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

NCT07161037

Active Not RecruitingPhase 2

Sponsor: Vertex Pharmaceuticals Incorporated

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions: VX-407

Countries: United States, Belgium, Canada, France, Germany, Netherlands, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (43)
  • Alabaster, Alabama, United States
  • Birmingham, Alabama, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Middlebury, Connecticut, United States
  • New Haven, Connecticut, United States
  • Jacksonville, Florida, United States
  • Atlanta, Georgia, United States
  • Columbus, Georgia, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • Rochester, Minnesota, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Danville, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Burlington, Vermont, United States
  • Seattle, Washington, United States
  • Brussels, Belgium
  • Leuven, Belgium
  • Montreal, Canada
  • Brest, France
  • + 13 more on CT.gov