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

RecruitingPhase 2, Phase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Conditions: Proteinuric Kidney Disease

Interventions: VX-147, Placebo

Countries: United States, Belgium, Brazil, Canada, Colombia, France, Ghana, Netherlands

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 overview

Sex: ALL

Age: 10 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (318)

Alabaster, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Fairhope, Alabama, United States
Huntsville, Alabama, United States
Huntsville, Alabama, United States
Montgomery, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Fresno, California, United States
Granada Hills, California, United States
Granada Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Sacramento, California, United States
San Francisco, California, United States
Torrance, California, United States
Victorville, California, United States
Bloomfield, Connecticut, United States
Middlebury, Connecticut, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
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