NCT07268638 A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
| NCT ID | NCT07268638 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Akebia Therapeutics |
| Condition | Focal Segmental Glomerulosclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-12-03 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. UPCR ≥1 (g/g) during screening. 2. On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent. 3. Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. 4. 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: 1. Collapsing FSGS in the kidney biopsy report. 2. Sickle cell disease. 3. HbA1c \>8%. 4. Uncontrolled hypertension (≥160/100 millimeters of mercury).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07268638 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Focal Segmental Glomerulosclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07268638 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07268638 currently recruiting?
Yes, NCT07268638 is actively recruiting participants. Contact the research team at trials@akebia.com for enrollment information.
Where is the NCT07268638 trial being conducted?
This trial is being conducted at Chula Vista, United States, Los Angeles, United States, San Dimas, United States, Arvada, United States and 11 additional locations.
Who is sponsoring the NCT07268638 clinical trial?
NCT07268638 is sponsored by Akebia Therapeutics. The trial plans to enroll 60 participants.