Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ciclosporin to Protect Renal Function In Cardiac Surgery (CiPRICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397213
Recruitment Status : Completed
First Posted : March 24, 2015
Last Update Posted : October 13, 2016
Sponsor:
Collaborator:
NeuroVive Pharmaceutical AB
Information provided by (Responsible Party):
Region Skane

Tracking Information
First Submitted Date  ICMJE March 12, 2015
First Posted Date  ICMJE March 24, 2015
Last Update Posted Date October 13, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2015)
Ciclosporin to Protect Renal function In Cardiac Surgery. [ Time Frame: up to day 3 ]
Relative P-CyC change from day -1 to day 3.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ciclosporin to Protect Renal Function In Cardiac Surgery
Official Title  ICMJE Ciclosporin to Protect Renal Function In Cardiac Surgery: CiPRICS A Phase II Double Blind Randomized Placebo Controlled Study
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • Drug: Ciclosporin
    Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection preoperatively after anesthesia induction.
    Other Name: CicloMulsion® ATC-code: CO1EB
  • 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).
Study Arms  ICMJE
  • Placebo Comparator: 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).
    Intervention: Drug: Placebo
  • Active Comparator: Ciclosporin
    Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection.
    Intervention: Drug: Ciclosporin
Publications * Ederoth P, Grins E, Dardashti A, Brondén B, Metzsch C, Erdling A, Nozohoor S, Mokhtari A, Hansson MJ, Elmér E, Algotsson L, Jovinge S, Bjursten H. Ciclosporin to Protect Renal function In Cardiac Surgery (CiPRICS): a study protocol for a double-blind, randomised, placebo-controlled, proof-of-concept study. BMJ Open. 2016 Dec 15;6(12):e012299. doi: 10.1136/bmjopen-2016-012299.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2016)
155
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2015)
150
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02397213
Other Study ID Numbers  ICMJE 2014-004610-29
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Region Skane
Study Sponsor  ICMJE Region Skane
Collaborators  ICMJE NeuroVive Pharmaceutical AB
Investigators  ICMJE
Principal Investigator: Henrik Bjursten, Md, PhD Skane University Hospital
PRS Account Region Skane
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP