A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Phase 2 – studying effectiveness and dosage
Conditions:
Focal Segmental Glomerulosclerosis
Sponsor: Akebia Therapeutics
trial.available_in:
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Overview
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.
Who can participate
Inclusion Criteria:
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 within 3 years of screening consistent with FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.
Exclusion Criteria:
1. Collapsing FSGS in the kidney biopsy report.
2. Sickle cell disease.
3. HbA1c \>8% or non-fasting blood glucose \>180 milligram/decilitre.
4. Uncontrolled hypertension (≥160/100 millimeters of mercury)