Nafamostat Efficacy in Phase 3 Registrational CRRT Study
NCT06150742 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-10-15
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
Interventions
- DEVICE
-
Niyad (nafamostat mesylate)
Niyad (nafamostat mesylate) lyophilized
- DEVICE
-
Placebo (0.9% NaCl)
0.9% NaCl
Sponsors & Collaborators
-
Talphera, Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-15
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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