Guba, Markus and Pratschke, Johann and Hugo, Christian and Kraemer, Bernhard K. and Nohr-Westphal, Constanze and Brockmann, Jens and Andrassy, Joachim and Reinke, Petra and Pressmar, Katharina and Hakenberg, Oliver and Fischereder, Michael and Pascher, Andreas and Illner, Wolf-Dieter and Banas, Bernhard and Jauch, Karl-Walter (2010) 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. TRANSPLANTATION, 90 (2). pp. 175-183. ISSN 0041-1337, 1534-6080
Full text not available from this repository. (Request a copy)Abstract
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 m(2)). 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | EARLY CYCLOSPORINE WITHDRAWAL; KIDNEY-TRANSPLANTATION; ALLOGRAFT SURVIVAL; RECIPIENTS; IMMUNOSUPPRESSION; HISTOLOGY; REPLICATION; IMPROVEMENT; CONVERSION; REJECTION; Randomized clinical trial; Sirolimus; Kidney transplantation; Calcineurin inhibitor free immunosuppression |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 22 Jul 2020 06:32 |
| Last Modified: | 22 Jul 2020 06:32 |
| URI: | https://pred.uni-regensburg.de/id/eprint/24448 |
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