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RECRUITING
NCT06150742
NA

Nafamostat Efficacy in Phase 3 Registrational CRRT Study

Sponsor: Talphera, Inc

View on ClinicalTrials.gov

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

Interventions

DEVICE

Niyad (nafamostat mesylate)

Niyad (nafamostat mesylate) lyophilized

DEVICE

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