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Calcineurin Inhibitor Minimization in the Symphony Study: Observational Results 3 Years after Transplantation.

Ekberg, Henrik LU ; Bernasconi, C; Tedesco-Silva, H; Vítko, S; Hugo, C; Demirbas, A; Reyes Acevedo, R; Grinyó, J; Frei, U and Vanrenterghem, Y, et al. (2009) In American Journal of Transplantation 9. p.1876-1885
Abstract
The Symphony study showed that at 1 year posttransplant, a regimen based on daclizumab induction, 2 g mycophenolate mofetil (MMF), low-dose tacrolimus and steroids resulted in better renal function and lower acute rejection and graft loss rates compared with three other regimens: two with low-doses of cyclosporine or sirolimus instead of tacrolimus and one with no induction and standard cyclosporine dosage. This is an observational follow-up for 2 additional years with the same endpoints as the core study. Overall, 958 patients participated in the follow-up. During the study, many patients changed their immunosuppressive regimen (e.g. switched from sirolimus to tacrolimus), but the vast majority (95%) remained on MMF. During the follow-up,... (More)
The Symphony study showed that at 1 year posttransplant, a regimen based on daclizumab induction, 2 g mycophenolate mofetil (MMF), low-dose tacrolimus and steroids resulted in better renal function and lower acute rejection and graft loss rates compared with three other regimens: two with low-doses of cyclosporine or sirolimus instead of tacrolimus and one with no induction and standard cyclosporine dosage. This is an observational follow-up for 2 additional years with the same endpoints as the core study. Overall, 958 patients participated in the follow-up. During the study, many patients changed their immunosuppressive regimen (e.g. switched from sirolimus to tacrolimus), but the vast majority (95%) remained on MMF. During the follow-up, renal function remained stable (mean change: -0.6 ml/min), and rates of death, graft loss and acute rejection were low (all about 1% per year). The MMF and low-dose tacrolimus arm continued to have the highest GFR (68.6 +/- 23.8 ml/min vs. 65.9 +/- 26.2 ml/min in the standard-dose cyclosporine, 64.0 +/- 23.1 ml/min in the low-dose cyclosporine and 65.3 +/- 26.2 ml/min in the low-dose sirolimus arm), but the difference with the other arms was not significant (p = 0.17 in an overall test and 0.077, 0.039 and 0.11, respectively, in pair-wise tests). The MMF and low-dose tacrolimus arm also had the highest graft survival rate, but with reduced differences between groups over time, and the least acute rejection rate. In the Symphony study, the largest ever prospective study in de novo kidney transplantation, over 3 years, daclizumab induction, MMF, steroids and low-dose tacrolimus proved highly efficacious, without the negative effects on renal function commonly reported for standard CNI regimens. (Less)
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American Journal of Transplantation
volume
9
pages
1876 - 1885
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Wiley-Blackwell
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  • wos:000268050200025
  • pmid:19563339
  • scopus:67650938542
ISSN
1600-6135
DOI
10.1111/j.1600-6143.2009.02726.x
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English
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13ac1eec-6fa4-4afc-9e1d-507fb2f4366b (old id 1453535)
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http://www.ncbi.nlm.nih.gov/pubmed/19563339?dopt=Abstract
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2009-08-04 10:08:41
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@article{13ac1eec-6fa4-4afc-9e1d-507fb2f4366b,
  abstract     = {The Symphony study showed that at 1 year posttransplant, a regimen based on daclizumab induction, 2 g mycophenolate mofetil (MMF), low-dose tacrolimus and steroids resulted in better renal function and lower acute rejection and graft loss rates compared with three other regimens: two with low-doses of cyclosporine or sirolimus instead of tacrolimus and one with no induction and standard cyclosporine dosage. This is an observational follow-up for 2 additional years with the same endpoints as the core study. Overall, 958 patients participated in the follow-up. During the study, many patients changed their immunosuppressive regimen (e.g. switched from sirolimus to tacrolimus), but the vast majority (95%) remained on MMF. During the follow-up, renal function remained stable (mean change: -0.6 ml/min), and rates of death, graft loss and acute rejection were low (all about 1% per year). The MMF and low-dose tacrolimus arm continued to have the highest GFR (68.6 +/- 23.8 ml/min vs. 65.9 +/- 26.2 ml/min in the standard-dose cyclosporine, 64.0 +/- 23.1 ml/min in the low-dose cyclosporine and 65.3 +/- 26.2 ml/min in the low-dose sirolimus arm), but the difference with the other arms was not significant (p = 0.17 in an overall test and 0.077, 0.039 and 0.11, respectively, in pair-wise tests). The MMF and low-dose tacrolimus arm also had the highest graft survival rate, but with reduced differences between groups over time, and the least acute rejection rate. In the Symphony study, the largest ever prospective study in de novo kidney transplantation, over 3 years, daclizumab induction, MMF, steroids and low-dose tacrolimus proved highly efficacious, without the negative effects on renal function commonly reported for standard CNI regimens.},
  author       = {Ekberg, Henrik and Bernasconi, C and Tedesco-Silva, H and Vítko, S and Hugo, C and Demirbas, A and Reyes Acevedo, R and Grinyó, J and Frei, U and Vanrenterghem, Y and Daloze, P and Halloran, P},
  issn         = {1600-6135},
  language     = {eng},
  pages        = {1876--1885},
  publisher    = {Wiley-Blackwell},
  series       = {American Journal of Transplantation},
  title        = {Calcineurin Inhibitor Minimization in the Symphony Study: Observational Results 3 Years after Transplantation.},
  url          = {http://dx.doi.org/10.1111/j.1600-6143.2009.02726.x},
  volume       = {9},
  year         = {2009},
}