A randomized trial of everolimus and low-dose cyclosporine in renal transplantation

With or without steroids?

C. Ponticelli, M. Carmellini, G. Tisone, S. Sandrini, G. Segoloni, P. Rigotti, G. Colussi, S. Stefoni

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

This multicenter, randomized, prospective, controlled trial (EVIDENCE study) aimed to determine short-term effects of early steroid withdrawal in renal transplant patients initially treated with everolimus, low-dose cyclosporine (CsA), and steroids. Patients were randomized to standard triple therapy with CsA, everolimus twice daily and steroids (group A), steroid-free immunosuppression (group B), or triple therapy once daily (group C). However, since patient enrollment was slower than expected, group C randomization was prematurely discontinued. The primary end point was treatment failure rate (composite end point of death, graft loss, biopsy-proven acute rejection, and loss to follow-up) between randomization and month 12. Patients evaluable for the primary end point included 139 randomized patients. According to intention-to-treat analysis, 2.8% of patients in group A and 14.7% in group B experienced treatment failure (95% upper confidence limit 19.7%). As this was higher than the predefined noninferiority limit of 10%, noninferiority could not be proved. No conclusive statements can be made on noninferiority of the steroid withdrawal regimen vs the standard regimen in these patients. Additional studies with longer follow-up are required to determine the efficacy of steroidfree immunosuppression in renal transplant recipients receiving everolimus.

Original languageEnglish
Pages (from-to)3375-3382
Number of pages8
JournalTransplantation Proceedings
Volume46
Issue number10
DOIs
Publication statusPublished - 2014

Fingerprint

Kidney Transplantation
Cyclosporine
Steroids
Random Allocation
Treatment Failure
Immunosuppression
Transplants
Kidney
Intention to Treat Analysis
Everolimus
Randomized Controlled Trials
Biopsy
Therapeutics

ASJC Scopus subject areas

  • Surgery
  • Transplantation
  • Medicine(all)

Cite this

Ponticelli, C., Carmellini, M., Tisone, G., Sandrini, S., Segoloni, G., Rigotti, P., ... Stefoni, S. (2014). A randomized trial of everolimus and low-dose cyclosporine in renal transplantation: With or without steroids? Transplantation Proceedings, 46(10), 3375-3382. https://doi.org/10.1016/j.transproceed.2014.05.087

A randomized trial of everolimus and low-dose cyclosporine in renal transplantation : With or without steroids? / Ponticelli, C.; Carmellini, M.; Tisone, G.; Sandrini, S.; Segoloni, G.; Rigotti, P.; Colussi, G.; Stefoni, S.

In: Transplantation Proceedings, Vol. 46, No. 10, 2014, p. 3375-3382.

Research output: Contribution to journalArticle

Ponticelli, C, Carmellini, M, Tisone, G, Sandrini, S, Segoloni, G, Rigotti, P, Colussi, G & Stefoni, S 2014, 'A randomized trial of everolimus and low-dose cyclosporine in renal transplantation: With or without steroids?', Transplantation Proceedings, vol. 46, no. 10, pp. 3375-3382. https://doi.org/10.1016/j.transproceed.2014.05.087
Ponticelli, C. ; Carmellini, M. ; Tisone, G. ; Sandrini, S. ; Segoloni, G. ; Rigotti, P. ; Colussi, G. ; Stefoni, S. / A randomized trial of everolimus and low-dose cyclosporine in renal transplantation : With or without steroids?. In: Transplantation Proceedings. 2014 ; Vol. 46, No. 10. pp. 3375-3382.
@article{a20afbad33f44f18bad0d660065585fc,
title = "A randomized trial of everolimus and low-dose cyclosporine in renal transplantation: With or without steroids?",
abstract = "This multicenter, randomized, prospective, controlled trial (EVIDENCE study) aimed to determine short-term effects of early steroid withdrawal in renal transplant patients initially treated with everolimus, low-dose cyclosporine (CsA), and steroids. Patients were randomized to standard triple therapy with CsA, everolimus twice daily and steroids (group A), steroid-free immunosuppression (group B), or triple therapy once daily (group C). However, since patient enrollment was slower than expected, group C randomization was prematurely discontinued. The primary end point was treatment failure rate (composite end point of death, graft loss, biopsy-proven acute rejection, and loss to follow-up) between randomization and month 12. Patients evaluable for the primary end point included 139 randomized patients. According to intention-to-treat analysis, 2.8{\%} of patients in group A and 14.7{\%} in group B experienced treatment failure (95{\%} upper confidence limit 19.7{\%}). As this was higher than the predefined noninferiority limit of 10{\%}, noninferiority could not be proved. No conclusive statements can be made on noninferiority of the steroid withdrawal regimen vs the standard regimen in these patients. Additional studies with longer follow-up are required to determine the efficacy of steroidfree immunosuppression in renal transplant recipients receiving everolimus.",
author = "C. Ponticelli and M. Carmellini and G. Tisone and S. Sandrini and G. Segoloni and P. Rigotti and G. Colussi and S. Stefoni",
year = "2014",
doi = "10.1016/j.transproceed.2014.05.087",
language = "English",
volume = "46",
pages = "3375--3382",
journal = "Transplantation Proceedings",
issn = "0041-1345",
publisher = "Elsevier USA",
number = "10",

}

TY - JOUR

T1 - A randomized trial of everolimus and low-dose cyclosporine in renal transplantation

T2 - With or without steroids?

AU - Ponticelli, C.

AU - Carmellini, M.

AU - Tisone, G.

AU - Sandrini, S.

AU - Segoloni, G.

AU - Rigotti, P.

AU - Colussi, G.

AU - Stefoni, S.

PY - 2014

Y1 - 2014

N2 - This multicenter, randomized, prospective, controlled trial (EVIDENCE study) aimed to determine short-term effects of early steroid withdrawal in renal transplant patients initially treated with everolimus, low-dose cyclosporine (CsA), and steroids. Patients were randomized to standard triple therapy with CsA, everolimus twice daily and steroids (group A), steroid-free immunosuppression (group B), or triple therapy once daily (group C). However, since patient enrollment was slower than expected, group C randomization was prematurely discontinued. The primary end point was treatment failure rate (composite end point of death, graft loss, biopsy-proven acute rejection, and loss to follow-up) between randomization and month 12. Patients evaluable for the primary end point included 139 randomized patients. According to intention-to-treat analysis, 2.8% of patients in group A and 14.7% in group B experienced treatment failure (95% upper confidence limit 19.7%). As this was higher than the predefined noninferiority limit of 10%, noninferiority could not be proved. No conclusive statements can be made on noninferiority of the steroid withdrawal regimen vs the standard regimen in these patients. Additional studies with longer follow-up are required to determine the efficacy of steroidfree immunosuppression in renal transplant recipients receiving everolimus.

AB - This multicenter, randomized, prospective, controlled trial (EVIDENCE study) aimed to determine short-term effects of early steroid withdrawal in renal transplant patients initially treated with everolimus, low-dose cyclosporine (CsA), and steroids. Patients were randomized to standard triple therapy with CsA, everolimus twice daily and steroids (group A), steroid-free immunosuppression (group B), or triple therapy once daily (group C). However, since patient enrollment was slower than expected, group C randomization was prematurely discontinued. The primary end point was treatment failure rate (composite end point of death, graft loss, biopsy-proven acute rejection, and loss to follow-up) between randomization and month 12. Patients evaluable for the primary end point included 139 randomized patients. According to intention-to-treat analysis, 2.8% of patients in group A and 14.7% in group B experienced treatment failure (95% upper confidence limit 19.7%). As this was higher than the predefined noninferiority limit of 10%, noninferiority could not be proved. No conclusive statements can be made on noninferiority of the steroid withdrawal regimen vs the standard regimen in these patients. Additional studies with longer follow-up are required to determine the efficacy of steroidfree immunosuppression in renal transplant recipients receiving everolimus.

UR - http://www.scopus.com/inward/record.url?scp=84926381745&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84926381745&partnerID=8YFLogxK

U2 - 10.1016/j.transproceed.2014.05.087

DO - 10.1016/j.transproceed.2014.05.087

M3 - Article

VL - 46

SP - 3375

EP - 3382

JO - Transplantation Proceedings

JF - Transplantation Proceedings

SN - 0041-1345

IS - 10

ER -