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A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Sponsor: Akebia Therapeutics
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-12-03
Completion Date
2028-01
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Praliciguat
Oral Tablet
Placebo
Oral Tablet
Locations (8)
Investigator Site #2
Chula Vista, California, United States
Investigator Site #6
Coral Springs, Florida, United States
Investigator Site #7
Miami, Florida, United States
Investigator Site #8
Orlando, Florida, United States
Investigator Site # 1
Lawrenceville, Georgia, United States
Investigator Site #3
Chicago, Illinois, United States
Investigator Site #4
Chattanooga, Tennessee, United States
Investigator Site #5
Arlington, Texas, United States