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

ID#: NCT05312879

Age: 10 - 65 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2/Phase 3

Recruitment Status: Recruiting

Start Date: March 30, 2022

End Date: June 30, 2026

Contact Information:
Medical Information
617-341-6777
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: 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.
Find a Clinical Trial Find Cancer Clinical Trials