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

NCT07268638 | Recruiting Phase 2 FDA Drug

• 1 other identifier: AKB-1973-CI-0001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Focal Segmental Glomerulosclerosis

Keywords

Glomerular Disease; Chronic Kidney Disease; Proteinuria; Urine protein-to-creatinine ratio

Outcome Measures

Primary Outcomes (1)

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

  Baseline (Day 1) and up to Week 24

Secondary Outcomes (1)

• Percentage of Participants with Partial Remission at Week 24

  Up to Week 24

Study Arms (2)

Praliciguat

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Matching placebo will be administered daily for 24 weeks

Other: Placebo

Interventions

Praliciguat DRUG

Oral Tablet

Praliciguat

Placebo OTHER

Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• UPCR ≥1 (g/g) during screening.
• On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.
• Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• Kidney biopsy within 3 years of screening consistent with FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.

You may not qualify if:

• Collapsing FSGS in the kidney biopsy report.
• Sickle cell disease.
• HbA1c \>8% or non-fasting blood glucose \>180 milligram/decilitre.
• Uncontrolled hypertension (≥160/100 millimeters of mercury)

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (10)

Investigator Site #2

Chula Vista, California, 91910, United States

RECRUITING

Investigator Site #6

Coral Springs, Florida, 33071, United States

RECRUITING

Investigator Site #7

Miami, Florida, 33172, United States

RECRUITING

Investigator Site #8

Orlando, Florida, 32806, United States

RECRUITING

Investigator Site # 1

Lawrenceville, Georgia, 30046, United States

RECRUITING

Investigator Site #3

Chicago, Illinois, 60643, United States

RECRUITING

Investigator Site #10

Pontiac, Michigan, 48341, United States

RECRUITING

Investigator Site #4

Chattanooga, Tennessee, 37404, United States

RECRUITING

Investigator Site #5

Arlington, Texas, 76015, United States

RECRUITING

Investigator Site #9

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental; Renal Insufficiency, Chronic; Proteinuria

Interventions

praliciguat

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Central Study Contacts

Akebia Therapeutics

CONTACT

16178446128; trials@akebia.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 8, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)