Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury Cardiopulmonary Bypass CABG Cardiac Surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.

Detailed description:

Arms:
arm 1: 10mg single dose of BCT197 arm 2: Single dose of 50mg BCT197 arm 3: Single dose of matching placebo to 50mg BCT197

Interventions: intervention 1: BCT197 Part A intervention 2: Placebo intervention 3: BCT197 Part B
Intervention descriptions: intervention 1: open label single dose administration of 10mg BCT197, 2 hours prior to surgery intervention 2: Single dose matching placebo administered 2 prior to surgery intervention 3: BCT197 50mg single dose administered 2 hours prior to surgery

Protocol document: