Nafamostat Efficacy in Phase 3 Registrational CRRT Study

NCT ID: NCT06150742

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Niyad

1 mg/mL infusion of nafamostat mesylate

Group Type EXPERIMENTAL

Niyad (nafamostat mesylate)

Intervention Type DEVICE

Niyad (nafamostat mesylate) lyophilized

Placebo

0.9% saline infusion

Group Type PLACEBO_COMPARATOR

Placebo (0.9% NaCl)

Intervention Type DEVICE

0.9% NaCl

Interventions

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Niyad (nafamostat mesylate)

Niyad (nafamostat mesylate) lyophilized

Intervention Type DEVICE

Placebo (0.9% NaCl)

0.9% NaCl

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Talphera, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

AdventHealth

Orlando, Florida, United States

Site Status NOT_YET_RECRUITING

Henry Ford Health

Detroit, Michigan, United States

Site Status RECRUITING

University of New Mexico

Albuquerque, New Mexico, United States

Site Status RECRUITING

Northwell Health

Great Neck, New York, United States

Site Status RECRUITING

Mount Sinai

New York, New York, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Baylor University Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nazneen Patel

Role: CONTACT

647-724-5709 ext. 305

Chris Houchins

Role: CONTACT

Facility Contacts

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Senior Clinical Research Associate

Role: primary

Program Manager Study Intake

Role: primary

Clinical Study Coordinator

Role: primary

Nurse Research Coordinator

Role: primary

Clinical Research Coordinator

Role: primary

Clinical Research Assistant

Role: primary

Clinical Research Manager

Role: primary

Assistant Director, Laboratory Operations

Role: primary

Clinical Research Coordinator

Role: primary

Research Nurse 1

Role: primary

Other Identifiers

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NYD301

Identifier Type: -

Identifier Source: org_study_id

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