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

NCT ID: NCT07161037

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-19

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VX-407

Participants will receive VX-407 for up to 52 weeks.

Group Type EXPERIMENTAL

VX-407

Intervention Type DRUG

Tablets for oral administration.

Interventions

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VX-407

Tablets for oral administration.

Intervention Type DRUG

Eligibility Criteria

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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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alabama Kidney Research

Alabaster, Alabama, United States

Site Status RECRUITING

University of Alabama at Birmingham- Nephrology Research Clinic

Birmingham, Alabama, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

UCSF Clinical Research Center at Parnassus

San Francisco, California, United States

Site Status RECRUITING

Nephrology & Hypertension Associates, PC

Middlebury, Connecticut, United States

Site Status RECRUITING

Yale University - Yale Nephrology Clinical Research Clinic

New Haven, Connecticut, United States

Site Status RECRUITING

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

Emory School of Medicine - Renal Division

Atlanta, Georgia, United States

Site Status RECRUITING

Renal Associates

Columbus, Georgia, United States

Site Status RECRUITING

UChicago Medicine - Duchossois Center for Advanced Medicine - Nephrology

Chicago, Illinois, United States

Site Status RECRUITING

University of Iowa Health Care Medical Center- Nephrology

Iowa City, Iowa, United States

Site Status RECRUITING

The University of Kansas Medical Center Division of Nephrology

Kansas City, Kansas, United States

Site Status RECRUITING

University of Maryland Medical Center - General Clinical Research Center

Baltimore, Maryland, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

University of Minnesota -Clinics and Surgery Center (CSC) - Endocrine Clinic

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

DaVita Kidney Care - Las Vegas

Las Vegas, Nevada, United States

Site Status RECRUITING

Columbia University Medical Center/NYP

New York, New York, United States

Site Status NOT_YET_RECRUITING

UVM Medical Center - 1 South Prospect Street

Burlington, Vermont, United States

Site Status RECRUITING

Universite Catholique de Louvain - Nephrology

Brussels, , Belgium

Site Status RECRUITING

McGill University Health Centre

Montreal, , Canada

Site Status RECRUITING

Centre Hospitalier Regional Universitaire (CHRU) Brest

Brest, , France

Site Status RECRUITING

Queen Elizabeth Hospital Birmingham

Birmingham, , United Kingdom

Site Status RECRUITING

King's College Hospital - Pulmonology

London, , United Kingdom

Site Status RECRUITING

Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital - Nephrology

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Countries

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United States Belgium Canada France United Kingdom

Central Contacts

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Medical Information

Role: CONTACT

617-341-6777

Other Identifiers

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2024-517393-13-00

Identifier Type: OTHER

Identifier Source: secondary_id

VX24-407-101

Identifier Type: -

Identifier Source: org_study_id

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