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: 30

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 period for an additional 24 weeks. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.

Conditions

Focal Segmental Glomerulosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  Baseline (Day 1) and up to Week 24

• Proportion of participants with TEAEs, serious adverse events (SAEs), and treatment-emergent adverse events of special interest (AESIs). (Part A)

  Time Frame: Up to Week 52

Secondary Outcomes (3)

• Percentage of Participants with Partial Remission at Week 24 (Part A)

  Up to Week 24

• Plasma concentrations of praliciguat (Part A)

  Week 24, Week 32, and Week 36

• Incidence of TEAEs, SAEs, and AESIs in the long-term safety extension (Part B)

  From Week 48 Part A through study completion

Study Arms (3)

Praliciguat (Part A)

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 (Part A)

Placebo (Part A)

PLACEBO COMPARATOR

Matching placebo will be administered daily for 24 weeks

Other: Placebo (Part A)

Experimental: Long-term safety extension praliciguat (Part B)

EXPERIMENTAL

Praliciguat will be administered daily

Drug: Praliciguat (Part B)

Interventions

Praliciguat (Part A) DRUG

Oral Tablet

Praliciguat (Part A)

Placebo (Part A) OTHER

Oral Tablet

Placebo (Part A)

Praliciguat (Part B) DRUG

Oral Tablet

Experimental: Long-term safety extension praliciguat (Part B)

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 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.

You may not qualify if:

• Collapsing FSGS in the kidney biopsy report.
• Sickle cell disease.
• HbA1c \>8%.
• Uncontrolled hypertension (≥160/100 millimeters of mercury).
• \. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.

Sponsors & Collaborators

• Akebia Therapeutics: lead

Study Sites (30)

Investigator Site #2

Chula Vista, California, 91910, United States

RECRUITING

Investigator Site #28

Garden Grove, California, 92844, United States

RECRUITING

Investigator Site #14

Los Angeles, California, 90022, United States

RECRUITING

Investigator Site #12

San Dimas, California, 91773, United States

RECRUITING

Investigator Site #13

Arvada, Colorado, 80002, United States

RECRUITING

Investigator Site #17

Boca Raton, Florida, 33431, United States

RECRUITING

Investigator Site #6

Coral Springs, Florida, 33071, United States

RECRUITING

Investigator Site #25

Hialeah, Florida, 33010, United States

RECRUITING

Investigator Site #7

Miami, Florida, 33172, United States

RECRUITING

Investigator Site #8

Orlando, Florida, 32806, United States

RECRUITING

Investigator Site #29

Augusta, Georgia, 30901, United States

RECRUITING

Investigator Site # 1

Lawrenceville, Georgia, 30046, United States

RECRUITING

Investigator Site #3

Chicago, Illinois, 60643, United States

TERMINATED

Investigator Site #11

Louisville, Kentucky, 40205, United States

RECRUITING

Investigator Site #24

Worcester, Massachusetts, 01608, United States

RECRUITING

Investigator Site #15

Livonia, Michigan, 48152, United States

RECRUITING

Investigator Site #10

Pontiac, Michigan, 48341, United States

RECRUITING

Investigator Site #27

Valhalla, New York, 10595, United States

RECRUITING

Investigator Site #16

New Bern, North Carolina, 28562, United States

RECRUITING

Investigator Site #20

Cleveland, Ohio, 44106, United States

RECRUITING

Investigator Site #30

Bethlehem, Pennsylvania, 18017, United States

RECRUITING

Investigator Site #19

Bridgeville, Pennsylvania, 15017, United States

RECRUITING

Investigator Site #22

Butler, Pennsylvania, 16001, United States

RECRUITING

Investigator Site #23

Goose Creek, South Carolina, 29445, United States

RECRUITING

Investigator Site #4

Chattanooga, Tennessee, 37404, United States

RECRUITING

Investigator Site #5

Arlington, Texas, 76015, United States

RECRUITING

Investigator Site #21

Dallas, Texas, 75230, United States

RECRUITING

Investigator Site #9

Dallas, Texas, 75231, United States

RECRUITING

Investigator Site #18

Houston, Texas, 48152, United States

RECRUITING

Investigator Site #26

Roanoke, Virginia, 24014, 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: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)