Phase 2/3 Study of VX-147 for APOL1-Mediated Proteinuric Kidney Disease
This study is testing a drug called VX-147 in adults and children with a specific type of kidney disease called APOL1-mediated proteinuric kidney disease. This condition causes too much protein in your urine. Researchers want to see how well VX-147 works, if it's safe, and how your body handles it. You might be able to join if you are between 10 and 65 years old and have the specific APOL1 gene type and proteinuric kidney disease. The study will look at changes in protein in your urine and how your kidney function (eGFR) changes over time. The current status of this study is unclear, and it plans to enroll 466 participants.
- Study design
- This is an interventional study where participants will receive either VX-147 tablets or placebo tablets. It is designed to enroll 466 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your kidney function will be assessed from baseline through at least 2 years of study completion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease
At a glance
Conditions
Where it's being run
318 sites across 46 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Part A: Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)From Baseline to Week 48
- Part A: Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at Interim AnalysisFrom Baseline Through >= Week 48
- Part A: eGFR Slope Assessed at Final AnalysisFrom Baseline Through Study Completion (At least 2 years of eGFR data assessed at the final analysis)
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)Day 1 Through Study Completion (Approximately 4 Years After the Last Participant Enrolls)