RecruitingNot ApplicableNCT06150742

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


Sponsor

Talphera, Inc

Enrollment

70 participants

Start Date

Aug 15, 2024

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

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

DEVICENiyad (nafamostat mesylate)

Niyad (nafamostat mesylate) lyophilized

DEVICEPlacebo (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

View Full Details on ClinicalTrials.gov

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NCT06150742


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