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Ciclosporin to Protect Renal Function In Cardiac Surgery (CiPRICS)

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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

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Ciclosporin Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ciclosporin to Protect Renal Function In Cardiac Surgery: CiPRICS A Phase II Double Blind Randomized Placebo Controlled Study
Study Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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).

Active Comparator: Ciclosporin
Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection.
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




Primary Outcome Measures :
  1. Ciclosporin to Protect Renal function In Cardiac Surgery. [ Time Frame: up to day 3 ]
    Relative P-CyC change from day -1 to day 3.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397213


Locations
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Sweden
Skane University Hospital
Lund, Sweden, 22185
Sponsors and Collaborators
Region Skane
NeuroVive Pharmaceutical AB
Investigators
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Principal Investigator: Henrik Bjursten, Md, PhD Skane University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT02397213     History of Changes
Other Study ID Numbers: 2014-004610-29
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Region Skane:
Ciclosporin
Acute Kidney injury
Cardiac surgery
Ischemia
Safety
Cystatin C

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors