Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

  • STATUS
    Recruiting
  • participants needed
    152
  • sponsor
    University Hospital, Antwerp
Updated on 7 November 2020
cyclosporine
calcineurin inhibitor
everolimus
myfortic

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.

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

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

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