Disorder Related to Renal Transplantation Clinical Trial
Official title:
Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients
Current practice of immune suppressive standard therapy after renal transplantation in non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a concept of not using steroids in order to establish an immunosuppressive regimen in immunologically non-risk patients that is efficient and causes as few side effects as possible.
In this triple arm, prospectively randomized multi centre phase IV study 200 patients per
study arm will be investigated for 12 months.
Based on the results of the Symphony study the low dose tacrolimus study arm will be
modified to further improve efficacy (prevention of BPAR, best possible renal function) and
safety (adverse event profile regarding infections, cardiovascular risk factors, malignant
tumours) of immunosuppression. For this, CNI will be reduced and in addition the rate of
steroid free patients after 1 week will be maximized to achieve a long lasting improved post
surgical cardiovascular risk profile (in particular concerning de novo induction of diabetes
mellitus and other adverse events caused by steroids). Safety should be increased without
loss of efficacy of immunosuppression (measured in rejection rate and allograft loss rate)
as compared to an immune suppressive therapy comprising steroids. Therefore, following the
successful study arm of the Symphony study, immunosuppression in the first of the three
study arms comprises a steroid in combination with Advagraf and CellCept in addition to a
two dose induction therapy with Simulect (group A). The regimen of the second study arm is
similar but discontinues steroids on day seven after transplantation (group B). Therapy of
group three is similar to group B but Simulect is replaced by T-cell depleting polyclonal
antibodies (Thymoglobulin) (group C).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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