Actively Recruiting
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Led by Akebia Therapeutics · Updated on 2026-04-23
60
Participants Needed
10
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Urine protein-to-creatinine ratio (UPCR) of 1 g/g or higher during screening
- Taking maximally tolerated ACE inhibitor (ACEi) or angiotensin receptor blocker (ARB) within 1 month before consent
- Estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73 m² or higher by CKD-EPI equation
- Kidney biopsy within 3 years showing FSGS or genetic mutation in podocyte protein linked to FSGS
You will not qualify if you...
- Collapsing form of FSGS seen in kidney biopsy
- Having sickle cell disease
- HbA1c greater than 8% or non-fasting blood glucose over 180 mg/dL
- Uncontrolled high blood pressure (160/100 mm Hg or higher)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Investigator Site #2
Chula Vista, California, United States, 91910
Actively Recruiting
2
Investigator Site #6
Coral Springs, Florida, United States, 33071
Actively Recruiting
3
Investigator Site #7
Miami, Florida, United States, 33172
Actively Recruiting
4
Investigator Site #8
Orlando, Florida, United States, 32806
Actively Recruiting
5
Investigator Site # 1
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
6
Investigator Site #3
Chicago, Illinois, United States, 60643
Actively Recruiting
7
Investigator Site #10
Pontiac, Michigan, United States, 48341
Actively Recruiting
8
Investigator Site #4
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
9
Investigator Site #5
Arlington, Texas, United States, 76015
Actively Recruiting
10
Investigator Site #9
Dallas, Texas, United States, 75231
Actively Recruiting
Research Team
A
Akebia Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here