Renal Transplantation Clinical Trial
Official title:
Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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