Nafamostat Efficacy in Phase 3 Registrational CRRT Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Niyad (nafamostat mesylate), Placebo (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Detailed description
Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.
Interventions
- Device Niyad (nafamostat mesylate)
Niyad (nafamostat mesylate) lyophilized - Device Placebo (0.9% NaCl)
0.9% NaCl
Primary outcome measures
- mean post-filter activated clotting time (ACT) [Time frame: 24 hours]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- University of California Los Angeles — Los Angeles
- AdventHealth — Orlando
- Henry Ford Health — Detroit
- University of New Mexico — Albuquerque
- Northwell Health — Great Neck
- Mount Sinai — New York
- Cincinnati Children's Hospital Medical Center — Cincinnati
- University of Pittsburgh Medical Center — Pittsburgh
- … and 2 more centers
Identifiers
NCT: NCT06150742 · NYD301