Spots Global Cancer Trial Database for Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation

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.

Study ID: NCT00903188

Conditions

Renal Transplantation

Interventions

cyclosporine

Everolimus

Study Description

Brief 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.

Detailed 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