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Nafamostat Efficacy in Phase 3 Registrational CRRT Study (NEPHRO)

T

Talphera

Status

Enrolling

Conditions

Acute Kidney Injury

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

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)

Trial contacts and locations

1

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Central trial contact

Chris Houchins; Nazneen Patel

Data sourced from clinicaltrials.gov

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