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Low toxicity regimens in renal transplantation: a country subset analysis of the Symphony study

Demirbas, Alper; Hugo, Christian; Grinyo, Josep; Frei, Ulrich; Guerkan, Alp; Marcen, Roberto; Bernasconi, Corrado and Ekberg, Henrik LU (2009) In Transplant International 22(12). p.1172-1181
Abstract
P>Regional transplant practices may affect clinical outcomes within multinational studies. This study evaluated whether the overall results from the Symphony study can be generalized to the participating countries. De novo adult renal transplant recipients (n = 1645) were randomized to receive standard-dose cyclosporine, or daclizumab induction plus low-dose cyclosporine, low-dose tacrolimus, or low-dose sirolimus, all in addition to mycophenolate mofetil and steroids. Data for the highest patient-recruiting countries, Spain (n = 275), Germany (n = 316) and Turkey (n = 258), were compared. Patient transplant characteristics were different among the country subsets; only deceased donors in Spain, more expanded criteria donors in Germany,... (More)
P>Regional transplant practices may affect clinical outcomes within multinational studies. This study evaluated whether the overall results from the Symphony study can be generalized to the participating countries. De novo adult renal transplant recipients (n = 1645) were randomized to receive standard-dose cyclosporine, or daclizumab induction plus low-dose cyclosporine, low-dose tacrolimus, or low-dose sirolimus, all in addition to mycophenolate mofetil and steroids. Data for the highest patient-recruiting countries, Spain (n = 275), Germany (n = 316) and Turkey (n = 258), were compared. Patient transplant characteristics were different among the country subsets; only deceased donors in Spain, more expanded criteria donors in Germany, and mainly living donors in Turkey. Efficacy results for the three countries were consistent with that of the overall study - renal function and biopsy-proven acute rejection (BPAR) rates were superior with low-dose tacrolimus. Turkey had higher mean calculated glomerular filtration rate across all treatment groups (60.6-72.2 ml/min) compared with that of Spain (51.1-57.5 ml/min) and Germany (51.3-62.9 ml/min). Spain and Turkey had lower BPAR rates across the four treatment groups compared with the overall study; Germany had much higher rates (21.0-54.2%). These findings confirm the general applicability of the Symphony study results and highlight the importance of inclusion of patients from different geographic origins in randomized clinical trials. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
kidney transplantation, daclizumab, corticosteroids, cyclosporine, tacrolimus, sirolimus
in
Transplant International
volume
22
issue
12
pages
1172 - 1181
publisher
Springer
external identifiers
  • wos:000271251800007
  • scopus:70449112355
ISSN
1432-2277
DOI
10.1111/j.1432-2277.2009.00937.x
language
English
LU publication?
yes
id
89922e04-461c-4e4c-86d1-5864bdea2863 (old id 1504701)
date added to LUP
2009-11-25 10:12:38
date last changed
2017-11-12 03:36:15
@article{89922e04-461c-4e4c-86d1-5864bdea2863,
  abstract     = {P>Regional transplant practices may affect clinical outcomes within multinational studies. This study evaluated whether the overall results from the Symphony study can be generalized to the participating countries. De novo adult renal transplant recipients (n = 1645) were randomized to receive standard-dose cyclosporine, or daclizumab induction plus low-dose cyclosporine, low-dose tacrolimus, or low-dose sirolimus, all in addition to mycophenolate mofetil and steroids. Data for the highest patient-recruiting countries, Spain (n = 275), Germany (n = 316) and Turkey (n = 258), were compared. Patient transplant characteristics were different among the country subsets; only deceased donors in Spain, more expanded criteria donors in Germany, and mainly living donors in Turkey. Efficacy results for the three countries were consistent with that of the overall study - renal function and biopsy-proven acute rejection (BPAR) rates were superior with low-dose tacrolimus. Turkey had higher mean calculated glomerular filtration rate across all treatment groups (60.6-72.2 ml/min) compared with that of Spain (51.1-57.5 ml/min) and Germany (51.3-62.9 ml/min). Spain and Turkey had lower BPAR rates across the four treatment groups compared with the overall study; Germany had much higher rates (21.0-54.2%). These findings confirm the general applicability of the Symphony study results and highlight the importance of inclusion of patients from different geographic origins in randomized clinical trials.},
  author       = {Demirbas, Alper and Hugo, Christian and Grinyo, Josep and Frei, Ulrich and Guerkan, Alp and Marcen, Roberto and Bernasconi, Corrado and Ekberg, Henrik},
  issn         = {1432-2277},
  keyword      = {kidney transplantation,daclizumab,corticosteroids,cyclosporine,tacrolimus,sirolimus},
  language     = {eng},
  number       = {12},
  pages        = {1172--1181},
  publisher    = {Springer},
  series       = {Transplant International},
  title        = {Low toxicity regimens in renal transplantation: a country subset analysis of the Symphony study},
  url          = {http://dx.doi.org/10.1111/j.1432-2277.2009.00937.x},
  volume       = {22},
  year         = {2009},
}