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Clinical Trials in Mexico / NCT06150742
Recruiting Not applicable

Nafamostat Efficacy in Phase 3 Registrational CRRT Study

NCT06150742 · tracked via the Priya Life Science Mexico tracker
Sponsor
Talphera, Inc
Phase
Not applicable
Started
2024-08-15
Last updated
2025-10-15

Condition(s) studied

Acute Kidney Injury

Investigational drug(s) / intervention(s)

Niyad (nafamostat mesylate)Placebo (0.9% NaCl)

Niyad (nafamostat mesylate): Niyad (nafamostat mesylate) lyophilized

Placebo (0.9% NaCl): 0.9% NaCl

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • mean post-filter activated clotting time (ACT) — 24 hours
    mean post-filter activated clotting time (ACT)

Trial sites (10)

FacilityCityRegionStatus
University of California Los Angeles Los Angeles California Recruiting
AdventHealth Orlando Florida Not Yet Recruiting
Henry Ford Health Detroit Michigan Recruiting
University of New Mexico Albuquerque New Mexico Recruiting
Northwell Health Great Neck New York Recruiting
Mount Sinai New York New York Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Baylor University Medical Center Dallas Texas Recruiting

Other trials for the same condition

Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 Enrolling by invitation
Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America Recruiting
Volume Removal Intolerance During Net Ultrafiltration in Acute Kidney Injury Patients Recruiting
Establishment of ProNephro AKI (NGAL) Cut Off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06150742 on ClinicalTrials.gov ↗ ← All trials in Mexico