drugset / Trial / NCT00717470
A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
RandomizedParallel-groupOpen-labelPrevention
Summary
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
Timeline
- Start
- 2008-05-14
- Primary completion
- 2010-03-02
- Completion
- 2010-03-02
Publications
- Background Albano L, Banas B, Klempnauer JL, Glyda M, Viklicky O, Kamar N; Optimising immunoSuppression After Kidney transplantation with ADVAGRAF Study Group. OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation. Transplantation. 2013 Nov 27;96(10):897-903. doi: 10.1097/TP.0b013e3182a203bd.
- Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Basiliximab | Monoclonal antibody | — | Oral |
| Comparator | Tacrolimus | Small molecule | — | Oral |
| Comparator | Methylprednisolone | Other / unclassified | — | Oral |
| Comparator | Mycophenolate Mofetil | Small molecule | — | Oral |
| Comparator | Prednisone | Other / unclassified | — | Oral |
Indications
No indication recorded.