2024-518639-12-00招募中3 期
REVOLUTION; Randomized controlled trial comparing immediate versus extended release tacrolimus; reducing calcineurin inhibitor related toxicity in lung transplantation patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Kidney function
研究概览
简要总结
To compare absolute difference in renal function expressed as absolute difference in eGFR, at 2 years compared to baseline, calculated by the 2012 CKD-EPI creatinine–cystatin C equation in patients treated with IR or LCP tacrolimus.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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: o At least one year after lung transplantation with a stable clinical course and lung function o eGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula
排除标准
- •Administration of mTOR inhibitors; everolimus, sirolimus - Quadruple immunosuppression - Renal transplantation - The subject has any disease or condition that might interfere with completion of this study or reaching the primary endpoint (e.g., life expectancy of <3 years, renal replacement therapy at start study
结局指标
主要结局
Kidney function
Kidney function
次要结局
未报告次要终点
研究者
C.T.Gan
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
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