Novel maintenance Immunosuppression
with Controlled systemic Exposure.

N/A

To compare the safety, efficacy, and impact on non-immune toxicity of AUC-controlled withdrawal of either cyclosporin (Neoral) or MMF (Cellcept) in stable renal transplant recipients currently on a triple maintenance regimen with Neoral, MMF, and steroids.

N/A

Randomized, controlled, prospective multicenter study in stable renal transplant recipients, at least 6 months post-transplantation, who receive maintenance immunosuppressive treatment with cyclosporine (Neoral) b.i.d., mycophenolate mofetil (MMF) 1 gram b.i.d., and steroids.
In elegible patients, systemic drug exposure (cyclosporine, MMF) will be measured by a 12-hours area under the time-blood concentration curve (AUC0-12) before randomization to one of the three study arms.
Patients will be randomized 1:1:1 with stratification for the occurrence of previous acute rejection episodes.

- Group A will continue on their current treatment regimen aiming at C2 levels of 700 ng/ml, (range: 600-800 ng/ml) In this group AUC-values will be blinded to the clinicians and evaluated retrospectively.

- In group B (MMF withdrawal) cyclosporine will be dosed to reach the defined target AUC0-12 of 3250 ng.h/ml (range 3000-3500 ng.h/ml).

- In group C (cyclosporine withdrawal) MMF will be given at a fixed dose of 1000 mg b.i.d at the start of the study period. After cessation of the cyclosporine AUC will be measured to adjust the dose to reach the defined MPA-AUC0-12 target of 75 mg.h/ml (range 60-90 ng.h/ml).
For safety reasons the minimal dose will be 500 mg b.i.d.