Active, not yet recruiting
A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease
NCT No.: NCT05312879
Study Type: INTERVENTIONAL
Phase:
Phase II
Region: California - Northern
Acronym:
Official Title
A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease
Purpose
The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of VX-147 in participants aged 18 years and older with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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APOL1 genotype of G1/G1, G2/G2, or G1/G2;
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Proteinuric kidney disease;
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Exclusion Criteria
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Solid organ or bone marrow transplant;
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Uncontrolled hypertension;
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Diagnosis of diabetes mellitus;
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Known underlying cause of kidney disease including but not limited to sickle cell disease;
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Please contact study team, other protocol defined Inclusion/Exclusion criteria apply;
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Keywords and/or Specific Medical Conditions
Sponsors
- Vertex Pharmaceuticals Incorporated
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