RecruitingPhase 2NCT07268638

A Study of Praliciguat in Participants 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


Sponsor

Akebia Therapeutics

Enrollment

60 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called praliciguat for people with focal segmental glomerulosclerosis (FSGS) — a kidney disease that causes scarring of the kidney's filtering units, leading to significant protein loss in the urine and progressive kidney damage. **You may be eligible if...** - You have significant protein in your urine (urine protein-to-creatinine ratio of 1 or higher) - Your kidney function, while reduced, is not critically impaired (eGFR of at least 25 mL/min/1.73m²) - Your FSGS has been confirmed by kidney biopsy within the past 3 years, or you have a genetic mutation known to cause FSGS - You are already on maximum tolerated doses of standard blood-pressure-protecting kidney medications (ACE inhibitors or ARBs) **You may NOT be eligible if...** - Your kidney biopsy showed a particularly aggressive pattern called "collapsing FSGS" - You have sickle cell disease - Your blood sugar control is poor (HbA1c above 8% or high non-fasting glucose) - Your blood pressure is severely uncontrolled (140/100 mmHg or higher despite medication) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPraliciguat

Oral Tablet

OTHERPlacebo

Oral Tablet


Locations(10)

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 #10

Pontiac, Michigan, United States

Investigator Site #4

Chattanooga, Tennessee, United States

Investigator Site #5

Arlington, Texas, United States

Investigator Site #9

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07268638


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