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Rochester, Minn.
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A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects
Location:
Rochester, Minn.
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
Who can I contact for additional information about this study?