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A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects With APOL1-mediated Proteinuric Kidney Disease
Description
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
Trial Eligibility
Key Inclusion Criteria: * APOL1 genotype of G1/G1, G2/G2, or G1/G2 * Proteinuric kidney disease Key Exclusion Criteria: * Solid organ or bone marrow transplant * Uncontrolled hypertension * History of diabetes mellitus * Known underlying cause of kidney disease including but not limited to sickle cell disease Other protocol defined Inclusion/Exclusion criteria apply.
Study Info
Organization
Vertex Pharmaceuticals Incorporated
Primary Outcome
Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)
Interventions
Locations Recruiting
Alabama Kidney Research
United States, Alabama, Alabaster
EmVenio Research
United States, Alabama, Birmingham
Cardiology, P.C.
United States, Alabama, Birmingham
Nephrology Associates
United States, Alabama, Fairhope
Nephrology Consultants, LLC
United States, Alabama, Huntsville
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