Evaluating nafamostat for anticoagulation in patients with acute kidney injury undergoing dialysis
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
This study is testing if nafamostat can safely prevent blood clots in patients with acute kidney injury who are on dialysis and can't use heparin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Talphera, Inc Industry-sponsored |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT06150742 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of nafamostat mesylate (Niyad) as an anticoagulant in patients undergoing continuous renal replacement therapy (CRRT) who cannot tolerate heparin or are at higher risk for bleeding. The study is a prospective, randomized, placebo-controlled design, focusing on patients in intensive care units with acute kidney injury. By using nafamostat, which has a very short half-life, the trial aims to minimize patient exposure while effectively preventing clotting in the CRRT circuit. The primary objective is to compare the anticoagulation efficacy of nafamostat against a placebo, along with evaluating its safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are patients in intensive care units requiring CRRT who cannot tolerate heparin or are at high risk for bleeding.
Not a fit: Patients weighing less than 50 kg, those receiving systemic anticoagulation, or those with active bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer anticoagulation option for critically ill patients undergoing dialysis, potentially reducing complications associated with heparin.
How similar studies have performed: While nafamostat is already approved for use in South Korea and Japan, this study represents a novel application in the context of CRRT in the United States.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * Patients weighing less than 50 kg * Patients receiving systemic anticoagulation * Patients with active bleeding
Where this trial is running
Los Angeles, California and 9 other locations
- University of California Los Angeles — Los Angeles, California, United States (Recruiting)
- AdventHealth — Orlando, Florida, United States (Not_yet_recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- Northwell Health — Great Neck, New York, United States (Recruiting)
- Mount Sinai — New York, New York, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Baylor University Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Nazneen Patel
- Email: nazneen.patel@clinchoice.com
- Phone: 647-724-5709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.