Clinical Trials

1 studies in Kidney injury

1. A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects Rochester, MN View Summary
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   A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   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).

   NCT ID:

   NCT01602328

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   Who can I contact for additional information about this study?

   Rochester: Lavonne Liedl 507-255-1828
                       Shonie L Buenvenida