Status:
RECRUITING
Nafamostat Efficacy in Phase 3 Registrational CRRT Study
Lead Sponsor:
Talphera, Inc
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18-80 years
Phase:
NA
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 dia...
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) al...
Eligibility Criteria
Inclusion
- 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
- Patients weighing less than 50 kg
- Patients receiving systemic anticoagulation
- Patients with active bleeding
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06150742
Start Date
August 15 2024
End Date
December 1 2025
Last Update
October 15 2025
Active Locations (10)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095
2
AdventHealth
Orlando, Florida, United States, 32804
3
Henry Ford Health
Detroit, Michigan, United States, 48202
4
University of New Mexico
Albuquerque, New Mexico, United States, 87131