“De novo” renal transplantation
Conditions
Interventions
Trade Name: Myfortic 180 mg
Product Name: Myfortic
Pharmaceutical Form: Capsule*
INN or Proposed INN: sodium mycophenolate
Concentration number: 180-
Trade Name: Certican 0.25 mg
Product Name: certi
Sponsors
Hopital Erasme
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - First or second kidney transplantation - Males and females 18 years old or older - 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 (eg. Kidney-pancreas, kidney-heart, kidney-liver,…) - Transplantation of a patient who got another organ transplant previously - Recipients of HLA-identical living-related renal transplants - Patients with PRA > 30%, patients who have lost a first graft from rejection within two years after transplantation, and African European (black) patients. - Recipients of non-heart beating donor - 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 disorders 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 - History of malignancy in the past 5 years (with the exception of adequately treated basal or squamous skin cell carcinoma) - 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 compare two immunosuppressive regimens, one combining a calcineurin inhibitor (CsA) and an IMPDH inhibitor (Myfortic) with no steroids, with a combination of an IMPDH inhibitor (Myfortic), a m-TOR inhibitor (certican), and low-dose wteroids with no calcineurin inhibotir, on 1) graft function at 12 months; 2) long-term cardiovascular effects of the two treatment strategies; 3) rejection rates of the two treatment strategies.;Secondary Objective: -Frequency of biopsy proven acute rejection episodes -Incidence of clinical acute rejection episodes -Incidence of rejection treated by antibodies -Time to first rejection -Severity of rejection as assessed by BANFF 97 score -Number of acute rejections per patient -Plasma creatinine and calculated GFR -Proteinuria -Incidence and score of borderline changes and acute rejection -Incidence and score of chronic allograft changes -Graft survival -Patient survival -Development and evolution of glucose abnormalities -Use of insulin and oral anti-diabetics -Blood pressure at each study visit -Ambulatory 24-hrs. blood pressure monitoring -Left ventricular mass assessed by echocardiography -Fasting Lipid profile -Micro-CRP -Fasting Homocystein levels in plasma -Folic acid levels in plasma -Vitamin B12 levels in plasma -Plasma frozen samples for further analysis ;Primary end point(s): Graft function at 1 year as measured by calculated GFR | — |
Countries
Belgium
Outcome results
None listed