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临床试验/NL-OMON24720
NL-OMON24720已完成4 期

MOdifying Tacrolimus related TOxicity after liver transplantation (MOTTO). A randomized controlled trial comparing Envarsus® versus Advagraf® in de novo liver transplant recipients

Stichting Lever en Maag Darm onderzoek, Erasmus MC0 个研究点目标入组 106 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
106

研究概览

简要总结

Significantly less liver transplant recipients reached the composite primary endpoint at 12 months in the LCP-tacrolimus group compared to the extended-release tacrolimus group (50.9%, 95%-CI 37.9% - 63.9% versus 71.2%, 95%-CI 57.7% - 81.7%, p=0.005). This significant difference was observed both in the intention-to-treat and in the per protocol analysis. No differences in rejection rate, graft and patient survival were found. In conclusion, LCP-tacrolimus has a more favorable cardiovascular risk profile and results in less chronic kidney disease as compared to ER-tacrolimus in the first year after liver transplantation with comparable efficacy.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - First liver transplantation
  • - Age between 18 and 75

排除标准

  • - Pregnancy or breast feeding
  • - eGFR < 30 mL/min/1.73m2

研究者

发起方
Stichting Lever en Maag Darm onderzoek, Erasmus MC

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