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https://hdl.handle.net/2440/86868
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Type: | Journal article |
Title: | The ORION study: comparison of two sirolimus-based regimens versus tacrolimus and mycophenolate mofetil in renal allograft recipients |
Author: | Flechner, S. Glyda, M. Cockfield, S. Grinyo, J. Legendre, C. Russ, G. Steinberg, S. Wissing, K. Tai, S. |
Citation: | American Journal of Transplantation, 2011; 11(8):1633-1644 |
Publisher: | Wiley |
Issue Date: | 2011 |
ISSN: | 1600-6135 1600-6143 |
Statement of Responsibility: | S. M. Flechner, M. Glyda, S. Cockfield, J. Grinyó, Ch. Legendre, G. Russ, S. Steinberg, K. M. Wissing and S. S. Tai |
Abstract: | Safety and efficacy of two sirolimus (SRL)-based regimens were compared with tacrolimus (TAC) and mycophenolate mofetil (MMF). Renal transplantation recipients were randomized to Group 1 (SRL+TAC; week 13 TAC elimination [n = 152]), Group 2 (SRL + MMF [n = 152]) or Group 3 (TAC + MMF [n = 139]). Group 2, with higher-than-expected biopsy-confirmed acute rejections (BCARs), was sponsor-terminated; therefore, Group 2 two-year data were limited. At 1 and 2 years, respectively, graft (Group 1: 92.8%, 88.5%; Group 2: 90.6%, 89.9%; Group 3: 96.2%, 95.4%) and patient (Group 1: 97.3%, 94.4%; Group 2: 95.2%, 94.5%; Group 3: 97.0%, 97.0%) survival rates were similar. One- and 2-year BCAR incidence was: Group 1, 15.2%, 17.4%; Group 2, 31.3%, 32.8%; Group 3, 8.2%, 12.3% (Group 2 vs. 3, p < 0.001). Mean 1- and 2-year modified intent-to-treat glomerular filtration rates (mL/min) were similar. Primary reason for discontinuation was adverse events (Group 1, 34.2%; Group 2, 33.6%; Group 3, 22.3%; p < 0.05). In Groups 1 and 2, delayed wound healing and hyperlipidemia were more frequent. One-year post hoc analysis of new-onset diabetes posttransplantation was greater in TAC recipients (Groups 1 and 3 vs. 2, 17% vs. 6%; p = 0.004). Between-group malignancy rates were similar. The SRL-based regimens were not associated with improved outcomes for kidney transplantation patients. |
Keywords: | Acute allograft rejection; delayed graft function (DGF); mycophenolate mofetil; renal function; sirolimus; tacrolimus |
Description: | Article first published online: 10 JUN 2011. Corrected by: Erratum Vol. 12, Issue 1, 268, Article first published online: 13 JAN 2012 |
Rights: | © 2011 The Authors |
DOI: | 10.1111/j.1600-6143.2011.03573.x |
Published version: | http://dx.doi.org/10.1111/j.1600-6143.2011.03573.x |
Appears in Collections: | Aurora harvest 7 Medicine publications |
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