Praliciguat treatment for adults with focal segmental glomerulosclerosis (FSGS)

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

This will test if praliciguat lowers urine protein in adults with biopsy-confirmed FSGS.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Akebia Therapeutics (Industry-sponsored)
• Locations: 10 sites (Chula Vista, California and 9 other locations)
• Trial ID: NCT07268638 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, double-blind, placebo-controlled multicenter study will assign adults with biopsy-confirmed FSGS 1:1 to receive praliciguat or placebo for a 24-week blinded period. Eligible participants must have UPCR ≥1 g/g, eGFR ≥25 mL/min/1.73 m2, and be on maximally tolerated ACEi or ARB therapy. After 24 weeks, all participants enter a 24-week open-label extension where everyone receives praliciguat. Key exclusions include collapsing FSGS, sickle cell disease, poor glycemic control (HbA1c >8% or non-fasting glucose >180 mg/dL), and uncontrolled hypertension.

Who should consider this trial

Good fit: Adults with biopsy-confirmed FSGS (or a pathogenic podocyte mutation), urine protein-to-creatinine ratio ≥1 g/g, eGFR ≥25 mL/min/1.73 m2, and on maximally tolerated ACEi or ARB are the intended participants.

Not a fit: People with collapsing FSGS, sickle cell disease, poorly controlled diabetes, uncontrolled hypertension, or very low kidney function are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, praliciguat could reduce proteinuria and help slow kidney damage in people with FSGS.

How similar studies have performed: Soluble guanylate cyclase stimulators like praliciguat have been studied in other cardiorenal conditions with mixed early results, and praliciguat has limited prior data specifically in FSGS.

Eligibility criteria

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)

Where this trial is running

Chula Vista, California and 9 other locations

• Investigator Site #2 — Chula Vista, California, United States (Recruiting)
• Investigator Site #6 — Coral Springs, Florida, United States (Recruiting)
• Investigator Site #7 — Miami, Florida, United States (Recruiting)
• Investigator Site #8 — Orlando, Florida, United States (Recruiting)
• Investigator Site # 1 — Lawrenceville, Georgia, United States (Recruiting)
• Investigator Site #3 — Chicago, Illinois, United States (Recruiting)
• Investigator Site #10 — Pontiac, Michigan, United States (Recruiting)
• Investigator Site #4 — Chattanooga, Tennessee, United States (Recruiting)
• Investigator Site #5 — Arlington, Texas, United States (Recruiting)
• Investigator Site #9 — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Akebia Therapeutics

Conditions Focal Segmental Glomerulosclerosis; Glomerular Disease; Chronic Kidney Disease; Proteinuria; Urine protein-to-creatinine ratio