Recruiting

Nafamostat

Sponsor:

Talphera, Inc

Code:

NCT06150742

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Niyad (nafamostat mesylate)

Placebo (0.9% NaCl)

Study Details

Brief summary:

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.

Conditions

Acute Kidney Injury

Study ID

NCT06150742

Start date

Aug 15, 2024

Status verified date

Oct, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Niyad

1 mg/mL infusion of nafamostat mesylate

placebo comparator: Placebo

0.9% saline infusion

Interventions

Niyad (nafamostat mesylate)

Niyad (nafamostat mesylate) lyophilized

Placebo (0.9% NaCl)

0.9% NaCl

Primary outcome measure

  • mean post-filter activated clotting time (ACT) [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Nazneen Patel

647-724-5709nazneen.patel@clinchoice.com

Chris Houchins

chris.houchins@clinchoice.com

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Northwell Health

Recruiting

Great Neck, New York, United States, 11021

Mount Sinai

Recruiting

New York, New York, United States, 10029

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

More Information

Sponsor

Talphera, Inc

Last update posted

Oct 15, 2025

Last verified

Oct, 2024

Keywords

  • continuous renal replacement therapy
  • anticoagulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Talphera, Inc on 2025-10-15.