NCT01332201已完成2 期
A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- determine steady state systemic exposure (AUC 0-24h)
研究概览
简要总结
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
- •negative pregnancy test prior to enrolment (females)
- •agree to practice effective birth control during the study
- •treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (<230 µmol/l (<2.6 ml/dl)) on Day 1
排除标准
- •receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
- •pulmonary vascular resistance ≥4 Wood units despite medication
- •required an emergency ventricular assist device within one week prior to transplantation
- •significant renal impairment
- •significant liver disease
- •malignancies or a history of malignancy within the last 5 years
- •significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer
- •requires systemic immunosuppressive medication for any other indication than transplantation
- •diagnosis of cystic fibrosis
- •pregnant or breast-feeding
研究组 & 干预措施
Advagraf
Experimental
干预措施: Advagraf (Drug)
Prograf
Active Comparator
干预措施: Prograf (Drug)
结局指标
主要结局
determine steady state systemic exposure (AUC 0-24h)
时间窗: Day 1, Day 3, Day 7 and Day 42
次要结局
- describe graft survival(up to 58 weeks)
- determine Cmax (maximum concentration)(Day 1, Day 3, Day 7 and Day 42)
- describe subject survival(up to 58 weeks)
- determine C24 (concentration prior to next morning dose)(Day 1, Day 3, Day 7 and Day 42)
- determine tmax (time to attain Cmax)(Day 1, Day 3, Day 7 and Day 42)
- describe rejection episodes(up to 58 weeks)
研究者
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Unknown
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