Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW)
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
2 other identifiers
interventional
24
7 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2025
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2025
CompletedFirst Posted
Study publicly available on registry
September 8, 2025
CompletedStudy Start
First participant enrolled
November 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 24, 2026
November 1, 2025
1.7 years
August 29, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
htTKV on MRI Over Time
Baseline up to End of Study (Week 52)
Secondary Outcomes (3)
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day 1 up to Week 54
Maximum Observed Plasma Concentration (Cmax) of VX-407
From Day 1 up to Week 52
Area Under the Concentration Versus Time Curve (AUC) of VX-407
From Day 1 up to Week 52
Study Arms (1)
VX-407
EXPERIMENTALParticipants will receive VX-407 for up to 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Alabama Kidney Research
Alabaster, Alabama, 35007, United States
UAB Nephrology Research at CH19
Birmingham, Alabama, 35294, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
UCSF Clinical Research Center at Parnassus
San Francisco, California, 94143, United States
Nephrology & Hypertension Associates, PC
Middlebury, Connecticut, 06762, United States
Yale University - Yale Nephrology Clinical Research Clinic
New Haven, Connecticut, 06510, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Emory School of Medicine - Renal Division
Atlanta, Georgia, 30322, United States
Renal Associates
Columbus, Georgia, 31904, United States
UChicago Medicine - Duchossois Center for Advanced Medicine - Nephrology
Chicago, Illinois, 60637, United States
University of Iowa Health Care Medical Center- Nephrology
Iowa City, Iowa, 52242, United States
Clinical & Translational Science Unit (CTSU) - Nephrology
Kansas City, Kansas, 66160, United States
University of Maryland Medical Center - General Clinical Research Center
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center - Nephrology
Boston, Massachusetts, 02215, United States
University of Minnesota -Clinics and Surgery Center (CSC) - Endocrine Clinic
Minneapolis, Minnesota, 55455, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
DaVita Kidney Care - Las Vegas
Las Vegas, Nevada, 89107, United States
The Rogosin Kidney Center
New York, New York, 10021, United States
General Nephrology Clinic - New York City
New York, New York, 10032, United States
Cleveland Clinic - Main Campus
Cleveland, Ohio, 44195, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
Perelman Center for Advanced Medicine - Nephrology
Philadelphia, Pennsylvania, 19104, United States
UVM Medical Center - 1 South Prospect Street
Burlington, Vermont, 05401, United States
Swedish Center for Comprehensive Care
Seattle, Washington, 98104, United States
Universite Catholique de Louvain - Nephrology
Brussels, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Nephrology
Leuven, Belgium
McGill University Health Centre
Montreal, Canada
Centre Hospitalier Regional Universitaire (CHRU) Brest
Brest, France
Hopital Necker Enfants Malades - Neurology
Paris, France
Charité - Klinik für Nephrologie und Intensivmedizin der
Berlin, Germany
University Hospital Cologne (Koeln) - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
Cologne, Germany
Fundacio Puigvert
Barcelona, Spain
Hospital Fundacion Jimenez Diaz
Madrid, Spain
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
King's College Hospital - Pulmonology
London, United Kingdom
Royal Free Hospital - Nephrology
London, United Kingdom
St George's Hospital London - Nephrology
London, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital - Nephrology
Newcastle upon Tyne, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2025
First Posted
September 8, 2025
Study Start
November 19, 2025
Primary Completion (Estimated)
July 22, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 24, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/