NCT07268638RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 3 Dec 2025
- Primary completion date
- Jun 2027
- Lead sponsor
- Akebia Therapeutics
- Diseases
- Chronic kidney disease
- NCT number
- NCT07268638
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 3 Dec 2025 to the primary completion date, Jun 2027
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Sickle cell disease.
- Uncontrolled hypertension (≥160/100 millimeters of mercury).
Lab values
- HbA1c \>8%.
Other
- Collapsing FSGS in the kidney biopsy report.
Who the study is looking for
- 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.
- 1\. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.