NCT01336959

Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery

A Two-part, Randomized, Double-blind, Placebo-controlled, Single Dose Study of BCT197 for the Prevention of Acute Kidney Injury (AKI) in Patients Undergoing Elective Cardiac Surgery With Cardiopulmonary Bypass (CPB)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Mereo BioPharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	BCT197 Part A	open label single dose administration of 10mg BCT197, 2 hours prior to surgery
DRUG	Placebo	Single dose matching placebo administered 2 prior to surgery
DRUG	BCT197 Part B	BCT197 50mg single dose administered 2 hours prior to surgery

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-04-18
• Last updated: 2020-11-06
• Results posted: 2018-11-08

Locations

13 sites across 3 countries: United States, Israel, Taiwan