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Nafamostat Efficacy in Phase 3 Registrational CRRT Study
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2024-08-15
Completion Date
2025-12
Last Updated
2025-10-15
Healthy Volunteers
No
Conditions
Interventions
Niyad (nafamostat mesylate)
Niyad (nafamostat mesylate) lyophilized
Placebo (0.9% NaCl)
0.9% NaCl
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