Study Summary
This trial will study if VX-147 is an effective, safe, and tolerable treatment for adults with APOL1-mediated kidney disease. The drug's PK will also be analyzed.
Eligible Conditions
- Proteinuric Kidney Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 5 Secondary · Reporting Duration: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
Year 2
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Week 12
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147
Maximum Observed Plasma Concentration (Cmax) of VX-147
Week 48
Observed Pre-dose Plasma Concentration (Ctrough) of VX-147
Week 48
Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis
Year 2
Time to Composite Clinical Outcome of a Sustained Decline of >=30 Percent (%) in eGFR, the Onset of end-stage Kidney Disease or Death
eGFR Slope Assessed at Study Completion
Week 48
Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Phase 2: VX-147
1 of 4
Phase 3: VX-147
1 of 4
Phase 2: Placebo
1 of 4
Phase 3: Placebo
1 of 4
Experimental Treatment
Non-Treatment Group
466 Total Participants · 4 Treatment Groups
Primary Treatment: VX-147 · Has Placebo Group · Phase 2 & 3
Phase 2: VX-147
Drug
Experimental Group · 1 Intervention: VX-147 · Intervention Types: DrugPhase 3: VX-147
Drug
Experimental Group · 1 Intervention: VX-147 · Intervention Types: DrugPhase 2: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugPhase 3: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-147
2020
Completed Phase 2
~20
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline through study completion (approximately 2 years after the last participant enrolls)
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
221 Previous Clinical Trials
30,104 Total Patients Enrolled
Eligibility Criteria
Age 18 - 60 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have proteinuria.
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Conditions
Cancer Related
Treatments