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

Akebia Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Focal Segmental Glomerulosclerosis

Treatments: Drug: Praliciguat; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07268638

AKB-1973-CI-0001

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Praliciguat

Experimental group

Description:

Praliciguat will be administered daily with dose escalation to a target dose during a 24-week double-blind period, followed by a 24-week open-label treatment period.

Treatment:

Drug: Praliciguat

Placebo

Placebo Comparator group

Description:

Matching placebo will be administered daily for 24 weeks

Treatment:

Other: Placebo