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Once-a-day regimen or Steroid withdrawal in de novo kidney transplant recipients treated with everolimus, cyclosporin and steroids: a 12-month, prospective, randomized, multicenter, open-label study. ...

Update Il y a 5 ans
Reference: EUCTR2008-007507-83

Once-a-day regimen or Steroid withdrawal in de novo kidney transplant recipients treated with everolimus, cyclosporin and steroids: a 12-month, prospective, randomized, multicenter, open-label study. The EVIDENCE study (EVerol/mus once-a-Day rEgimen with Neoral versus Corticosteroid Elimination)

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Extract

The primary objective of the study is to demonstrate, in renal transplant patients receiving everolimus and cyclosporin, the non-inferiority of one of the two following regimens: once-a-day regimen (Group A) OR steroid withdrawal regimen (Group B) in comparison with the standard twice-a-day regimen (Group C), using the treatment failure rate (composite endpoint of biopsy-proven acute rejection, graft loss, death or lost to follow-up) between randomization and Month 12 as primary endpoint.

Inclusion criteria

  • Recipients of a de novo kidney transplant

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