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Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00903188
Study type Interventional
Source University Hospital, Antwerp
Contact Jean-Louis Bosmans, MD/PhD
Phone +32/3/821 37 92
Email jeanlouis.bosmans@ua.ac.be
Status Recruiting
Phase Phase 4
Start date October 2008
Completion date April 2015

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