Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150742
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-11-21
Brief Title:
Nafamostat Efficacy in Phase 3 Registrational CRRT Study
Sponsor:
Talphera Inc
Organization:
Talphera Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEPHRO
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None