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

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.

CT.gov Identifier
NCT07268638
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Akebia Therapeutics
Collaborator
N/A
Study Contact Information
+1 617-871-2098
Recruiting
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Study Details

Diseases
Focal Segmental Glomerulosclerosis
Study Drug
Praliciguat
See More
Angiotensin receptor blockers
Undisclosed - ACE inhibitor
Genes
N/A
Study Dates
Dec 2025 - Jun 2027
Sex
Female & Male
Age
18+ years
Inclusion and Exclusion Criteria
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)

Protocol 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.

Study Locations

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