A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Trial sites expanded: 25 → 30 locations
    • Interventions modified
    • Trial arms changed: 2 → 3
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: 2 to 3
  2. Study sites: 23 to 25v8
  3. Trial sites expanded: 14 → 23 locations
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 1 to 2
    v7
  4. Trial sites expanded: 10 → 14 locationsv6
  5. Study sites: 8 to 10v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 5 to 8v4
  2. Study sites: 1 to 5v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2025 to Dec 3, 2025
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07268638
Lead Sponsor Akebia Therapeutics
Conditions
(from sponsor)		 Focal Segmental Glomerulosclerosis
Related terms Glomerulosclerosis, Focal Segmental, Proteinuria, Renal Insufficiency, Chronic
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov