Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-Year observational results

Bernhard K. Krämer, Giuseppe Montagnino, Bernd Krüger, Raimund Margreiter, Christoph J. Olbricht, Roberto Marcen, Urban Sester, Ulrich Kunzendorf, Karl Heinz Dietl, Paolo Rigotti, Claudio Ronco, Silke Hörsch, Bernhard Banas, Ferdinand Mühlbacher, Manuel Arias

Research output: Contribution to journalArticle

Abstract

The European Tacrolimus versus Ciclosporin-A Microemulsion (CsA-ME) Renal Transplantation Study demonstrated that tacrolimus decreased acute rejection rates at 6 months. Primary endpoints of this investigator-initiated, observational 7-year follow-up study were acute rejection rates, patient and graft survival rates, and a composite endpoint (BPAR, graft loss, and patient death). We analyzed data from the original intent-to-treat population (n = 557; 286 tacrolimus, 271 CsA-ME). A total of 237 tacrolimus and 208 CsA-ME patients provided data. At 7 years, Kaplan-Meier estimated rates of patients free from BPAR were 77.1% in the tacrolimus arm and 59.9% in the CsA-ME arm, graft survival rates amounted to 82.6% and 80.6%, and patient survival rates to 89.9% and 88.1%. Estimated combined endpoint-free survival rates were 60.2% in the tacrolimus arm and 47.0% in the CsA-ME arm (P =

Original languageEnglish
Pages (from-to)307-314
Number of pages8
JournalTransplant International
Volume29
Issue number3
DOIs
Publication statusPublished - Mar 1 2016

Keywords

  • acute rejection
  • adverse events
  • calcineurin inhibitor
  • investigator-initiated study
  • long-term follow-up

ASJC Scopus subject areas

  • Transplantation

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    Krämer, B. K., Montagnino, G., Krüger, B., Margreiter, R., Olbricht, C. J., Marcen, R., Sester, U., Kunzendorf, U., Dietl, K. H., Rigotti, P., Ronco, C., Hörsch, S., Banas, B., Mühlbacher, F., & Arias, M. (2016). Efficacy and safety of tacrolimus compared with ciclosporin-A in renal transplantation: 7-Year observational results. Transplant International, 29(3), 307-314. https://doi.org/10.1111/tri.12716