Nafamostat for Anticoagulation During CRRT in Acute Kidney Injury

This study is looking at how well Niyad (nafamostat mesylate) works to prevent blood clots in the dialysis machine (CRRT circuit) for people with acute kidney injury. This is for patients who cannot use heparin or have a high risk of bleeding. You might be able to join if you are between 18 and 80 years old and need continuous renal replacement therapy (CRRT) or started it within the last 48 hours. You cannot join if you weigh less than 50 kg, are already on blood thinners, or have active bleeding. The study will compare Niyad to a placebo (a salt water solution) to see which is better at preventing clots in the dialysis filter after 24 hours. The current recruitment status is unclear.

Study design
This is a prospective, randomized, placebo-controlled study with a planned enrollment of 70 participants. Participants will receive either Niyad or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 24 hours, focusing on post-filter activated clotting time.

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NCT06150742

Nafamostat Efficacy in Phase 3 Registrational CRRT Study

Recruiting
NAAges 18–80InterventionalTreatment
Talphera, Inc
~70 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:Niyad (nafamostat mesylate)Placebo (0.9% NaCl)

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
mean post-filter activated clotting time (ACT)
Measured over 24 hours
Acute Kidney Injury
10 sites across 9 states
New York2
California1
Florida1
Michigan1
New Mexico1
Ohio1
Pennsylvania1
South Carolina1

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Eligibility criteria

Inclusion

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

Patients weighing less than 50 kg
Patients receiving systemic anticoagulation
Patients with active bleeding
  • mean post-filter activated clotting time (ACT)24 hours

    mean post-filter activated clotting time (ACT)