Clinical Trials in Spain / NCT07161037
Active, not recruiting
Phase 2
Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
NCT07161037 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study 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
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.
Primary outcome measure(s)
- htTKV on MRI Over Time — Baseline up to End of Study (Week 52)
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Kidney Research | Alabaster | Alabama | |
| UAB Nephrology Research at CH19 | Birmingham | Alabama | |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | |
| UCSF Clinical Research Center at Parnassus | San Francisco | California | |
| Nephrology & Hypertension Associates, PC | Middlebury | Connecticut | |
| Yale University - Yale Nephrology Clinical Research Clinic | New Haven | Connecticut | |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | |
| Emory School of Medicine - Renal Division | Atlanta | Georgia | |
| Renal Associates | Columbus | Georgia | |
| UChicago Medicine - Duchossois Center for Advanced Medicine - Nephrology | Chicago | Illinois | |
| University of Iowa Health Care Medical Center- Nephrology | Iowa City | Iowa | |
| Clinical & Translational Science Unit (CTSU) - Nephrology | Kansas City | Kansas | |
| University of Maryland Medical Center - General Clinical Research Center | Baltimore | Maryland | |
| Tufts Medical Center | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center - Nephrology | Boston | Massachusetts | |
| University of Minnesota -Clinics and Surgery Center (CSC) - Endocrine Clinic | Minneapolis | Minnesota | |
| Mayo Clinic - Rochester | Rochester | Minnesota | |
| DaVita Kidney Care - Las Vegas | Las Vegas | Nevada | |
| The Rogosin Kidney Center | New York | New York | |
| General Nephrology Clinic - New York City | New York | New York | |
| Cleveland Clinic - Main Campus | Cleveland | Ohio | |
| Geisinger Clinic | Danville | Pennsylvania | |
| Perelman Center for Advanced Medicine - Nephrology | Philadelphia | Pennsylvania | |
| Nephrology Clinical Trials Center | Nashville | Tennessee | |
| UVM Medical Center - 1 South Prospect Street | Burlington | Vermont | |
| Swedish Center for Comprehensive Care | Seattle | Washington | |
| 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 | |
| Hopital Bretonneau | Tours | France | |
| Charité - Klinik für Nephrologie und Intensivmedizin der | Berlin | Germany | |
| University Hospital Cologne (Koeln) - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin | Cologne | Germany | |
| UMCG - Nephrology | Groningen | Netherlands | |
| 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 |
+ 3 more sites — see the full list on the official registry below.
More Vertex Pharmaceuticals Incorporated trials in Spain
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07161037 on ClinicalTrials.gov ↗ ← All trials in Spain