A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects (ACT-AKI)
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|ClinicalTrials.gov Identifier: NCT01602328|
Recruitment Status : Terminated
First Posted : May 21, 2012
Last Update Posted : August 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Kidney Injury||Biological: AC607 Biological: Vehicle Only||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||August 2014|
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.
- Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values. [ Time Frame: Within 30 days of dosing. ]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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602328
|Study Director:||Viken Paragamian|