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- Titel:
Two corticosteroid-free regimens-tacrolimus monotherapy after basiliximab administration and tacrolimus/mycophenolate mofetil-in comparison with a standard triple regimen in renal transplantation: results of the Atlas study.
- Dokumenttyp:
- Journal Article; Multicenter Study; Randomized Controlled Trial; Article
- Autor(en):
- Vítko, S; Klinger, M; Salmela, K; Wlodarczyk, Z; Tyden, G; Senatorski, G; Ostrowski, M; Fauchald, P; Kokot, F; Stefoni, S; Perner, F; Claesson, K; Castagneto, M; Heemann, U; Carmellini, M; Squifflet, JP; Weber, M; Segoloni, G; Bäckman, L; Sperschneider, H; Krämer, BK
- Abstract:
- BACKGROUND: The side effects associated with corticosteroids have led to efforts to minimize their use in renal transplant patients. In this study we compared two corticosteroid-free tacrolimus-based regimens with a standard triple therapy. METHODS: This was a 6-month, phase III, open-label, parallel-group, multicenter study. The total analysis set comprised 451 patients, randomized (1:1:1) to receive tacrolimus (Tac) monotherapy following basiliximab (Bas) administration (n=153), Tac/mycophenolate mofetil (MMF) (n=151), or, Tac/MMF/corticosteroids triple therapy as a control (n=147). RESULTS: The study was completed by 91.2% (triple therapy), 94.7% (Tac/MMF), and 82.4% (Bas/Tac) of patients. Patient baseline characteristics were similar in all groups. The incidences of biopsy-proven acute rejection were 8.2% (triple therapy), 30.5% (Tac/MMF), and 26.1% (Bas/Tac), p<0.001 (multiple test for comparison with triple therapy); Bas/Tac vs. Tac/MMF, p=ns. The incidences of corticosteroid-resistant acute rejection were 2.0%, 4.0%, and 5.2%, p=ns. Graft survival (95.9%, 96.7%, and 94.7%, p=ns) and patient survival (100%, 99.3%, and 99.3%, p=ns) were similar in all groups. Median serum creatinine at month 6 was 123.0 micromol/L (triple therapy), 134.7 micromol/L (Tac/MMF) and 135.8 micromol/L (Bas/Tac). The overall safety profiles were similar; differences (p<0.05) were reported for anaemia (24.5% vs. 12.6% vs. 14.5%), diarrhoea (12.9% vs. 17.9% vs. 5.9%), and leukopenia (7.5% vs. 18.5% vs. 5.9%) for the triple therapy, Tac/MMF, and Bas/Tac group, respectively. The incidences of new-onset diabetes mellitus were 4.6%, 7.1%, and 1.4%, respectively. CONCLUSION: Corticosteroid-free immunosuppression was feasible with the Bas/Tac and the Tac/MMF regimens. Both corticosteroid-free regimens were equally effective in preventing acute rejection, with the Bas/Tac therapy offering some safety benefits.
- Zeitschriftentitel:
- Transplantation
- Jahr:
- 2005
- Band / Volume:
- 80
- Heft / Issue:
- 12
- Seitenangaben Beitrag:
- 1734-41
- Sprache:
- eng
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/16378069
- Print-ISSN:
- 0041-1337
- TUM Einrichtung:
- Fachgebiet Nephrologie (Prof. Heemann)
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