Actively Recruiting
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
Led by Akebia Therapeutics · Updated on 2026-06-05
60
Participants Needed
14
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of praliciguat in adults diagnosed with focal segmental glomerulosclerosis (FSGS), confirmed through kidney biopsy. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to evaluate how well praliciguat works and its safety in this patient group. The trial is sponsored by Akebia Therapeutics and focuses on reducing protein levels in urine, a key marker of kidney damage in FSGS. Participants will be randomly assigned to one of two groups for the first 24 weeks: one group will receive praliciguat, starting with dose escalation to reach a target dose, and the other will receive a matching placebo, both taken daily as oral tablets. After this double-blind period, all participants will continue receiving praliciguat openly for an additional 24 weeks, allowing for extended observation of treatment effects. During the study, participants will have their urine protein-to-creatinine ratio (UPCR) measured from baseline through week 24 as the main outcome. Additional assessments include monitoring the percentage of participants achieving partial remission by week 24. The study involves close monitoring for safety and effectiveness, with scheduled visits and evaluations over a total of 48 weeks, including both the blinded and open-label treatment phases.
CONDITIONS
Brief 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
- On maximally tolerated ACE inhibitor or angiotensin receptor blocker (ARB) within 1 month before consent
- Estimated glomerular filtration rate (eGFR) of 25 milliliters per minute per 1.73 square meters or higher
- Kidney biopsy within 3 years confirming FSGS or documented genetic mutation in a podocyte protein linked to FSGS
You will not qualify if you...
- Collapsing FSGS found in kidney biopsy report
- History of sickle cell disease
- HbA1c above 8% or non-fasting blood glucose above 180 mg/dL
- Uncontrolled high blood pressure of 160/100 mm Hg or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive praliciguat or placebo daily with dose escalation to a target dose during a 24-week double-blind period followed by a 24-week open-label treatment period.
Visits occur periodically during the 48-week treatment period
Trial Site Locations
Total: 14 locations
1
Investigator Site #2
Chula Vista, California, United States, 91910
Actively Recruiting
2
Investigator Site #14
Los Angeles, California, United States, 90022
Actively Recruiting
3
Investigator Site #12
San Dimas, California, United States, 91773
Actively Recruiting
4
Investigator Site #13
Arvada, Colorado, United States, 80002
Actively Recruiting
5
Investigator Site #6
Coral Springs, Florida, United States, 33071
Actively Recruiting
6
Investigator Site #7
Miami, Florida, United States, 33172
Actively Recruiting
7
Investigator Site #8
Orlando, Florida, United States, 32806
Actively Recruiting
8
Investigator Site # 1
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
9
Investigator Site #3
Chicago, Illinois, United States, 60643
Terminated
10
Investigator Site #11
Louisville, Kentucky, United States, 40205
Actively Recruiting
11
Investigator Site #10
Pontiac, Michigan, United States, 48341
Actively Recruiting
12
Investigator Site #4
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
13
Investigator Site #5
Arlington, Texas, United States, 76015
Actively Recruiting
14
Investigator Site #9
Dallas, Texas, United States, 75231
Actively Recruiting
Research Team
A
Akebia Therapeutics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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