Status:
RECRUITING
Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07161037
Start Date
November 19 2025
End Date
December 31 2027
Last Update
December 18 2025
Active Locations (21)
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1
Alabama Kidney Research
Alabaster, Alabama, United States, 35007
2
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
3
UCSF Clinical Research Center at Parnassus
San Francisco, California, United States, 94143
4
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut, United States, 06762