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Nafamostat Efficacy in Phase 3 Registrational CRRT Study
A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours * Patients who cannot tolerate heparin or are at high risk of bleeding Exclusion Criteria: * Patients weighing less than 50 kg * Patients receiving systemic anticoagulation * Patients with active bleeding
About the study
A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients undergoing CRRT who cannot tolerate heparin or are at higher risk for bleeding.
What is being tested
- Niyad (nafamostat mesylate) (device)
- Placebo (0.9% NaCl) (device)
Sponsor: Talphera, Inc · Participants: 70 · Started: Aug 15, 2024
Contact the study team
- Nazneen Patel · Phone: 647-724-5709
Official record on ClinicalTrials.gov — NCT06150742
Locations in the U.S.
| California | University of California Los Angeles, Los Angeles |
| Florida | AdventHealth, Orlando (Not yet recruiting) |
| Michigan | Henry Ford Health, Detroit |
| New Mexico | University of New Mexico, Albuquerque |
| New York | Northwell Health, Great Neck Mount Sinai, New York |
| Ohio | Cincinnati Children's Hospital Medical Center, Cincinnati |
| Pennsylvania | University of Pittsburgh Medical Center, Pittsburgh |
| South Carolina | Medical University of South Carolina, Charleston |
| Texas | Baylor University Medical Center, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.