A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS) (NCT07268638)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).
Location: Investigator Site #2 — Chula Vista, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Collapsing FSGS in the kidney biopsy report.
- Sickle cell disease.
- HbA1c \>8%.
- Uncontrolled hypertension (≥160/100 millimeters of mercury).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (25 Sites)
- Investigator Site #2 — Chula Vista, California
- Investigator Site #14 — Los Angeles, California
- Investigator Site #12 — San Dimas, California
- Investigator Site #13 — Arvada, Colorado
- Investigator Site #17 — Boca Raton, Florida
- Investigator Site #6 — Coral Springs, Florida
- Investigator Site #25 — Hialeah, Florida
- Investigator Site #7 — Miami, Florida
- Investigator Site #8 — Orlando, Florida
- Investigator Site # 1 — Lawrenceville, Georgia
- Investigator Site #3 — Chicago, Illinois
- Investigator Site #11 — Louisville, Kentucky
- Investigator Site #24 — Worcester, Massachusetts
- Investigator Site #15 — Livonia, Michigan
- Investigator Site #10 — Pontiac, Michigan
- Investigator Site #16 — New Bern, North Carolina
- Investigator Site #20 — Cleveland, Ohio
- Investigator Site #19 — Bridgeville, Pennsylvania
- Investigator Site #22 — Butler, Pennsylvania
- Investigator Site #23 — Goose Creek, South Carolina
- Investigator Site #4 — Chattanooga, Tennessee
- Investigator Site #5 — Arlington, Texas
- Investigator Site #21 — Dallas, Texas
- Investigator Site #9 — Dallas, Texas
- Investigator Site #18 — Houston, Texas
📞 Contact the Study Coordinator
Phone: (617) 844-6128
Email: trials@akebia.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Following this double-blind period, all participants will receive praliciguat in an open-label extension for an additional 24 weeks.
More studies in Focal Segmental Glomerulosclerosis
- An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases — Bethesda, Maryland
- Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children — Loma Linda, California
- Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System — Loma Linda, California
- Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases — Los Angeles, California
- Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease — Ann Arbor, Michigan
Explore by condition: All Focal Segmental Glomerulosclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.