Multicenter, prospective, randomized, open-label study of the safety and efficacy of a Certican® -based regimen versus a calcineurin inhibitor (CNI)-based regimen in maintenance heart transplant recipients with CNI-related renal insufficiency - CeCaRi
- Conditions
- This study is designed to evaluate whether Certican® initiation, together with discontinuation of calcineurin inhibitors (CNIs) will have a beneficial effect on the renal function in maintenance heart transplant recipients with CNI-related renal impairment, while maintaining efficacy.
- Registration Number
- EUCTR2007-002102-22-BE
- Lead Sponsor
- Gasthuisberg Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
•Male or female over 18 years old
•Patients who have undergone a heart transplantation at least 12 months ago
•Patients with a calculated GFR (MDRD formula) = 60 ml/min and = 30 ml/min/1.73m2 (CKD stage 3)
•Patients who are willing and capable to participate in the study for 12 months and who have given written informed consent.
•Females capable of becoming pregnant must have a negative pregnancy test within 7 days prior to randomization and are required to practice a medically approved method of birth control for the duration of the study.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Dialysed patients
•Patients with any treated acute rejection within 6 months prior to randomization
•Patients with an identifiable cause of renal dysfunction other than CNI toxicity
•Patients with platelet count = 75.000/mm3 or white blood cell count = 2.500/mm3 or hemoglobin value = 8 g/dL
•Patients with proteinuria = 0.8 g/24h
•Presence of a severe hypercholesterolemia (total cholesterol ? 9 mmol/l; ? 350mg/dl) or hypertriglyceridemia (? 8.5 mmol/l, ? 750 mg/dl) despite lipid lowering therapy
•Patients with a current severe systemic infection
•Patients with any history(within the past 5 years) or currently suffering from a malignancy, with an expected life-span of less than 2 years
•Patients currently being treated with a mTOR inhibitor
•Patients with a known intolerance or hypersensitivity to Certican® (everolimus) or similar drugs.
•Severe hepatic disorders
•Patients suffering from chronic hepatitis C (PCR positive) or who are HIV- or HBsAg-positive. The result of a laboratory test performed within the 6 months preceding the inclusion must be available.
•Patients with a significant mental illness, which in the opinion of the investigator may interfere with patients’ ability to comply with the protocol.
•Women who are pregnant or breastfeeding
•Patients who have received an investigational drug within 4 weeks prior to study enrolment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method