De Novo Renal Transplant Recipient. Clinical Trial
Official title:
An Open, Prospective, Randomised, Controlled, Multi-Center Study Comparing Fixed Dose vs Concentration Controlled Mycophenolate Mofetil Regimens for de Novo Patients Following Transplantation
Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.
For treatment with mycophenolate mofetil the contribution of TDM still has to be determined,
although circumstantial evidence suggests the measurement of mycophenolic acid plasma
concentrations adds to patient management.
A concerted effort to test the hypothesis that TDM will improve outcome in mycophenolate
mofetil therapy in a prospective randomised trial is to be made if we want to have a solid
base for the continued measurements of mycophenolic acid concentrations in the future. This
trial aims to demonstrate the added value of TDM for mycophenolic acid, by comparing fixed
dose treatment with concentration controlled mycophenolate mofetil treatment in kidney
transplant recipients.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment