NCT01371331已完成4 期
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 10
- 主要终点
- Determine AUCtau (area under the plasma concentration-time curve for a dosing interval)
研究概览
简要总结
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.
详细描述
The primary objective of this study is to determine the pharmacokinetics (PK) of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in paediatric subjects undergoing de novo allograft transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is the recipient of a solid organ (liver, kidney or heart) transplant. Multiorgan transplants are acceptable as long as one of the organs transplanted is liver, kidney or heart
排除标准
- •The subject has previously received another organ transplant (including liver, kidney or heart re-transplantation)
- •Subject has a high immunological risk, defined as a Panel Reactive Antibody (PRA) score >50% in the previous 6 months (only applicable for renal transplant recipients)
- •Cold ischemia time of the donor kidney greater than 30 hours (only applicable for renal transplant recipients)
- •Subject receives an AB0 incompatible donor organ
- •Subject has significant renal impairment, defined as having serum creatinine ≥230 μmol/l (≥2.6 mg/dl) pre-transplantation (not applicable for renal transplant recipients)
- •Subject has significant liver disease, defined as having elevated Alanine Aminotransferase (ALT) and/or Asparate Aminotransferase (AST) and/or Total Bilirubin levels 3 times the upper value of the normal range during the 28 days prior to transplantation (not applicable for liver transplant recipients)
- •Subject with pulmonary vascular resistance greater than 4 Wood units which is unresponsive to treatment
- •Subjects with malignancies or a history of malignancy within the last 5 years
- •Subject has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer
- •Subject requires systemic immunosuppressive medication for any indication other than transplantation
- •Recipient or donor known to be HIV, HCV or HBV positive
- •Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab or tacrolimus
- •Subject is currently participating in another clinical trial and/or has been taking an investigational drug in the 3 months prior to transplantation
- •Subject is unlikely to comply with the visits scheduled in the protocol
- •Subjects taking or requiring to be treated with medication or substances prohibited by this protocol
研究组 & 干预措施
Tacrolimus granules
Experimental
oral
干预措施: Tacrolimus granules (Drug)
结局指标
主要结局
Determine AUCtau (area under the plasma concentration-time curve for a dosing interval)
时间窗: on Day 1 and Day 7 (+/- 7 days)
Determine tmax (time to attain Cmax)
时间窗: on Day 1 and Day 7 (+/- 7 days)
Determine Ctrough (plasma concentration at the end of a dosing interval)
时间窗: on Day 1 and Day 7 (+/- 7 days)
Determine Cmax (maximum concentration)
时间窗: on Day 1 and Day 7 (+/- 7 days)
次要结局
- Graft survival(14 days)
- Patient survival(14 days)
- Rejection episodes(14 days)
- Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs(14 days)
研究者
研究点 (10)
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