RecruitingPhase 2NCT07161037
Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
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
Sponsor
Vertex Pharmaceuticals Incorporated
Enrollment
24 participants
Start Date
Nov 19, 2025
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- 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)
Exclusion Criteria3
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGVX-407
Tablets for oral administration.
Locations(40)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07161037
Related Trials
RADIOLOGICAL AND CLINICAL EVALUATION OF RENAL EMBOLIZATION USING EVOH IN DIALYSIS PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A PROSPECTIVE LONGITUDINAL OBSERVATIONAL STUDY
NCT075353851 location
Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease
NCT074541741 location
Phase 1 Study to Evaluate the Safety and Tolerability of Intravenously Administered PYC-003
NCT067140069 locations
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
NCT072600711 location