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NCT Number: NCT07268638

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigator Site #2, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Collapsing FSGS in the kidney biopsy report.
  • Sickle cell disease.
  • HbA1c >8%.
  • Uncontrolled hypertension (≥160/100 millimeters of mercury).

Treatment and study plan

Praliciguat

Drug

Oral Tablet

Placebo

Other

Oral Tablet

Primary outcomes

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

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

Secondary outcomes

  1. 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).

  2. Plasma concentrations of praliciguat

    Time frame: Week 24, Week 32, and Week 36

Study contacts

Contact information is provided by the study sponsor or research team.

Akebia Therapeutics

CONTACT

[email protected]

16178446128

Sponsors and collaborators

Lead sponsor

Akebia Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 8, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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