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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria (Part A): 1. UPCR ≥1 (g/g) during screening. 2. On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent. 3. Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. 4. Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS. Exclusion Criteria (Part A): 1. Collapsing FSGS in the kidney biopsy report. 2. Sickle cell disease. 3. HbA1c \>8%. 4. Uncontrolled hypertension (≥160/100 millimeters of mercury). Inclusion Criteria (Part B): 1\. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.
About the study
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.
What is being tested
- Praliciguat (Part A) (drug)
- Placebo (Part A) (other)
- Praliciguat (Part B) (drug)
Sponsor: Akebia Therapeutics · Participants: 60 · Started: Dec 3, 2025
Contact the study team
- Akebia Therapeutics · Phone: 16178446128
Official record on ClinicalTrials.gov — NCT07268638
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.