drugset / Trial / NCT00140543
European Trial of Immunosuppression in SPK Tx
Phase 3
Completed
228 enrolled
EUROSPK Study Group
Fujisawa GmbH · collabGenzyme, a Sanofi Company · collabHoffmann-La Roche · collabNeovii Biotech · collabWyeth is now a wholly owned subsidiary of Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2002-02
- Primary completion
- —
- Completion
- 2005-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | — | — |
| Subject | Sirolimus | Small molecule | — | — |