Phase 2Recruiting
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Praliciguat in Patients With Biopsy-Confirmed Focal Segmental Glomerulosclerosis
- Sponsor
- Akebia Therapeutics (Industry)
- Enrolment
- 60 planned
- Conditions
- Focal Segmental Glomerulosclerosis
- Interventions
- Praliciguat (Part A); Placebo (Part A); Praliciguat (Part B)
- Ages
- adults, older adults
- Registry
- NCT07268638
Full record on ClinicalTrials.gov
From the registry
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). Participants will be randomized 1:1 to receive praliciguat or placebo for initial 24 week treatment period. Following this double-blind period, all participants will receive praliciguat in an open-label period for an additional 24 weeks. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.
Primary outcomes
- Change from Baseline in urine protein-to-creatinine ratio (UPCR) (Part A)
- Proportion of participants with TEAEs, serious adverse events (SAEs), and treatment-emergent adverse events of special interest (AESIs). (Part A)
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started