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.
Conditions
Interventions
Trade Name: Certican
Pharmaceutical Form: Tablet
Sponsors
Gasthuisberg Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Change in renal function assessed by mGFR from baseline to month 12 after randomization between the group of patients receiving Certican® and the control group with unchanged CNI-based immunosuppressive treatment. ;Primary end point(s): • Change in renal function assessed by mGFR from baseline to month 12 after randomization between the group of patients receiving Certican® and the control group with unchanged CNI-based immunosuppressive treatment. ;Secondary Objective: • Incidence of treated acute rejection episodes • Proteinuria (protein/creatinine ratio, measured in first morning urine sample) • Incidence of graft loss/retransplantation • Patient survival • Ultrasound left ventricular ejection fraction • Incidence of MACEs. MACEs include: acute myocardial infarction, congestive heart failure, percutaneous coronary intervention (PCI), automatic implanted cardiac defibrillator (AICD), coronary artery bypass graft surgery (CABG), cerebral vascular accident, and peripheral vascular disease. • Calculated GFR (cGFR n-MDRD formula) change from baseline. • Ambulatory 24h blood pressure monitoring • Safety parameters including: hypertension, diabetes mellitus, hyperlipidemia, anemia, infections and malignancies • Incidence of discontinuations, AEs and SAEs | — |
Countries
Belgium
Outcome results
None listed