A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects (ACT-AKI)
|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|
|Study Completion Date:||August 2014|
|Primary Completion Date:||June 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602328
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|Study Director:||Viken Paragamian|