Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
- Registration Number
- NCT00903188
- Lead Sponsor
- University Hospital, Antwerp
- Brief Summary
This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events.
The primary objective: To assess if superior graft function (glomerular filtration rate (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-everolimus plus steroids compared to Myfortic-cyclosporine.
- Detailed Description
Methodology:
* A 5-year, multicentre, prospective, randomized, open-label, controlled study
* Group 1: Simulect + cyclosporine + Myfortic + steroid stop at 3 months
* Group 2: Simulect + cyclosporine (decrease dose in one week at month 3 and replace by everolimus) + Myfortic + steroid maintenance.
* In both groups MPA AUC monitoring will be done at 5-7 days and at 3 months, to ensure sufficient MPA protection.
Sample size calculations:
A total of 152 patients will be randomized (76 patients per group)
Population:
De novo kidney transplant recipients.
Study duration:
1.5 years inclusion+ follow-up during the first 5 years
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 152
- Male or female recipients of a de novo kidney transplant, aged above 18 years
- 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
- 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
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyclosporine cyclosporine Simulect + cyclosporine + Myfortic + steroid stop at 3 months Everolimus Everolimus Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance
- Primary Outcome Measures
Name Time Method 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-everolimus plus steroids compared to Myfortic-cyclosporine. 1 year
- Secondary Outcome Measures
Name Time Method To compare the evolution of graft function (estimated GFR by means of modified MDRD formula)during the first 5 years post transplantation. 5 years
Trial Locations
- Locations (5)
Erasme University Hospital
🇧🇪Brussels, Belgium
University Hospital, Ghent
🇧🇪Gent, Belgium
University Hospital Brussels
🇧🇪Brussels, Belgium
University Hospital of Liege
🇧🇪Liège, Belgium
University Hospital Antwerp
🇧🇪Edegem, Belgium