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RecruitingPhase 2

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

Akebia Therapeutics · NCT07268638

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
60
US sites recruiting
29
Study start
December 3, 2025
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Praliciguat (Part A); Placebo (Part A); Praliciguat (Part B)

Conditions: Focal Segmental Glomerulosclerosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria (Part A):

  • 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 (Part A):

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

Inclusion Criteria (Part B):

  • Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.

Recruiting US locations

Study contacts (from the official record)

  • Akebia Therapeutics · 16178446128 · trials@akebia.com
A Study of Praliciguat in Participants With Focal Segmental… (NCT07268638) | Bored Studies