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Recruiting NCT05312879

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

Conditions: Proteinuric Kidney Disease

Sex: All
Ages: 10 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 466
Sponsor: Vertex Pharmaceuticals Incorporated

Location: Alabama Kidney Research Alabaster Alabama

Summary

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.

Eligibility Criteria

Key Inclusion Criteria: Part A: * APOL1 genotype of G1/G1, G2/G2, or G1/G2 * Proteinuric kidney disease Part B: \- Completion of Treatment Period in Part A and no permanent discontinuation of study drug. Key Exclusion Criteria: Part A: * 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 Part B: * ESKD (End Stage Kidney Disease) as defined in the protocol. * Any lab abnormality that may pose a safety risk to the participant, as judged by the investigator. Other protocol defined Inclusion/Exclusion criteria will apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05312879). StuddyBuddy aggregates publicly available trial information.