NCT00475059已完成不适用
Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine
研究概览
简要总结
Among the different creatinine-based GFR predicting equations, the MDRD equation gives the best prediction in renal transplantation but does not provide the level of accuracy usually seen in renal patients with native kidneys.
Blocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR.
We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal transplant patients by incorporating into the equation a cimetidine-corrected serum creatinine value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplantation > 1 year
- •Patient with immunosuppressant treatment of TACROLIMUS (PROGRAF)
- •Creatinine clearance > 30 ml/min/1,73m2 within 3 months before inclusion
- •Written informed consent
- •Patient affiliated to social insurance
排除标准
- •Unstable renal function defined by serum creatinine (J0) > 25% serum creatinine realised in 3 months
- •Treatment: Bactrim, Fansidar, Cimetidine arrow within the week before inclusion
- •Contraindication listed in the labeling of Cimetidine arrow
- •Last residual rate of Tacrolimus > 12 ng/ml.
- •Treatment : carvedilol, phenytoïn (interaction with cimetidine)
- •Serious hepatic insufficiency
研究组 & 干预措施
1
Experimental
patients who received cimétidine
干预措施: cimetidine arrow (Drug)
结局指标
主要结局
performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine
时间窗: two days
次要结局
- Performance of different prediction equations for estimating renal function with or no block of secretion renal tubule with cimetidine : - Walser equation - Nankivell equation - Cockcroft and Gault equation(two days)
- comparison between inulin clearance and cystatin C(two days)
研究者
研究点 (1)
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