Nafamostat Efficacy in Phase 3 Registrational CRRT Study
NEPHRO
A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding
1 other identifier
interventional
70
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2023
CompletedFirst Posted
Study publicly available on registry
November 29, 2023
CompletedStudy Start
First participant enrolled
August 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 15, 2025
October 1, 2024
1.3 years
November 21, 2023
October 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean post-filter activated clotting time (ACT)
mean post-filter activated clotting time (ACT)
24 hours
Study Arms (2)
Niyad
EXPERIMENTAL1 mg/mL infusion of nafamostat mesylate
Placebo
PLACEBO COMPARATOR0.9% saline infusion
Interventions
Eligibility Criteria
You may qualify if:
- Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours
- Patients who cannot tolerate heparin or are at high risk of bleeding
You may not qualify if:
- Patients weighing less than 50 kg
- Patients receiving systemic anticoagulation
- Patients with active bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Talphera, Inclead
Study Sites (10)
University of California Los Angeles
Los Angeles, California, 90095, United States
AdventHealth
Orlando, Florida, 32804, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Northwell Health
Great Neck, New York, 11021, United States
Mount Sinai
New York, New York, 10029, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2023
First Posted
November 29, 2023
Study Start
August 15, 2024
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
October 15, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share