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
Talphera, Inc
Summary
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.
Description
Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceNiyad (nafamostat mesylate)
Niyad (nafamostat mesylate) lyophilized
- DevicePlacebo (0.9% NaCl)
0.9% NaCl
Locations (10)
- University of California Los AngelesLos Angeles, California
- AdventHealthOrlando, Florida
- Henry Ford HealthDetroit, Michigan
- University of New MexicoAlbuquerque, New Mexico
- Northwell HealthGreat Neck, New York
- Mount SinaiNew York, New York