Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01602328
Status:
TERMINATED
Last Update Posted:
2014-08-06
First Post:
2012-05-17
Brief Title:
A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
Sponsor:
AlloCure Inc
Organization:
AlloCure Inc
Study Overview
Official Title:
A Randomized Multicenter Double-Blind Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects
Status:
TERMINATED
Status Verified Date:
2014-08
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:
ACT-AKI
Brief Summary:
Subjects entering the study will have undergone cardiac surgery Those who experience kidney injury within 48 hours of their surgery will be enrolled into the study Once enrolled subjects will receive a single administration of AC607 or placebo Kidney recovery will be evaluated over the subsequent 30 days and death or the need for dialysis will be evaluated within 90 days of dosing After 90 days evaluation period subjects will enter a 3-year extension phase of the study to monitor safety and long-term outcomes follow-up period
Detailed Description:
The study will enroll post-cardiac surgery subjects CABG andor valve with laboratory evidence of AKI within 48 hrs of removal from cardiopulmonary bypass Subjects will be randomly assigned 11 ratio to treatment with a single administration of AC607 or placebo approximately 100 subjects per group
Safety and efficacy assessments will be performed daily during the post-operative hospital stay from the day randomized into the study until discharge at 30 days and at 90 days after study drug administration evaluation phase Safety and long-term clinical outcomes will be assessed at 6 12 24 and 36 months long-term follow-up phase
Safety and efficacy assessments will be performed daily during the post-operative hospital stay from the day randomized into the study until discharge at 30 days and at 90 days after study drug administration evaluation phase Safety and long-term clinical outcomes will be assessed at 6 12 24 and 36 months long-term follow-up phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None