Trials / Recruiting
RecruitingNCT07268638
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Akebia Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 extension for an additional 24 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Praliciguat | Oral Tablet |
| OTHER | Placebo | Oral Tablet |
Timeline
- Start date
- 2025-12-03
- Primary completion
- 2027-06-01
- Completion
- 2028-01-01
- First posted
- 2025-12-08
- Last updated
- 2026-03-18
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07268638. Inclusion in this directory is not an endorsement.