Medicine - Renal Division
Atlanta , Georgia
University of Maryland Medical Center - General Clinical Research Center
Baltimore , Maryland
UAB Nephrology Research at CH19
Birmingham , Alabama
Tufts Medical Center
Boston , Massachusetts
Beth Israel Deaconess Medical Center - Nephrology
Boston , Massachusetts
UVM Medical Center - 1 South Prospect Street
Burlington , Vermont
UChicago Medicine - Duchossois Center for Advanced Medicine - Nephrology
Chicago , Illinois
Cleveland Clinic - Main Campus
Cleveland , Ohio
Renal Associates
Columbus , Georgia
Geisinger Clinic
Danville , Pennsylvania
University of Iowa Health Care Medical Center- Nephrology
Iowa City , Iowa
Mayo Clinic - Jacksonville
Jacksonville , Florida
Clinical & Translational Science Unit (CTSU) - Nephrology
Kansas City , Kansas
DaVita Kidney Care - Las Vegas
Las Vegas , Nevada
Kaiser Permanente Los Angeles Medical Center
Los Angeles , California
Nephrology & Hypertension Associates, PC
Middlebury , Connecticut
University of Minnesota -Clinics and Surgery Center (CSC) - Endocrine Clinic
Minneapolis , Minnesota
Yale University - Yale Nephrology Clinical Research Clinic
New Haven , Connecticut
The Rogosin Kidney Center
New York , New York
General Nephrology Clinic - New York City
New York , New York
Perelman Center for Advanced Medicine - Nephrology
Philadelphia , Pennsylvania
Mayo Clinic - Rochester
Rochester , Minnesota
UCSF Clinical Research Center at Parnassus
San Francisco , California
Swedish Center for Comprehensive Care
Seattle , Washington
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
19.11.2025
Completion date
31.12.2027
Registry ID
NCT07161037
Source
clinicaltrials.gov
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