Ciclosporin to Protect Renal function In Cardiac Surgery

Phase 1

• Conditions: Renal dysfunction after CABG surgery; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2014-004610-29-SE
• Lead Sponsor: Skanes University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-22
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.The study patient is scheduled for non-emergent (decision to operate more than one hour before start of surgery) CABG surgery.
2.Preoperative CyC eGFR or MDRD eGFR is 15-90.
eGFR will be calculated using both creatinine (MDRD) and CyC .
The lowest eGFR value will be used as inclusion criteria.
3.The patient has given his/her written consent to participate.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

1.The patient has an uncontrolled hypertension.
2.Hypersensitivity to the active drug or vehicle, including egg-,
soya- or peanut protein;.
3.The patient is pregnant or is a fertile woman.
4.The patient has been treated with ciclosporin within 4 weeks
prior to the surgery.
5.The patient has a known ongoing malignancy.
6.The patient has ongoing immunosuppressive treatment.
7.The patient has severe hepatic dysfunction.
8.The patient is treated with dialysis.
9.The patient has pre-operatively ongoing and/or increasing clinical infection with CRP levels of >50 mg/L. Clinical signs of infection may or may not be present. Increase in CRP due to signs of cardiac origin, according to the investigator, should not be considered as exclusion criteria.
10.The patient has a severe ongoing viral infection, including HIV, hepatitis C, current or history of hepatitis B.
11. For non-allowed and restricted ongoing and concomitant medications, see Protocol section 12.2.
12.The patient is planned for Off-pump CABG surgery.
13.The patient is included in other ongoing clinical trial.
14.For any other reason, the patient is unsuitable to
participate in the study, according to the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified