Kidney transplantation without calcineurin inhibitors using sirolimus

Mark D Stegall, T. S. Larson, M. Prieto, J. Gloor, Stephen C Textor, Scott Nyberg, S. Sterioff, M. Ishitani, M. Griffin, Walter K Kremers, W. Lund, T. Schwab, Fernando G Cosio, J. Velosa

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Abstract

Introduction With the introduction of new immunosuppressive medicines, it has become possible to determine the extent to which nephrotoxic medicines contribute to CAN. The aim of this study is to compare the safety and efficacy of calcineurin inhibitor (CI) free immunosuppression in a prospective, randomized trial comparing sirolimus-mycophenolate mofetil (MMF)-prednisone to tacrolimus- MMF-prednisone. Methods Patients are randomized at the time of transplant to receive either tacrolimus (target level 12 to 15 ng/mL in the first month) or sirolimus (target level 12 to 18 ng/mL in the first month). All patients also receive MMF (750 mg bid) and prednisone tapered to 10 mg/d by 3 months and thymoglobulin induction (1.5 mg/kg/d on days 0, 1, 2, 4 and 6). Results At this point we have 4-month follow-up in 85 patients. The acute rejection rate is 7.5% (3/40) in the tacrolimus group and 6.7% (3/45) in the sirolimus group. We have discontinued sirolimus in eight patients so far, with wound complications being the most common indication. Renal function appears to be better in the sirolimus group at 1 month after transplantation, but the difference is not statistically significant. Conclusions While longer follow-up is needed, these results demonstrate that total avoidance of CI can be achieved with extremely low acute cellular rejection rates using sirolimus-based immunosuppression in combination with thymoglobulin, MMF, and prednisone.

Original languageEnglish (US)
JournalTransplantation Proceedings
Volume35
Issue number3 SUPPL.
DOIs
StatePublished - May 2003

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Sirolimus
Kidney Transplantation
Mycophenolic Acid
Prednisone
Tacrolimus
Immunosuppression
Immunosuppressive Agents
Calcineurin Inhibitors
Transplantation
Transplants
Kidney
Safety
Wounds and Injuries

ASJC Scopus subject areas

  • Surgery
  • Transplantation

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Kidney transplantation without calcineurin inhibitors using sirolimus. / Stegall, Mark D; Larson, T. S.; Prieto, M.; Gloor, J.; Textor, Stephen C; Nyberg, Scott; Sterioff, S.; Ishitani, M.; Griffin, M.; Kremers, Walter K; Lund, W.; Schwab, T.; Cosio, Fernando G; Velosa, J.

In: Transplantation Proceedings, Vol. 35, No. 3 SUPPL., 05.2003.

Research output: Contribution to journalArticle

Stegall, MD, Larson, TS, Prieto, M, Gloor, J, Textor, SC, Nyberg, S, Sterioff, S, Ishitani, M, Griffin, M, Kremers, WK, Lund, W, Schwab, T, Cosio, FG & Velosa, J 2003, 'Kidney transplantation without calcineurin inhibitors using sirolimus', Transplantation Proceedings, vol. 35, no. 3 SUPPL.. https://doi.org/10.1016/S0041-1345(03)00226-4
Stegall, Mark D ; Larson, T. S. ; Prieto, M. ; Gloor, J. ; Textor, Stephen C ; Nyberg, Scott ; Sterioff, S. ; Ishitani, M. ; Griffin, M. ; Kremers, Walter K ; Lund, W. ; Schwab, T. ; Cosio, Fernando G ; Velosa, J. / Kidney transplantation without calcineurin inhibitors using sirolimus. In: Transplantation Proceedings. 2003 ; Vol. 35, No. 3 SUPPL.
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AU - Larson, T. S.

AU - Prieto, M.

AU - Gloor, J.

AU - Textor, Stephen C

AU - Nyberg, Scott

AU - Sterioff, S.

AU - Ishitani, M.

AU - Griffin, M.

AU - Kremers, Walter K

AU - Lund, W.

AU - Schwab, T.

AU - Cosio, Fernando G

AU - Velosa, J.

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N2 - Introduction With the introduction of new immunosuppressive medicines, it has become possible to determine the extent to which nephrotoxic medicines contribute to CAN. The aim of this study is to compare the safety and efficacy of calcineurin inhibitor (CI) free immunosuppression in a prospective, randomized trial comparing sirolimus-mycophenolate mofetil (MMF)-prednisone to tacrolimus- MMF-prednisone. Methods Patients are randomized at the time of transplant to receive either tacrolimus (target level 12 to 15 ng/mL in the first month) or sirolimus (target level 12 to 18 ng/mL in the first month). All patients also receive MMF (750 mg bid) and prednisone tapered to 10 mg/d by 3 months and thymoglobulin induction (1.5 mg/kg/d on days 0, 1, 2, 4 and 6). Results At this point we have 4-month follow-up in 85 patients. The acute rejection rate is 7.5% (3/40) in the tacrolimus group and 6.7% (3/45) in the sirolimus group. We have discontinued sirolimus in eight patients so far, with wound complications being the most common indication. Renal function appears to be better in the sirolimus group at 1 month after transplantation, but the difference is not statistically significant. Conclusions While longer follow-up is needed, these results demonstrate that total avoidance of CI can be achieved with extremely low acute cellular rejection rates using sirolimus-based immunosuppression in combination with thymoglobulin, MMF, and prednisone.

AB - Introduction With the introduction of new immunosuppressive medicines, it has become possible to determine the extent to which nephrotoxic medicines contribute to CAN. The aim of this study is to compare the safety and efficacy of calcineurin inhibitor (CI) free immunosuppression in a prospective, randomized trial comparing sirolimus-mycophenolate mofetil (MMF)-prednisone to tacrolimus- MMF-prednisone. Methods Patients are randomized at the time of transplant to receive either tacrolimus (target level 12 to 15 ng/mL in the first month) or sirolimus (target level 12 to 18 ng/mL in the first month). All patients also receive MMF (750 mg bid) and prednisone tapered to 10 mg/d by 3 months and thymoglobulin induction (1.5 mg/kg/d on days 0, 1, 2, 4 and 6). Results At this point we have 4-month follow-up in 85 patients. The acute rejection rate is 7.5% (3/40) in the tacrolimus group and 6.7% (3/45) in the sirolimus group. We have discontinued sirolimus in eight patients so far, with wound complications being the most common indication. Renal function appears to be better in the sirolimus group at 1 month after transplantation, but the difference is not statistically significant. Conclusions While longer follow-up is needed, these results demonstrate that total avoidance of CI can be achieved with extremely low acute cellular rejection rates using sirolimus-based immunosuppression in combination with thymoglobulin, MMF, and prednisone.

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