Nafamostat Efficacy in Phase 3 Registrational CRRT Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
Talphera, Inc
Study ID
NCT06150742
Status
Recruiting
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Conditions

  • Acute Kidney Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Niyad (nafamostat mesylate) — DEVICE
    Niyad (nafamostat mesylate) lyophilized
  • Placebo (0.9% NaCl) — DEVICE
    0.9% NaCl

Study Details

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.

Key Dates

Start date
Aug 15, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Niyad
    1 mg/mL infusion of nafamostat mesylate
  • Placebo Comparator: Placebo
    0.9% saline infusion

Primary Outcome Measure

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

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095
Senior Clinical Research Associate
AdventHealthOrlandoFlorida32804
Program Manager Study Intake
Henry Ford HealthDetroitMichigan48202
Clinical Study Coordinator
University of New MexicoAlbuquerqueNew Mexico87131
Nurse Research Coordinator
Northwell HealthGreat NeckNew York11021
Clinical Research Coordinator
Mount SinaiNew YorkNew York10029
Clinical Research Assistant
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Clinical Research Manager
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Assistant Director, Laboratory Operations
Medical University of South CarolinaCharlestonSouth Carolina29425
Clinical Research Coordinator
Baylor University Medical CenterDallasTexas75246
Research Nurse 1

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By research site
University of California Los Angeles· Los Angeles, CAAdventHealth· Orlando, FLHenry Ford Health· Detroit, MIUniversity of New Mexico· Albuquerque, NMNorthwell Health· Great Neck, NYMount Sinai· New York, NY

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