跳至主要内容
临床试验/NL-OMON29263
NL-OMON29263招募中不适用

‘Randomized controlled prospEctiVe trial comparing extended-release with immediate-release tacrOlimus; reducing calcineurin inhibitor related toxicity in LUng TransplantatION patients’

niversity Medical Center Groningen (UMCG)0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • For both the de novo and conversion study:
  • -Single or bilateral lung transplantation
  • -Age > 18 years
  • -On twice daily tacrolimus with stable trough levels in target range
  • -Written informed consent
  • -Participant in the TransplantLines biobank study in the UMCG
  • Additional criteria for:
  • -De novo study: De novo lung transplant patients are recruited before transplantation, and subsequently in all patients put on tacrolimus intravenously. Participants can be randomized when they are on stable daily dosage.
  • -Conversion study:
  • oAt least one year after lung transplantation with a stable clinical course, lung function and stable twice daily administered tacrolimus dosage for at least 3 months prior to conversion
  • oeGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula

排除标准

  • For both the de novo and conversion study:
  • --Administration of mTOR inhibitors; everolimus, sirolimus
  • -Quadruple immunosuppression
  • -Also renal transplant recipient
  • Additional criteria for:
  • -Conversion study
  • oExpected survival < 3 years

研究者

发起方
niversity Medical Center Groningen (UMCG)

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