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

Part of paid clinical trials in Chula Vista, California.

Sponsor
Akebia Therapeutics
Study ID
NCT07268638
Phase
PHASE2
Status
Recruiting
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Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Praliciguat — DRUG
    Oral Tablet
  • Placebo — OTHER
    Oral Tablet

Study Details

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.

Key Dates

Start date
Dec 3, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Praliciguat
    Praliciguat will be administered daily with dose escalation to a target dose during a 24-week double-blind period, followed by a 24-week open-label treatment period.
  • Placebo Comparator: Placebo
    Matching placebo will be administered daily for 24 weeks

Primary Outcome Measure

Change from Baseline in urine protein-to-creatinine ratio (UPCR) [ Time Frame: Baseline (Day 1) and up to Week 24 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Investigator Site #2Chula VistaCalifornia91910-
Investigator Site #14Los AngelesCalifornia90022-
Investigator Site #12San DimasCalifornia91773-
Investigator Site #13ArvadaColorado80002-
Investigator Site #6Coral SpringsFlorida33071-
Investigator Site #7MiamiFlorida33172-
Investigator Site #8OrlandoFlorida32806-
Investigator Site # 1LawrencevilleGeorgia30046-
Investigator Site #3ChicagoIllinois60643-
Investigator Site #11LouisvilleKentucky40205-
Investigator Site #10PontiacMichigan48341-
Investigator Site #4ChattanoogaTennessee37404-
Investigator Site #5ArlingtonTexas76015-
Investigator Site #9DallasTexas75231-

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