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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)


Outcome Timeframe From Baseline at Week 48

NCTID NCT05312879

Phases PHASE2,PHASE3

Primary Purpose TREATMENT

Start Date 2022-03-30

Completion Date 2026-05

Enrollment Target 466

Interventions

DRUG VX-147

DRUG Placebo

Locations Recruiting

Alabama Kidney Research

United States, Alabama, Alabaster


Cardiology, P.C.

United States, Alabama, Birmingham


Nephrology Associates

United States, Alabama, Fairhope


Nephrology Consultants, LLC

United States, Alabama, Huntsville


Renal Associates of Alabama, LLC

United States, Alabama, Montgomery


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