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

Phase 2RecruitingNCT07268638

Akebia Therapeutics60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Focal Segmental Glomerulosclerosis

Interventions

PraliciguatDRUG

Oral Tablet

PlaceboOTHER

Oral Tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (8)

Investigator Site #2

Chula Vista, California, United States

RECRUITING

Investigator Site #6

Coral Springs, Florida, United States

RECRUITING

Investigator Site #7

Miami, Florida, United States

Outcomes

Primary Outcomes

Change from Baseline in urine protein-to-creatinine ratio (UPCR)

Time frame: Baseline (Day 1) and up to Week 24

Secondary Outcomes

Percentage of Participants with Partial Remission at Week 24

Partial remission is defined as 40% UPCR reduction and UPCR\<1.5 gram/gram (g/g).

Time frame: Up to Week 24

Central Contacts

Akebia Therapeutics

CONTACT

16178446128 trials@akebia.com

Data from ClinicalTrials.gov

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