RECRUITING

Nafamostat Efficacy in Phase 3 Registrational CRRT Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-08-15
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06150742

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours
  2. * Patients who cannot tolerate heparin or are at high risk of bleeding
  1. * Patients weighing less than 50 kg
  2. * Patients receiving systemic anticoagulation
  3. * Patients with active bleeding

Contacts and Locations

Study Contact

Nazneen Patel
CONTACT
647-724-5709
nazneen.patel@clinchoice.com
Chris Houchins
CONTACT
chris.houchins@clinchoice.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Talphera, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15
Study Completion Date2024-12

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • continuous renal replacement therapy
  • anticoagulation

Additional Relevant MeSH Terms

  • Acute Kidney Injury