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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Focal Segmental Glomerulosclerosis

In brief

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.

Key facts

Study ID

NCT07268638

Run by

Akebia Therapeutics

People needed

60

Starts

2025-12-03

Expected to finish

2028-01-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Collapsing FSGS in the kidney biopsy report.
• Sickle cell disease.
• HbA1c >8%.
• Uncontrolled hypertension (≥160/100 millimeters of mercury).

Where it is running

• Investigator Site #18 — Houston, Texas, United States (enrolling)
• Investigator Site #14 — Los Angeles, California, United States (enrolling)
• Investigator Site #12 — San Dimas, California, United States (enrolling)
• Investigator Site #13 — Arvada, Colorado, United States (enrolling)
• Investigator Site #17 — Boca Raton, Florida, United States (enrolling)
• Investigator Site #6 — Coral Springs, Florida, United States (enrolling)
• Investigator Site #7 — Miami, Florida, United States (enrolling)
• Investigator Site #8 — Orlando, Florida, United States (enrolling)
• Investigator Site # 1 — Lawrenceville, Georgia, United States (enrolling)
• Investigator Site #2 — Chula Vista, California, United States (enrolling)
• Investigator Site #11 — Louisville, Kentucky, United States (enrolling)
• Investigator Site #15 — Livonia, Michigan, United States (enrolling)
• Investigator Site #10 — Pontiac, Michigan, United States (enrolling)
• Investigator Site #16 — New Bern, North Carolina, United States (enrolling)
• Investigator Site #20 — Cleveland, Ohio, United States (enrolling)
• Investigator Site #19 — Bridgeville, Pennsylvania, United States (enrolling)
• Investigator Site #22 — Butler, Pennsylvania, United States (enrolling)
• Investigator Site #23 — Goose Creek, South Carolina, United States (enrolling)
• Investigator Site #4 — Chattanooga, Tennessee, United States (enrolling)
• Investigator Site #5 — Arlington, Texas, United States (enrolling)
• Investigator Site #21 — Dallas, Texas, United States (enrolling)
• Investigator Site #9 — Dallas, Texas, United States (enrolling)
• Investigator Site #3 — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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