NCT07161037Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 29 Aug 2025
- Start date
- 19 Nov 2025
- Primary completion date
- 22 Jul 2027
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Polycystic kidney disease
- NCT number
- NCT07161037
- EU CT number
- 2024-517393-13-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 26
- From 19 Nov 2025 to the primary completion date, 22 Jul 2027
- 43 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing renal replacement therapy or planning to start renal replacement therapy within 12 months of screening
- Other protocol defined Inclusion/Exclusion criteria will apply.
Other illness
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (43)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Active, not recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Fundació Puigvert Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Active, not recruiting |
| Queen Elizabeth Hospital Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| King's College Hospital - Pulmonology Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| St George's Hospital London - Nephrology Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Free Hospital - Nephrology Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital - Nephrology Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Northern General Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Alabama Kidney Research Coordinator of this site? Confirm its status | Alabaster | United States | Unknown status |
| Emory School of Medicine - Renal Division Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Maryland Medical Center - General Clinical Research Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| UAB Nephrology Research at CH19 Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Beth Israel Deaconess Medical Center - Nephrology Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| UVM Medical Center - 1 South Prospect Street Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| UChicago Medicine - Duchossois Center for Advanced Medicine - Nephrology Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic - Main Campus Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Renal Associates Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Geisinger Clinic Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| University of Iowa Health Care Medical Center - Nephrology Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Clinical & Translational Science Unit (CTSU) - Nephrology Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| DaVita Kidney Care - Las Vegas Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Kaiser Permanente Los Angeles Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Nephrology & Hypertension Associates, PC Coordinator of this site? Confirm its status | Middlebury | United States | Unknown status |
| University of Minnesota -Clinics and Surgery Center (CSC) - Endocrine Clinic Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Nephrology Clinical Trials Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University - Yale Nephrology Clinical Research Clinic Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| The Rogosin Kidney Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| General Nephrology Clinic - New York City Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Perelman Center for Advanced Medicine - Nephrology Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| UCSF Clinical Research Center at Parnassus Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Swedish Center for Comprehensive Care Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
Related publications
- Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease.Kidney360 · 2026 · PMID 41385299
This page is information, not medical advice. Discuss any trial with your doctor.