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RECRUITING
NCT07268638
PHASE2

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

Sponsor: Akebia Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-12-03

Completion Date

2028-01

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Praliciguat

Oral Tablet

OTHER

Placebo

Oral Tablet

Locations (8)

Investigator Site #2

Chula Vista, California, United States

Investigator Site #6

Coral Springs, 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 #4

Chattanooga, Tennessee, United States

Investigator Site #5

Arlington, Texas, United States