Overview

Ciclosporin to Protect Renal Function In Cardiac Surgery

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Region Skane
Collaborator:
NeuroVive Pharmaceutical AB
Treatments:
Cyclosporine
Cyclosporins
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