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Active, Not Recruiting

NCT Number: NCT07161037

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universite Catholique de Louvain - Nephrology, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-407

Drug

Tablets for oral administration.

Primary outcomes

  1. htTKV on MRI Over Time

    Time frame: Baseline up to End of Study (Week 52)

Secondary outcomes

  1. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From Day 1 up to Week 54

  2. Maximum Observed Plasma Concentration (Cmax) of VX-407

    Time frame: From Day 1 up to Week 52

  3. Area Under the Concentration Versus Time Curve (AUC) of VX-407

    Time frame: From Day 1 up to Week 52

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Acronym: AGLOW

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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