Randomized trial of early corticosteroid reduction vs. regular-dose corticosteroid maintenance in combination with tacrolimus and mycophenolate mofetil in living donor kidney transplant recipients: the Brazilian CORRETA trial.

Abstract:

:This multicenter, randomized trial aimed to compare the safety and efficacy of an early reduction in corticosteroid dose vs. long-term maintenance in Brazilian patients on an immunosuppressive regimen based on tacrolimus and mycophenolate mofetil (MMF). In the control arm, prednisone was progressively reduced from days 8 to 90 and then kept for 12 months. In the experimental arm, prednisone was given for 12 months at the dose of 5 mg every other day. Endpoints were the composite occurrence of death, graft loss, or Banff III acute rejection, and safety. A total of 83 patients were enrolled, and 77 were analyzed for efficacy safety. One death occurred in each group. There were no cases of graft loss and one case of grade 3 acute rejection in the early reduction arm. There was no difference in the rate of the composite primary endpoint between both arms (p=0.215), and there were no significant differences between both arms in terms of adverse events. Except for higher incidence of hypertriglyceridemia levels among patients in the regular-dose arm, there were no significant differences between both arms in terms of adverse events. The results of this trial suggest that early reduction of corticosteroid can be feasible and safe within a timeframe of 12 months in patients receiving tacrolimus and MMF.

journal_name

Clin Transplant

journal_title

Clinical transplantation

authors

Garcia VD,Carvalho DB,Gonçalves RT,Cavalcanti RL,Campos HH,Abbud-Filho M,Lobao-Neto AA

doi

10.1111/j.1399-0012.2009.01185.x

subject

Has Abstract

pub_date

2010-07-01 00:00:00

pages

E109-15

issue

4

eissn

0902-0063

issn

1399-0012

pii

CTR1185

journal_volume

24

pub_type

杂志文章,多中心研究,随机对照试验
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    pub_type: 杂志文章,随机对照试验

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    pub_type: 杂志文章

    doi:10.1111/ctr.12576

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    更新日期:2015-10-01 00:00:00

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    更新日期:2008-09-01 00:00:00