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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• UPCR ≥1 (g/g) during screening.
• On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.
• Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• Kidney biopsy within 3 years of screening consistent with FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.
Locations
United States
California
Investigator Site #2
RECRUITING
Chula Vista
Investigator Site #14
RECRUITING
Los Angeles
Investigator Site #12
RECRUITING
San Dimas
Colorado
Investigator Site #13
RECRUITING
Arvada
Florida
Investigator Site #6
RECRUITING
Coral Springs
Investigator Site #7
RECRUITING
Miami
Investigator Site #8
RECRUITING
Orlando
Georgia
Investigator Site # 1
RECRUITING
Lawrenceville
Illinois
Investigator Site #3
TERMINATED
Chicago
Kentucky
Investigator Site #11
RECRUITING
Louisville
Michigan
Investigator Site #10
RECRUITING
Pontiac
Tennessee
Investigator Site #4
RECRUITING
Chattanooga
Texas
Investigator Site #5
RECRUITING
Arlington
Investigator Site #9
RECRUITING
Dallas
Contact Information
Primary
Akebia Therapeutics
trials@akebia.com
16178446128
Time Frame
Start Date:2025-12-03
Estimated Completion Date:2028-01
Participants
Target number of participants:60
Treatments
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