Everolimus with very low-exposure cyclosporine A in de Novo kidney transplantation: A multicenter, randomized, controlled trial

Maurizio Salvadori, Maria Piera Scolari, Elisabetta Bertoni, Franco Citterio, Paolo Rigotti, Maria Cossu, Antonio Dal Canton, Giuseppe Tisone, Alberto Albertazzi, Francesco Pisani, Giampiero Gubbiotti, Gianbenedetto Piredda, Ghil Busnach, Vito Sparacino, Volker Goepel, Piergiorgio Messa, Pasquale Berloco, Domenico Montanaro, Pierfrancesco Veroux, Stefano FedericoMarta Bartezaghi, Giuseppe Corbetta, Claudio Ponticelli

Research output: Contribution to journalArticle

Abstract

BACKGROUND: In combination with everolimus (EVL), cyclosporine A (CsA) may be used at low exposure, so reducing the risk of renal dysfunction in renal transplant recipients (RTR). We evaluated whether higher exposure of EVL could allow a further reduction of CsA. METHODS: De novo RTR were randomized to standard exposure EVL (C0 3-8 ng/mL) with low-concentration CsA (C2 maintenance levels 350-500 ng/mL, group A) or higher EVL exposure (C0 8-12 ng/mL) with very low-concentration CsA (C2 maintenance levels 150-300 ng/mL, group B). The primary endpoints were 6-month creatinine clearance (CrCl) and biopsy-proven acute rejection (BPAR) rate. After 6 months, patients were followed up (observational extension) to 12 months. RESULTS: Two hundred eighty-five RTR (97% from deceased donors) were enrolled. Two patients per group died (1.4%). The 6-month death-censored graft survival was 90.2% in group A and 97.9% in group B and was unchanged at 12 months (P=0.007). There was no significant difference between groups at 6 months in CrCl (59.9 vs. 57.8 mL/min) and BPAR rates (14.7% vs. 11.9%) and also at 12 months (CrCl 62.5±20.7 vs. 61.3±22.0 mL/min, BPAR 14.7% vs. 14.1%). No significant differences were seen in treated acute rejections, steroid-resistant acute rejections, treatment failures, or delayed graft function, although there was a trend to better results in group B. CONCLUSIONS: EVL given at higher exposure for 6 months plus very low CsA concentration may obtain low acute rejection rate and good graft survival in De novo renal transplantation. However, there was no difference between groups in CrCl.

Original languageEnglish
Pages (from-to)1194-1202
Number of pages9
JournalTransplantation
Volume88
Issue number10
DOIs
Publication statusPublished - Nov 2009

Keywords

  • Immunosuppression
  • Kidney transplantation
  • Randomized clinical trial.

ASJC Scopus subject areas

  • Transplantation

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    Salvadori, M., Scolari, M. P., Bertoni, E., Citterio, F., Rigotti, P., Cossu, M., Dal Canton, A., Tisone, G., Albertazzi, A., Pisani, F., Gubbiotti, G., Piredda, G., Busnach, G., Sparacino, V., Goepel, V., Messa, P., Berloco, P., Montanaro, D., Veroux, P., ... Ponticelli, C. (2009). Everolimus with very low-exposure cyclosporine A in de Novo kidney transplantation: A multicenter, randomized, controlled trial. Transplantation, 88(10), 1194-1202. https://doi.org/10.1097/TP.0b013e3181bb43ec