This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in participants with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis (FSGS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Tablets for oral administration.
Percent Change From Baseline in UPCR
Time frame: From Baseline up to Week 13
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline up to Week 17
Maximum Observed Concentration (Cmax) of VX-147
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, and 12 hours post-dose on Day 1 and Week 5
Observed Pre-dose Concentration (Ctrough) of VX-147
Time frame: Pre-dose on Day 8, 15, Week 3, 5, 9 and 13
Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24hr) of VX-147
Time frame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 12 and 24 hours Post-dose on Week 5
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham - The Kirklin Clinic
Birmingham, Alabama, United States
California Institute of Renal Research
San Diego, California, United States
The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension
Washington D.C., District of Columbia, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Kidney and Hypertension Specialists of Miami
Miami, Florida, United States
Florida Premier Research Institute
Winter Park, Florida, United States
Morehouse School of Medicine, Grady Memorial Hospital
Atlanta, Georgia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Georgia Nehphrology
Lawrenceville, Georgia, United States
Central Georgia Kidney Specialists PC
Macon, Georgia, United States
...and 34 more locations