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

August 11, 2026 updated by: Akebia Therapeutics

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91910
        • Recruiting
        • Investigator Site #2
      • Los Angeles, California, United States, 90022
        • Recruiting
        • Investigator Site #14
      • San Dimas, California, United States, 91773
        • Recruiting
        • Investigator Site #12
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Recruiting
        • Investigator Site #13
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Recruiting
        • Investigator Site #17
      • Coral Springs, Florida, United States, 33071
        • Recruiting
        • Investigator Site #6
      • Hialeah, Florida, United States, 33010
        • Recruiting
        • Investigator Site #25
      • Miami, Florida, United States, 33172
        • Recruiting
        • Investigator Site #7
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Investigator Site #8
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Recruiting
        • Investigator Site # 1
    • Illinois
      • Chicago, Illinois, United States, 60643
        • Terminated
        • Investigator Site #3
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Investigator Site #11
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Recruiting
        • Investigator Site #24
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Recruiting
        • Investigator Site #15
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Investigator Site #10
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Recruiting
        • Investigator Site #16
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Investigator Site #20
    • Pennsylvania
      • Bridgeville, Pennsylvania, United States, 15017
        • Recruiting
        • Investigator Site #19
      • Butler, Pennsylvania, United States, 16001
        • Recruiting
        • Investigator Site #22
    • South Carolina
      • Goose Creek, South Carolina, United States, 29445
        • Recruiting
        • Investigator Site #23
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Investigator Site #4
    • Texas
      • Arlington, Texas, United States, 76015
        • Recruiting
        • Investigator Site #5
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Investigator Site #9
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Investigator Site #21
      • Houston, Texas, United States, 48152
        • Recruiting
        • Investigator Site #18

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Praliciguat
Praliciguat will be administered daily with dose escalation to a target dose during a 24-week double-blind period, followed by a 24-week open-label treatment period.
Drug: Praliciguat
Oral Tablet
Placebo Comparator: Placebo
Matching placebo will be administered daily for 24 weeks
Other: Placebo
Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in urine protein-to-creatinine ratio (UPCR)
Time Frame: Baseline (Day 1) and up to Week 24
Baseline (Day 1) and up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Partial Remission at Week 24
Time Frame: Up to Week 24
Partial remission is defined as 40% UPCR reduction and UPCR<1.5 gram/gram (g/g).
Up to Week 24
Plasma concentrations of praliciguat
Time Frame: Week 24, Week 32, and Week 36
Week 24, Week 32, and Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akebia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKB-1973-CI-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe