Nafamostat Efficacy in Phase 3 Registrational CRRT Study (NEPHRO)

Talphera

Status: Enrolling

Conditions: Acute Kidney Injury

Treatments: Device: Niyad (nafamostat mesylate); Device: Placebo (0.9% NaCl)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06150742

NYD301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

166 participants in 2 patient groups, including a placebo group

Niyad

Experimental group

Description:

1 mg/mL infusion of nafamostat mesylate

Treatment:

Device: Niyad (nafamostat mesylate)

Placebo

Placebo Comparator group

Description:

0.9% saline infusion

Treatment:

Device: Placebo (0.9% NaCl)