Ciclosporin to Protect Renal Function In Cardiac Surgery

Acute Kidney Injury Clinical Trial

— CiPRICS  

Official title:

Ciclosporin to Protect Renal Function In Cardiac Surgery: CiPRICS A Phase II Double Blind Randomized Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397213
• Other study ID #: 2014-004610-29
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2015
• Last updated: October 12, 2016
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the potential of ciclosporin in reducing risk and degree of acute kidney injury after cardiac surgery.

Description:

Acute kidney injury (AKI) is a common complication after cardiac surgery and is associated with decreased long-term survival. The mechanism for inducing acute kidney injury is unknown but ischaemia-reperfusion injury is indicated to be a part of the cause.

Animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of ciclosporin in ischaemia-reperfusion injury in the kidney. The major mechanism is thought to be inhibition of the reperfusion triggered opening of the mitochondrial permeability transition pore (mPTP), responsible for reperfusion-induced necrosis. During cardiac surgery, the period of extracorporeal circulation (ECC) changes the perfusion through the kidney. Return to normal perfusion with a beating heart has similarities with reperfusion following ischemia.

Administration of ciclosporin in conjunction with percutaneous coronary intervention (PCI), heart surgery and traumatic brain injury (TBI) in humans has shown to be safe with no direct side-effects.

The investigators therefore hypothesize that a preconditioning effect of ciclosporin before coronary artery bypass grafting (CABG) can reduce the level of renal dysfunction after this type of cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Non-emergent CABG

• Written informed consent to participate

• Preoperative CyC eGFR or MDRD eGFR is 90-15.

Exclusion Criteria:

• Uncontrolled hypertension

• Hypersensitivity to ciclosporin or any of the excipients of the lipid emulsion, including egg-, soya- or peanut protein

• Pregnancy or fertile woman

• Ciclosporin treatment within 4 weeks

• Ongoing malignancy, ongoing immunosuppressive treatment, severe hepatic dysfunction, dialysis or severe infection

• Ongoing medication with dabigatran, aliskiren, bosentan, stiripentol, glibenclamid, St John's worth, or

• Off-pump surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	NeuroVive Pharmaceutical AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ciclosporin to Protect Renal function In Cardiac Surgery.	Relative P-CyC change from day -1 to day 3.	up to day 3	Yes