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Recruiting Phase 2 NCT07268638

A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)

Phase 2 – studying effectiveness and dosage
Conditions: Focal Segmental Glomerulosclerosis

Sponsor: Akebia Therapeutics

trial.available_in: БГ
Overview
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.
Who can participate
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)
Interventions
Praliciguat
DRUG
Placebo
OTHER
Locations 10
United States (10)
Investigator Site #5
Arlington , Texas
Investigator Site #4
Chattanooga , Tennessee
Investigator Site #3
Chicago , Illinois
Investigator Site #2
Chula Vista , California
Investigator Site #6
Coral Springs , Florida
Investigator Site #9
Dallas , Texas
Investigator Site # 1
Lawrenceville , Georgia
Investigator Site #7
Miami , Florida
Investigator Site #8
Orlando , Florida
Investigator Site #10
Pontiac , Michigan
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.12.2025
Completion date
01.01.2028
Registry ID
NCT07268638
Source
clinicaltrials.gov
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