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
Talphera, Inc
70 participants
Aug 15, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria3
- Patients weighing less than 50 kg
- Patients receiving systemic anticoagulation
- Patients with active bleeding
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Interventions
Niyad (nafamostat mesylate) lyophilized
0.9% NaCl
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06150742