Nafamostat Efficacy in Phase 3 Registrational CRRT Study
- Conditions
- Acute Kidney Injury
- Registration Number
- NCT06150742
- Lead Sponsor
- Talphera, Inc
- Brief 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.
- Detailed 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 patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 166
- Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours
- Patients who cannot tolerate heparin or are at high risk of bleeding
- Patients weighing less than 50 kg
- Patients receiving systemic anticoagulation
- Patients with active bleeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method mean post-filter activated clotting time (ACT) 24 hours mean post-filter activated clotting time (ACT)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University of California Los Angeles
🇺🇸Los Angeles, California, United States
AdventHealth
🇺🇸Orlando, Florida, United States
Henry Ford Health
🇺🇸Detroit, Michigan, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Northwell Health
🇺🇸Great Neck, New York, United States
Mount Sinai
🇺🇸New York, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of California Los Angeles🇺🇸Los Angeles, California, United StatesSenior Clinical Research AssociateContact