Renal Function, Efficacy, and Safety of Sirolimus and Mycophenolate Mofetil After Short-Term Calcineurin Inhibitor-Based Quadruple Therapy in De Novo Renal Transplant Patients: One-Year Analysis of a Randomized Multicenter Trial

医学 钙调神经磷酸酶 西罗莫司 肾功能 泌尿科 移植 霉酚酸 养生 内科学 不利影响 临床终点 霉酚酸酯 胃肠病学 肌酐 随机对照试验
作者
Markus Guba,Johann Pratschke,Christian Hugo,Bernhard K. Krämer,Constanze Nohr-Westphal,Jens Brockmann,Joachim Andrassy,Petra Reinke,Katharina Pressmar,Oliver W. Hakenberg,Michael Fischereder,Andreas Pascher,Wolf‐Dieter Illner,Bernhard Banas,Karl‐Walter Jauch
出处
期刊:Transplantation [Wolters Kluwer]
卷期号:90 (2): 175-183 被引量:102
标识
DOI:10.1097/tp.0b013e3181e11798
摘要

Background. De novo sirolimus in calcineurin inhibitor-free regimens, although potentially useful to improve early renal function, are complicated by various drug-related side effects. Methods. We report a prospective open-label, multicenter, randomized trial to evaluate early conversion from a CsA-based to a sirolimus (SRL)-based regimen 10 to 24 days after renal transplantation. Of the 196 patients, 141 patients with a low-to-moderate immunological risk were eligible to be converted to SRL or to continue CsA. All patients received antithymocyte globulin-F single-bolus induction, mycophenolate mofetil, and steroids. Results. The primary endpoint, renal function determined by S-creatinine and estimated glomerular filtration rate calculated by Nankivell formula at 12 months was significantly better in the SRL group (1.51±0.59 vs. 1.87±0.98 mg/dL or 64.5±25.2 vs. 53.4±18.0 mL/min/1.73 m2). Patient survival, graft survival, and incidence of biopsy-proven acute rejection after conversion were not statistically different. Drug discontinuations were significantly higher in the SRL group (36.2% vs. 19.7%). Significantly, more patients in the SRL group reported acne, aphtous, and temporary hyperlipidemia, whereas cytomegalovirus viremia was significantly decreased (7.3% vs. 28.2%). Conclusions. Early conversion to a calcineurin inhibitor-free regimen with SRL in combination with mycophenolate mofetil may be a useful strategy to improve renal function. The identification of appropriate candidates and safe management of SRL-related adverse events will be a key to avoid the high rate of dropouts, which currently limit the broad applicability of this protocol.
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