1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based
immunosuppression (in conjunction with initial short-term steroids and polyclonal
antibody administration) in Type 1-diabetic patients undergoing simultaneous
pancreas/kidney allograft transplantation.
2. To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related
complications and overimmunosuppression-associated complications, particularly under
monitoring of the pharmacokinetic profile of all drugs administered.
Phase:
Phase 3
Details
Lead Sponsor:
EUROSPK Study Group
Collaborators:
Fujisawa GmbH Genzyme, a Sanofi Company Hoffmann-La Roche Neovii Biotech Wyeth is now a wholly owned subsidiary of Pfizer