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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
466
Percent Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 (Assessed at the Week 48 Interim Analysis)
Time frame: From Baseline at Week 48
Estimated Glomerular Filtration Rate (eGFR) Slope Assessed at the Week 48 Interim Analysis
Time frame: From Baseline Through >= Week 48
eGFR Slope Assessed at Study Completion
Time frame: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
Time to Composite Clinical Outcome of a Sustained Decline of >=30 Percent (%) in eGFR, the Onset of end-stage Kidney Disease or Death
Time frame: From Baseline Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 Through Study Completion (Approximately 2 Years After the Last Participant Enrolls)
Maximum Plasma Concentration (Cmax) of VX-147
Time frame: Day 1 and Week 40
Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-147
Time frame: Day 1 and Week 40
Observed Pre-dose Plasma Concentration (Ctrough) of VX-147
Time frame: Day 1 up to Week 40
Acceptability Tablet Formulation of VX-147 in Pediatric Participants using the Convenience Domain of the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
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Alabama Kidney Research
Alabaster, Alabama, United States
RECRUITINGEmVenio Research - Mobile Unit - Birmingham
Birmingham, Alabama, United States
RECRUITINGCardiology, P.C.
Birmingham, Alabama, United States
COMPLETEDChildren's Hospital of Alabama
Birmingham, Alabama, United States
RECRUITINGThe Kirklin Clinic - Nephrology
Birmingham, Alabama, United States
RECRUITINGNephrology Associates
Fairhope, Alabama, United States
RECRUITINGHeart Center Research LLC
Huntsville, Alabama, United States
RECRUITINGNephrology Consultants, LLC
Huntsville, Alabama, United States
RECRUITINGRenal Associates of Alabama, LLC
Montgomery, Alabama, United States
RECRUITINGArizona Kidney Disease and Hypertension Center - Banner Desert Office
Mesa, Arizona, United States
WITHDRAWN...and 308 more locations
Time frame: Day 1 and Week 48