Actively Recruiting
Phase 2 Study of Praliciguat for Adults with Biopsy-Confirmed Focal Segmental Glomerulosclerosis FSGS Evaluating Safety and Effectiveness
Led by Akebia Therapeutics · Updated on 2026-07-13
60
Participants Needed
23
Research Sites
30 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the effects and safety of praliciguat in adults diagnosed with biopsy-confirmed focal segmental glomerulosclerosis FSGS. This kidney condition is being studied to understand how praliciguat impacts protein levels in urine and other health measures compared to placebo. The study is sponsored by Akebia Therapeutics and involves multiple centers. Participants will be randomly assigned to receive either praliciguat or a matching placebo daily during a 24-week double-blind period. The praliciguat dose will be gradually increased to a target level. After this period, all participants will continue with an open-label phase where everyone receives praliciguat daily for another 24 weeks. Throughout the study, participants will have their urine protein-to-creatinine ratio UPCR measured from baseline through Week 24 to assess treatment effects. Additional evaluations include monitoring partial remission rates at Week 24 and measuring plasma praliciguat levels at Weeks 24, 32, and 36. The total participation lasts up to 48 weeks, with safety and efficacy assessments occurring regularly during and after the treatment periods.
CONDITIONS
Brief Title
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Research Team
A
Akebia Therapeutics
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