This study is in progress, not accepting new patients

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

a study on Autosomal Dominant Polycystic Kidney Disease Kidney Disease

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Meyeon Park (ucsf)
Headshot of Meyeon Park
Meyeon Park

Description

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.

Official 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

Keywords

Autosomal Dominant Polycystic Kidney Disease (ADPKD), Autosomal Dominant Polycystic Kidney

Eligibility

You can join if…

Open to people ages 18-65

  • 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 (m2)

You CAN'T join 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

Other protocol defined Inclusion/Exclusion criteria will apply.

Locations

  • UCSF Clinical Research Center at Parnassus
    San Francisco California 94143 United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles California 90027 United States

Lead Scientist at University of California Health

  • Meyeon Park (ucsf)
    My research focuses on patient outcomes in genetic kidney diseases including polycystic kidney disease and APOL1-mediated kidney disease. I am the medical director of the UCSF PKD Center of Excellence and principal investigator of the UCSF Cardiovascular Risk After Kidney Transplantation (CARAKTER) study.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vertex Pharmaceuticals Incorporated
ID
NCT07161037
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 26 people participating
Last Updated