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