Multi-center, open-label, prospective, randomized, parallel group study investigating an intensified Myfortic® dosing regimen in comparison to a standard dosing regimen of Myfortic® in combination with Sandimmun® Optoral and Corticosteroids in de novo renal transplant patients

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Extrait

This exploratory study will be conducted in two phases to compare in terms of safety and efficacy an initially intensified dosing regimen of Myfortic® versus a standard dosing regimen of Myfortic®. Primary objective of Phase I: Comparison of MPA exposure (AUC [0-12]) of two different Myfortic® dosing regimens including time to achieve an MPA AUC of > 40 mg*h/L. Primary objective of Phase II: To assess time to occurrence of treatment failures, defined as a composite endpoint of biopsy proven acute rejection, graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months post transplantation or at month 6 post transplantation.

Critère d'inclusion

De novo renal transplant recipients

Liens

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Multi-center, open-label, prospective, randomized, parallel group study investigating an intensified Myfortic® dosing regimen in comparison to a standard dosing regimen of Myfortic® in combination wit...