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NCT07268638PHASE2Recruiting

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

Akebia Therapeutics

Start Date

12/3/2025

Completion Date

1/1/2028

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 Criteria

Age Range: 18 years to No maximum

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).

Interventions

DRUG

Praliciguat

OTHER

Placebo

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Conditions

Focal Segmental Glomerulosclerosis

Locations

Investigator Site #2

Chula Vista, California 91910

United States

Investigator Site #14

Los Angeles, California 90022

United States

Investigator Site #12

San Dimas, California 91773

United States

Investigator Site #13

Arvada, Colorado 80002

United States

Investigator Site #17

Boca Raton, Florida 33431

United States

Investigator Site #6

Coral Springs, Florida 33071

United States

Investigator Site #7

Miami, Florida 33172

United States

Investigator Site #8

Orlando, Florida 32806

United States

Investigator Site # 1

Lawrenceville, Georgia 30046

United States

Investigator Site #3

Chicago, Illinois 60643

United States

Investigator Site #11

Louisville, Kentucky 40205

United States

Investigator Site #15

Livonia, Michigan 48152

United States

Investigator Site #10

Pontiac, Michigan 48341

United States

Investigator Site #16

New Bern, North Carolina 28562

United States

Investigator Site #20

Cleveland, Ohio 44106

United States

Investigator Site #19

Bridgeville, Pennsylvania 15017

United States

Investigator Site #22

Butler, Pennsylvania 16001

United States

Investigator Site #23

Goose Creek, South Carolina 29445

United States

Investigator Site #4

Chattanooga, Tennessee 37404

United States

Investigator Site #5

Arlington, Texas 76015

United States

Investigator Site #21

Dallas, Texas 75230

United States

Investigator Site #9

Dallas, Texas 75231

United States

Investigator Site #18

Houston, Texas 48152

United States