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

NCT07268638 · tracked via the Priya Life Science USA tracker

Sponsor

Akebia Therapeutics

Phase

Phase 2

Started

2025-12-03

Last updated

2026-08-13

Condition(s) studied

Focal Segmental Glomerulosclerosis

Investigational drug(s) / intervention(s)

PraliciguatPlacebo

Praliciguat: Oral Tablet

Placebo: Oral Tablet

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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 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: 1. Collapsing FSGS in the kidney biopsy report. 2. Sickle cell disease. 3. HbA1c \>8%. 4. Uncontrolled hypertension (≥160/100 millimeters of mercury).

Primary outcome measure(s)

Change from Baseline in urine protein-to-creatinine ratio (UPCR) — Baseline (Day 1) and up to Week 24

Trial sites (25)

Facility	City	Region	Status
Investigator Site #2	Chula Vista	California	Recruiting
Investigator Site #14	Los Angeles	California	Recruiting
Investigator Site #12	San Dimas	California	Recruiting
Investigator Site #13	Arvada	Colorado	Recruiting
Investigator Site #17	Boca Raton	Florida	Recruiting
Investigator Site #6	Coral Springs	Florida	Recruiting
Investigator Site #25	Hialeah	Florida	Recruiting
Investigator Site #7	Miami	Florida	Recruiting
Investigator Site #8	Orlando	Florida	Recruiting
Investigator Site # 1	Lawrenceville	Georgia	Recruiting
Investigator Site #3	Chicago	Illinois	Terminated
Investigator Site #11	Louisville	Kentucky	Recruiting
Investigator Site #24	Worcester	Massachusetts	Recruiting
Investigator Site #15	Livonia	Michigan	Recruiting
Investigator Site #10	Pontiac	Michigan	Recruiting
Investigator Site #16	New Bern	North Carolina	Recruiting
Investigator Site #20	Cleveland	Ohio	Recruiting
Investigator Site #19	Bridgeville	Pennsylvania	Recruiting
Investigator Site #22	Butler	Pennsylvania	Recruiting
Investigator Site #23	Goose Creek	South Carolina	Recruiting
Investigator Site #4	Chattanooga	Tennessee	Recruiting
Investigator Site #5	Arlington	Texas	Recruiting
Investigator Site #21	Dallas	Texas	Recruiting
Investigator Site #9	Dallas	Texas	Recruiting
Investigator Site #18	Houston	Texas	Recruiting

More Akebia Therapeutics trials in the USA

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Other trials for the same condition

Atrasentan in Patients With Proteinuric Glomerular Diseases Active, not recruiting

A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS) Recruiting

A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease Recruiting

Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children Recruiting

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07268638 on ClinicalTrials.gov ↗ ← All trials in the USA