A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects (ACT-AKI)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects|
- Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values. [ Time Frame: Within 30 days of dosing. ] [ Designated as safety issue: No ]The first occurrence of a post-dosing serum creatinine level that is equal to or less than the subject's pre-operative baseline level.
- All-Cause Mortality or Dialysis (composite endpoint). [ Time Frame: Subjects who died or received dialysis within 30 and 90 days after dosing. ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: AC607
Treatment with AC607
AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
Placebo Comparator: Placebo
Treatment with Placebo
Biological: Vehicle Only
The dose will be calculated and recorded in the same way as for AC607.
The study will enroll post-cardiac surgery subjects (CABG and/or valve) with laboratory evidence of AKI within 48 hrs of removal from cardiopulmonary bypass. Subjects will be randomly assigned (1:1 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).
|Contact: Elizabeth A LaPointe, MAemail@example.com|
|Contact: Viken Paragamian, BScfirstname.lastname@example.org|
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|Study Director:||Viken Paragamian|