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

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: Focal Segmental Glomerulosclerosis
• Intervention / Treatment: Drug: Praliciguat; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Akebia Therapeutics; Phone Number: 16178446128; Email: trials@akebia.com

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
    • Coral Springs, Florida, United States, 33071
      • Recruiting
      • Investigator Site #6
    • 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
  • Michigan
    • Pontiac, Michigan, United States, 48341
      • Recruiting
      • Investigator Site #10
  • 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

Participation Criteria

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 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	Partial remission is defined as 40% UPCR reduction and UPCR<1.5 gram/gram (g/g).	Up to Week 24

Collaborators and Investigators

• Sponsor: Akebia Therapeutics

Study record dates

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): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Proteinuria; Glomerular Disease; Urine protein-to-creatinine ratio
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Urination Disorders; Urological Manifestations; Renal Insufficiency; Glomerulonephritis; Nephritis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency, Chronic; Proteinuria; Glomerulosclerosis, Focal Segmental; praliciguat
• 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