NCT01410162已完成4 期
A Randomized, Open Label, Cross Over Study to Examine the Impact of Prograf and Advagraf on Tacrolimus Exposure, Mycophenolic Acid Pharmacokinetics, Renal Allograft Function or Adverse Effects.
Norman Muirhead1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- renal function
研究概览
简要总结
Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Renal transplant or Renal Pancreas patients who are > 12 months post transplant
- •Stable allograft function defined as eGFR > 30-60ml/min
- •Renal patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months; Renal pancreas patients who have a stable tacrolimus trough level of 3-10 mg/ml in prior 3 months
- •Receiving concomitant therapy with mycophenolate mofetil in a dose of 500-1000mg bid or equivalent
排除标准
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- •Treated rejection within 3 months of randomization.
- •Increased serum creatinine > 20% within 3 months of randomization.
- •Subject is pregnant or breastfeeding
- •Subject has significant co-morbid disease (eg. Malignancy or uncontrolled infection) or disability (e.g. cognitive deficit) which prevents understanding of, or adherence to, the protocol
研究组 & 干预措施
Advagraf
Active Comparator
干预措施: Tacrolimus (Drug)
Prograf
Active Comparator
干预措施: Tacrolimus (Drug)
结局指标
主要结局
renal function
时间窗: baseline to 6 months
次要结局
- Bioequivalence of MPA exposure with Advagraf(Baseline, 12 weeks and 24 weeks)
研究者
Norman Muirhead
Professor, Medicine University of Western Ontario
Lawson Health Research Institute
研究点 (1)
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