Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease

Conditions

• Proteinuric Kidney Disease

Eligibility Criteria

Sex

ALL

Age

10 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• VX-147 — DRUG
  Tablets for oral administration.
• Placebo — DRUG
  Tablets for oral administration.

Study Details

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.

Key Dates

Start date

Mar 30, 2022

Status verified

Apr 2026

Primary completion

Jun 2, 2028

Completion

May 7, 2030

Study Design

Enrollment

466 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A (Phase 2/3): VX-147
  Participants will be randomized to receive different doses of VX-147. Participants will receive the selected dose of VX-147 for atleast 96 weeks.
• Placebo Comparator: Part A (Phase 2/3): Placebo
  Participants will receive placebo matched to VX-147.
• Experimental: Part B (Phase 3): VX-147
  Participants who complete Part A will receive VX-147 for an additional 96 weeks.

Primary Outcome Measure

Part A: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis) [ Time Frame: From Baseline to Week 48 ]

Central Contacts

• Medical Information
  617-341-6777
  [email protected]

Locations (227)

Find similar trials in Alabaster, AL

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