Actively Recruiting
Adaptive Study of Oral VX-147 Tablets in Children and Adults Aged 10 to 65 With APOL1-Related Proteinuric Kidney Disease
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-08-04
466
Participants Needed
318
Research Sites
100 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.
CONDITIONS
Brief Title
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease
Research Team
M
Medical Information
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