Ciclosporin to Protect Renal Function In Cardiac Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

155

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

September 30, 2016

Conditions
Acute Kidney Injury
Interventions
DRUG

Ciclosporin

Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection preoperatively after anesthesia induction.

DRUG

Placebo

All components of the CicloMulsion® emulsion except ciclosporin: soybean oil (refined), triglycerides (medium-chain), egg lecithin, glycerol, oleic acid, sodium hydroxide and water for injection (=0.5 ml/kg).

Trial Locations (1)

22185

Skane University Hospital, Lund

Sponsors
All Listed Sponsors
collaborator

NeuroVive Pharmaceutical AB

INDUSTRY

lead

Region Skane

OTHER