Multicentre, prospective, randomized, open-label, controlled study in de novo kidney transplant recipients to evaluate the impact of cyclosporine or steroid withdrawal at 3 months on graft function, patient and graft survival, and cardiovascular surrogate markers during the first five years after transplantation. - Cistcert
- Conditions
- Preservation of renal function after kidney transplantation in a 5-year, multicentre, prospective, randomized, open-label, controlled studyPatients 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.
- Registration Number
- EUCTR2007-005844-26-BE
- Lead Sponsor
- Antwerp University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?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
?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.
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