Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
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- STATUS
- Recruiting
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- participants needed
- 152
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- sponsor
- University Hospital, Antwerp
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 Identifier | NCT00903188 |
| Sponsor | University Hospital, Antwerp |
| Last Modified on | 7 November 2020 |
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