Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
9396072 | Transplantation Proceedings | 2005 | 4 Pages |
Abstract
A prospective, randomized trial evaluated the combination of everolimus of 1.5 or 3 mg/d with steroids, basiliximab, and low-dose cyclosporine (CsA) adjusted by C2 monitoring in 256 renal transplant recipients. CsA C2 target levels, initially set at 600 ng/mL, were tapered over time posttransplant. The median serum creatinine concentrations were 130 μmol/L in both sirolimus groups (1.5 and 3 mg/d) at 6 months. Biopsy-proven acute rejection (BPAR) occurred in 13.7% and 15.1% of patients in the 1.5 and 3 mg/d groups, respectively. The incidence of BPAR was significantly higher among patients with everolimus trough levels < 3 ng/mL. Posttransplant diabetes mellitus occurred rarely, and blood pressure control appeared favorable; however, serum cholesterol levels were increased by â¼50%, and serum triglycerides by â¼100%. Serum testosterone concentrations increased after renal transplantation in both everolimus groups. Concentration-controlled everolimus therapy combined with low-dose CsA provides effective protection against rejection with good renal function and safety profiles.
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Authors
B.K. Krämer, H.-H. Neumayer, R. Stahl, M. Pietrzyk, B. Krüger, B. Pfalzer, B. Bourbigot, S. Campbell, J. Whelchel, J. Eris, S. Vitko, K. Budde, RADA2307 Study Group RADA2307 Study Group,