Trial Information

Evaluating Safety and Efficacy of MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Combination With Low-Dose CsA, Tac or Sir in Comparison to Current Standard Immunosuppression (MMF, CsA and Corticosteroids) in Renal Tx

The purpose of the SYMPHONY study is to compare four different immunosuppressive regimens.
They are each given for one year. The following four combinations are tested in four groups
of patients:

- Group A: Cyclosporine in a normal dosage, mycophenolate mofetil (MMF) and
corticosteroids

- Group B: Daclizumab in the first two months after transplantation, cyclosporine in a
lower dosage compared to group A, mycophenolate mofetil (MMF) and corticosteroids

- Group C: Daclizumab in the first two months after transplantation, tacrolimus in low
dosage, mycophenolate mofetil (MMF) and corticosteroids

- Group D: Daclizumab in the first two months after transplantation, sirolimus in a low
dosage, mycophenolate mofetil (MMF) and corticosteroids.

All drugs of the four immunosuppressive regimes are approved by the Health Authorities in
the participating country for use in kidney transplantation. The regimen administered to the
patients in Group A represents a standard treatment, currently given with success to many
transplant patients in a number of countries in the world. The treatments in Groups B, C and
D are experimental in the sense that either the doses administered are lower than the ones
used before and/or the combination of drugs is experimental. Nevertheless, there are results
of scientific studies indicating that they are all effective alternatives and that they
might have advantages compared to the standard immunosuppressive regimen, in particular as
far as their safety (side effects, long-term toxicity) is concerned. However, from the
previous clinical experience, it is not yet clear which regimen offers the most advantages
for the patients. To find this out, in SYMPHONY the four regimens are administered to the
four groups of patients (A-D) and the results in the different groups will be compared.