Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

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  • sponsor
    University Hospital, Antwerp
Updated on 7 November 2020
calcineurin inhibitor


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

Condition Renal transplant
Treatment cyclosporine, Everolimus
Clinical Study IdentifierNCT00903188
SponsorUniversity Hospital, Antwerp
Last Modified on7 November 2020


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