Preservation of renal function after kidney transplantation in a 5-year, multicentre, prospective, randomized, open-label, controlled study Patients will be randomized within 24 hours prior to transplantation. ? Group 1: Simulect + Neoral + Myfortic + steroid stop at 3 months ? Group 2: Simulect + Neoral (decrease dose in one week at mo 3 and replace by Certican) + Myfortic + steroid maintenance.
Conditions
Interventions
Trade Name: Certican 0.25 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
CAS Number: 159351696
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male or female recipients of a de novo kidney transplant, aged above 18 yrs. ? Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/ml. ? Patients must be capable of understanding the purpose and risks of the study, and must sign an informed consent form 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: ? Multiple organ transplantation (e.g. Kidney-pancreas, kidney-heart, kidney-liver,…) ? Transplantation of a patient who got another organ transplant previously ? Recipients of a HLA-identical living-related renal transplant ? Patients with PRA > 30%, patients who have lost a first graft from rejection within two years after transplantation, and African European patients. ? Patients with primary renal disease at risk for recurrence: FSGS, MPGN, HUS ? Pregnant or lactating women ? WBC < 2.5 x 109/l (IU), platelet count < 100 x 109/l (IU), or Hb < 6 g/dl at the time of entry into the study ? Active peptic ulcer ? Severe diarrhea or other gastrointestinal disorder, which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy ? Known HIV-1 or HTLV-1 positive tests ? The use of investigational drugs or other immunosuppressive drugs, as those specified in this protocol ? Patients receiving bile acid sequestrants ? Psychological illness or condition, interfering with the patient’s compliance or ability to understand the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if superior graft function (GFR difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-Certican plus steroids compared to Myfortic-Neoral. ;Primary end point(s): graft function (GFR measured by 51 CrEDTA clearance) at 1 year ;Secondary Objective: 1. Efficacy variables: To compare the evolution of graft function during the first 5 years post transplantation. To compare the evolution of intragraft lesions (subclinical rejections, fibrosis, vasculopathy, and glomerular lesions) in protocol biopsies at baseline, and at one year. To compare the number and severity of BPAR. To compare patient and graft survival. 2. Safety variables: To compare the incidence of malignancy. To compare the incidence of MACES. To compare the progression of atherosclerosis by means of exploration of carotid artery with doppler echography (thickness of intima/media, IMT). To compare the evolution of left ventricular mass by echocardiography. To compare the development of proteinuria. To compare the safety profile by assessing the incidence of hypertension, hyperlipidemia, diabetes mellitus, infections and bone marrow toxicity. | — |
Countries
Belgium
Outcome results
None listed