Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW) (NCT07161037) | Clinical Trial Compass
RecruitingPhase 2
Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
United States24 participantsStarted 2025-11-19
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.