Nafamostat Efficacy in Phase 3 Registrational CRRT Study

Launched by TALPHERA, INC · Nov 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Niyad (nafamostat mesylate) to see how well it works for patients with acute kidney injury who need a special type of dialysis called Continuous Renal Replacement Therapy (CRRT). The trial is looking for patients who cannot use a common blood thinner called heparin or are at a higher risk of bleeding. Participants will be randomly assigned to receive either Niyad or a placebo (which looks like the medication but has no active ingredients) to compare the safety and effectiveness of Niyad during their treatment.

To be eligible for the trial, patients need to be between the ages of 65 and 74 or 29 and 219, and they must be in the hospital needing CRRT within the last 48 hours. However, patients who weigh less than 50 kg, are already on other blood thinners, or have active bleeding cannot participate. If you or a loved one joins this study, you can expect close monitoring and support while researchers gather important information about the use of Niyad in this specific situation. This trial is currently recruiting participants, and it's an important step in finding safer options for those who need CRRT but cannot use heparin.

Gender

ALL

Eligibility criteria

• 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