A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Recruiting · NCT07268638 · Interventional (participants receive a specific treatment) · Lead sponsor: Akebia Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboPraliciguat
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS.
Exclusion criteria
- Collapsing FSGS in the kidney biopsy report.
- Sickle cell disease.
- HbA1c \>8%.
- Uncontrolled hypertension (≥160/100 millimeters of mercury).
Where it is running
25 locations listed across 14 US states.
- Investigator Site #2 - Chula Vista, California, United States
- Investigator Site #14 - Los Angeles, California, United States
- Investigator Site #12 - San Dimas, California, United States
- Investigator Site #13 - Arvada, Colorado, United States
- Investigator Site #17 - Boca Raton, Florida, United States
- Investigator Site #6 - Coral Springs, Florida, United States
- Investigator Site #25 - Hialeah, 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 #11 - Louisville, Kentucky, United States
- Investigator Site #24 - Worcester, Massachusetts, United States
- Investigator Site #15 - Livonia, Michigan, United States
- Investigator Site #10 - Pontiac, Michigan, United States
- Investigator Site #16 - New Bern, North Carolina, United States
- Investigator Site #20 - Cleveland, Ohio, United States
- Investigator Site #19 - Bridgeville, Pennsylvania, United States
- Investigator Site #22 - Butler, Pennsylvania, United States
- Investigator Site #23 - Goose Creek, South Carolina, United States
- Investigator Site #4 - Chattanooga, Tennessee, United States
- Investigator Site #5 - Arlington, Texas, United States
- Investigator Site #21 - Dallas, Texas, United States
- Investigator Site #9 - Dallas, Texas, United States
- Investigator Site #18 - Houston, Texas, United States