Chang-Kwon Oh; Jong Won Ha; Yeong Hoon Kim; Yong-Lim Kim; Yu Seun Kim

doi:10.4285/jkstn.2012.26.2.83

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Oh, Ha, Kim, Kim, and Kim: Safety and Efficacy of the Early Introduction of Everolimus (Certican®) with Low Dose of Cyclosporine in de Novo Kidney Recipients after 1 Month of Transplantation (Preliminary Results)

Original Article

The Journal of the Korean Society for Transplantation

The Journal of the Korean Society for Transplantation 2012; 26(2): 83-91.

Published online: 29 June 2012

DOI: https://doi.org/10.4285/jkstn.2012.26.2.83

Safety and Efficacy of the Early Introduction of Everolimus (Certican®) with Low Dose of Cyclosporine in de Novo Kidney Recipients after 1 Month of Transplantation (Preliminary Results)

Chang-Kwon Oh, M.D.¹, Jong Won Ha, M.D.², Yeong Hoon Kim, M.D.³, Yong-Lim Kim, M.D.⁴, Yu Seun Kim, M.D.⁵

¹Department of Surgery, Ajou University School of Medicine, Suwon, Korea.

²Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.

³Department of Nephrology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.

⁴Department of Nephrology, Kyungpook National University Hospital, Daegu, Korea.

⁵Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.

Corresponding author (yukim@yuhs.ac)

Received 16 October 2011 Accepted 19 March 2012

Abstract

Background

Everolimus and cyclosporine (CsA) exhibit synergistic immunosuppressive activity when used in combination. We analyzed preliminary data about the use of everolimus with a CsA-sparing strategy in de novo renal transplant recipients.

Methods

A comparative, parallel, randomized, open-label, 1 year study has been performed in 117 patients from 5 transplant centers to compare the efficacy and tolerability of everolimus (EVE)+reduced-dose CsA or enteric-coated mycophenolate sodium (Myfortic)+standard-dose CsA in combination with basiliximab and steroids. It ended on August 24, 2011. Efficacy failure (biopsy-proven acute rejection, death, graft loss, or loss to follow-up), safety, and renal function were evaluated at 1, 3, 5, and 12 months post-transplantation.

Results

Efficacy failure was comparable between the two groups. Only one graft loss has been reported in the control group and no patient death reported in either group. There was no significant difference in the incidence of biopsy-proven acute rejection until 3 and 5 month post-transplantation (P>0.05). The mean e-GFR of the group of EVE+reduced-dose CsA was significantly higher than that of the control group at 3 (65.6±16.9 mL/mim/1.73 m² vs. 56.7±14.4 mL/mim/1.73 m²; P=0.007) and 5 (68.6±18.8 mL/mim/1.73 m² vs. 58.1±16.2 mL/mim/1.73 m²; P=0.009) months. There was no significant difference in the incidence of discontinuations and serious adverse events between the groups (P>0.05).

Conclusions

The regimen of EVE+reduced-dose CsA seems to be tolerated well, with comparable efficacy failure and better renal function than enteric-coated mycophenolate sodium+standard-dose CsA.

Keywords: Kidney transplantation, Immunosuppression, Everolimus, Graft rejection

Figures and Tables

Fig. 1

The incidence of biopsy-proven acute rejection.

Fig. 2

Mean e-GFR by MDRD. Abbreviation: MDRD, modification of diet in renal disease.

Table 1

Demographic characteristic

Abbreviation: ESRD, end stage renal disease.

Table 2

Overall tolerability (adverse events)

Table 3

Comparative tolerability after 1 month post-transplantation

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