NL-OMON53377招募中3 期
*Randomized controlled prospEctiVe trial comparing extended-release with immediate-release tacrOlimus; reducing calcineurin inhibitor related toxicity in LUng TransplantatION patients* - revolution
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 145
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
- 年龄范围
- 18 至 64（—）
入选标准
- •For both the de novo and conversion study:
- •- Participant in Transplanlines biobank study UMCG
- •- Single or bilateral lung transplantation
- •- Age > 18 years
- •- On twice daily tacrolimus with stable trough levels in target range
- •- Written informed consent
- •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:
- •o At least one year after lung transplantation with a stable clinical course
- •o eGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula
排除标准
- •- Administration of mTOR inhibitors; everolimus, sirolimus
- •- Quadruple immunosuppression
- •- Also renal transplant recipient
- •Additional criteria for:
- •- Conversion study
- •o Expected survival < 3 years
研究者
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