A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Aged 18 Years and Older With APOL1-mediated Proteinuric Kidney Disease
This is a study of the prevalence of APOL1 alleles in adults who are of recent African ancestry or geographic origin. The study will enroll up to a total of approximately 2500 subjects into 2 groups. Group 1 includes subjects with FSGS, and Group 2 includes subjects with other forms of proteinuric nondiabetic CKD. No study drug will be administered.
The purpose of this Phase II trial is to see if R3R01 is safe in patients with Alport Syndrome and Focal Segmental Glomerulosclerosis. This will be done by evaluating how efficient R3R01 is in decreasing proteinuria levels.
The study will consist of a screening period, a treatment period, and a follow-up period. If you qualify, you will receive the study drug R3R01 for 12 weeks. We will then follow up with you after for an additional 12 weeks.
This is a phase 2, randomized, double-blind, placebo-controlled, crossover study to evaluate the safety and efficacy of atrasentan vs placebo while on background therapy with SGLT2i in subjects with IgAN. The primary efficacy assessment is the change from baseline in proteinuria (UPCR) at week 12. Eligible subjects who are enrolled in the study will be randomly assigned in a 1 to 1 ratio to either sequence AB or sequence BA.
