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Recruiting Phase 2 NCT07161037

Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)

Trial Parameters

Condition Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Sponsor Vertex Pharmaceuticals Incorporated
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 24
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-11-19
Completion 2027-07-22
Interventions
VX-407

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

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.

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