Talphera Inc. (TLPH)

[Whalatane]

Oh keep the faith

Detailed Description:
Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.
Study Design
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Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

ER MD's needing to dialyze patients ...especially those patients with trauma and bleeding issues ..want FDA approval to use Niyad ...just as the ER MD's are doing in Japan and Korea
Results not to August at earliest . Start of trial was delayed due to administrative issues at the teaching hospitals running this trial
Using Heparin as they do now ...increases the bleeding risk for these patients ..which is why the ER docs want approval to use Niyad
Kiwi