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VX-407 for adults with ADPKD who have specific 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

Phase 2 Interventional Vertex Pharmaceuticals Incorporated · NCT07161037

This trial will test whether VX-407 can slow kidney growth and is safe and tolerable in adults with ADPKD who have certain PKD1 gene variants.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment24 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorVertex Pharmaceuticals Incorporated Industry-sponsored
Locations42 sites (Alabaster, Alabama and 41 other locations)
Trial IDNCT07161037 on ClinicalTrials.gov

What this trial studies

AGLOW is a Phase 2a interventional study giving VX-407 to participants with ADPKD who carry a subset of PKD1 gene variants. Eligible participants must have Mayo imaging class 1B–1E with htTKV confirmed by screening MRI and an eGFR ≥25 mL/min/1.73 m2. The main outcome is change in height-adjusted total kidney volume (htTKV); safety, tolerability, and pharmacokinetics of VX-407 will also be monitored. Study visits include regular clinic assessments, MRI scans, laboratory testing, and PK sampling at U.S. sites.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of ADPKD who have the specified PKD1 gene variants, Mayo imaging class 1B–1E with htTKV ≥250 mL/m, an eGFR ≥25 mL/min/1.73 m2, and the ability to attend study visits are the intended participants.

Not a fit: Patients with very advanced kidney disease (eGFR <25 mL/min/1.73 m2), those on or planning to start renal replacement therapy within 12 months, prior transplant or nephrectomy, or other non-ADPKD kidney diseases are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, VX-407 could slow kidney growth in ADPKD patients and help delay decline in kidney function.

How similar studies have performed: Previous ADPKD trials (for example with vasopressin V2 receptor antagonists) have shown it is possible to slow TKV growth, but targeted agents for specific PKD1 variants like VX-407 are still early in testing.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Alabaster, Alabama and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Autosomal Dominant Polycystic Kidney Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.