Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease (AMPLITUDE)
Recruitment Status: Recruiting
Start Date: March 30, 2022
End Date: May 07, 2030
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.
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.
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.
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Conditions:
- Kidney Disease