Nafamostat Efficacy in Phase 3 Registrational CRRT Study

Description

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.

Conditions

Acute Kidney Injury

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Study Overview

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Study Details

Study overview

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.

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

Nafamostat Efficacy in Phase 3 Registrational CRRT Study

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest, Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours
  • * Patients who cannot tolerate heparin or are at high risk of bleeding
  • * Patients weighing less than 50 kg
  • * Patients receiving systemic anticoagulation
  • * Patients with active bleeding

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Talphera, Inc,

Study Record Dates

2024-12