High rejection rates with low dose immunosuppression in old for old kidney transplantation

Markus Meier, Wibke Bode, Martin Nitschke, Waichi Wong, Michael G. Ison, Jan Kramer, Wolfram J. Jabs, Conny G. Bürk, Hendrik Lehnert, Lutz Fricke Prof.

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

Background: The aim of our one year prospective multicenter randomized controlled trial was to compare the effects of low dose tacrolimus (LD-Tac) and mycophenolate-mofetil (MMF) in elderly kidney transplant recipients (KTR) within the Eurotransplant Senior Program (ESP). Methods: Ninety kidney transplant recipients (KTR) were enrolled. All received baseline immunosuppression (IS) with daclizumab induction (2mg/kg), LD-Tac (trough level 5-8ng/ml), MMF (2g/d) and steroids. After three months, patients were randomized to receive either MMF (1-2g/d) and steroids or LD-Tac and steroids. Results: Of the 90 KTR enrolled, 38 patients (P) dropped out prior to randomization due to severe rejection (5P), intolerance of MMF dose (3P), out of target Tac level (3P), or other protocol violations (27P). Prior to randomization, delayed graft function occurred in 41%, and acute rejections in 58% of the KTR. Creatinine clearance in the MMF group was superior compared to the LD-Tac group after 6 months (p<0.05) and 12 months (p<0.05), whereas rejection and infection rates were not different. Conclusion: Unfortunately, the high dropout rate led to underpowerment of the study. However, the high incidence of early rejection demonstrates that low dose IS in this phase after transplantation is not sufficient for older patients. (ClinicalTrials.gov Identifier: NCT00912678).

Original languageEnglish (US)
Pages (from-to)118-126
Number of pages9
JournalTransplantationsmedizin: Organ der Deutschen Transplantationsgesellschaft
Volume23
Issue number2
StatePublished - Dec 1 2011

Keywords

  • Calcineurin inhibitor
  • European senior program
  • Kidney transplantation
  • Low dose tacrolimus
  • Old for old transplantation

ASJC Scopus subject areas

  • Transplantation

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    Meier, M., Bode, W., Nitschke, M., Wong, W., Ison, M. G., Kramer, J., Jabs, W. J., Bürk, C. G., Lehnert, H., & Fricke Prof., L. (2011). High rejection rates with low dose immunosuppression in old for old kidney transplantation. Transplantationsmedizin: Organ der Deutschen Transplantationsgesellschaft, 23(2), 118-126.