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

Acute Kidney Injury

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Niyad (nafamostat mesylate) and a medical device called Placebo (0.9% NaCl) for people with acute kidney injury. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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