Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients
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).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Efficacy of immunosuppression measured in rejection rate confirmed by biopsy according to BANFF 97, modified 2005.
one year after transplantation
Ulrich Hopt, Prof.Dr.Dr.
University Hospital Freiburg
Germany: Federal Institute for Drugs and Medical Devices