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Cyclosporine Sparing with Mycophenolate Mofetil, Daclizumab and Corticosteroids in Renal Allograft Recipients: The CAESAR Study.

Ekberg, Henrik LU ; Grinyó, J; Nashan, B; Vanrenterghem, Y; Vincenti, F; Voulgari, A; Truman, M; Nasmyth-Miller, C and Rashford, M (2007) In American Journal of Transplantation 7(3). p.560-570
Abstract
Although the calcineurin inhibitors (CNI) cyclosporine (CsA) and tacrolimus are highly effective immunosuppressants, they are associated with serious side effects. There is great interest in immunosuppressive regimens that permit reduction or elimination of CNIs, while maintaining adequate immunosuppression and acceptable acute rejection rates. Patients (n = 536) receiving their first renal allograft were randomized to one of three immunosuppressant regimens: daclizumab, mycophenolate mofetil (MMF), corticosteroids (CS) and low-dose CsA (target trough levels of 50–100 ng/mL), weaned from month 4 and withdrawn by month 6; daclizumab, MMF, CS and low-dose CsA; or MMF, CS and standard-dose CsA. Mean GFR 12 months after transplantation... (More)
Although the calcineurin inhibitors (CNI) cyclosporine (CsA) and tacrolimus are highly effective immunosuppressants, they are associated with serious side effects. There is great interest in immunosuppressive regimens that permit reduction or elimination of CNIs, while maintaining adequate immunosuppression and acceptable acute rejection rates. Patients (n = 536) receiving their first renal allograft were randomized to one of three immunosuppressant regimens: daclizumab, mycophenolate mofetil (MMF), corticosteroids (CS) and low-dose CsA (target trough levels of 50–100 ng/mL), weaned from month 4 and withdrawn by month 6; daclizumab, MMF, CS and low-dose CsA; or MMF, CS and standard-dose CsA. Mean GFR 12 months after transplantation (primary end point) was not statistically different in the CsA withdrawal and low-dose CsA groups (both 50.9 mL/min/1.73 m2) vs. the standard-dose CsA group (48.6 mL/min/1.73 m2). At 12 months, the incidence of biopsy-proven acute rejection was significantly higher in the CsA withdrawal group (38%) vs. the low- or standard-dose CsA groups (25.4% and 27.5%, respectively; p < 0.05). In summary, a regimen of continuous low-dose CsA with MMF, CS and daclizumab induction is a clinically safe and effective immunosuppressive regimen in renal transplant recipients. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Calcineurin inhibitor, Kidney transplantation, nephrotoxicity, renal function, sparing, withdrawal
in
American Journal of Transplantation
volume
7
issue
3
pages
560 - 570
publisher
Wiley-Blackwell
external identifiers
  • wos:000244715800011
  • scopus:33847765065
ISSN
1600-6135
DOI
10.1111/j.1600-6143.2006.01645.x
language
English
LU publication?
yes
id
ed43801e-f893-47b3-96a7-3e1f2b0ee3c4 (old id 164831)
date added to LUP
2007-07-18 09:43:33
date last changed
2017-11-12 03:26:58
@article{ed43801e-f893-47b3-96a7-3e1f2b0ee3c4,
  abstract     = {Although the calcineurin inhibitors (CNI) cyclosporine (CsA) and tacrolimus are highly effective immunosuppressants, they are associated with serious side effects. There is great interest in immunosuppressive regimens that permit reduction or elimination of CNIs, while maintaining adequate immunosuppression and acceptable acute rejection rates. Patients (n = 536) receiving their first renal allograft were randomized to one of three immunosuppressant regimens: daclizumab, mycophenolate mofetil (MMF), corticosteroids (CS) and low-dose CsA (target trough levels of 50–100 ng/mL), weaned from month 4 and withdrawn by month 6; daclizumab, MMF, CS and low-dose CsA; or MMF, CS and standard-dose CsA. Mean GFR 12 months after transplantation (primary end point) was not statistically different in the CsA withdrawal and low-dose CsA groups (both 50.9 mL/min/1.73 m2) vs. the standard-dose CsA group (48.6 mL/min/1.73 m2). At 12 months, the incidence of biopsy-proven acute rejection was significantly higher in the CsA withdrawal group (38%) vs. the low- or standard-dose CsA groups (25.4% and 27.5%, respectively; p &lt; 0.05). In summary, a regimen of continuous low-dose CsA with MMF, CS and daclizumab induction is a clinically safe and effective immunosuppressive regimen in renal transplant recipients.},
  author       = {Ekberg, Henrik and Grinyó, J and Nashan, B and Vanrenterghem, Y and Vincenti, F and Voulgari, A and Truman, M and Nasmyth-Miller, C and Rashford, M},
  issn         = {1600-6135},
  keyword      = {Calcineurin inhibitor,Kidney transplantation,nephrotoxicity,renal function,sparing,withdrawal},
  language     = {eng},
  number       = {3},
  pages        = {560--570},
  publisher    = {Wiley-Blackwell},
  series       = {American Journal of Transplantation},
  title        = {Cyclosporine Sparing with Mycophenolate Mofetil, Daclizumab and Corticosteroids in Renal Allograft Recipients: The CAESAR Study.},
  url          = {http://dx.doi.org/10.1111/j.1600-6143.2006.01645.x},
  volume       = {7},
  year         = {2007},
}