An Open Label, Multi-centre, Prospective Study to Demonstrate Safety and Efficacy of Once Daily Advagraf in Patients Undergoing Kidney or Liver Transplantation in India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Renal function (evaluated by level of Serum Creatinine)
研究概览
简要总结
The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in adult population undergoing kidney or liver transplantation in India.
详细描述
This is a phase IV, multi-centre, open label prospective study of once daily Advagraf in 200 patients undergoing kidney or liver transplantation in India. Adult patients undergoing kidney or liver transplantation and meeting all other eligibility criteria will be enrolled in the study. Enrolled patients will be administered once daily dose of Advagraf for 12 weeks. During these 12 weeks a total of 9 regular visits will be undertaken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Transplantation
Advagraf
干预措施: Advagraf (Drug)
结局指标
主要结局
Renal function (evaluated by level of Serum Creatinine)
时间窗: from Day 0 to Week 12
Lipid profile
时间窗: 0, 4, and 12-week
Incidence of New-Onset Diabetes Mellitus After Transplant (NODAT)
时间窗: from Day 0 to Week 12
NODAT is defined as a composite endpoint consisting of first occurrence of one of 4 parameters: (1) Two fasting plasma glucose (FPG) levels \> 126 mg/dL which are \> 30 days apart. (2) Oral hypoglycemic agent use for \> 30 consecutive days. (3) Insulin therapy for \> 30 consecutive days and (4) HbA1c \> 6.5%
Incidence of infection
时间窗: from Day 0 to Week 12
For kidney transplant patients: Event rate of patients with biopsy-confirmed acute rejections (BCAR) ≥ Grade I according to -The Banff 2007 working classification of renal allograft pathology within the first 12 weeks following kidney transplantation
时间窗: from Day 0 to Week 12
The biopsy shall be performed prior to the initiation of any anti-rejection therapy and as soon as possible after the onset of clinical / laboratory signs indicative of possible rejection
For liver transplant patients: Event rate of patients with biopsy-confirmed acute rejections (BCAR) with Rejection Activity Index of ≥ 4, within the first 12 weeks following liver transplantation
时间窗: from Day 0 to Week 12
The biopsy shall be performed prior to the initiation of any anti-rejection therapy and as soon as possible after the onset of clinical / laboratory signs indicative of possible rejection. Biopsy-confirmed acute rejections (BCAR) with Rejection Activity Index was defined according to The 1997 Banff schema for grading liver allograft rejection
次要结局
- Incidence of corticosteroid resistant rejection(from Day 0 to Week 12)
- Time to first biopsy confirmed acute rejection episode(from Day 0 to Week 12)
- Incidence of corticosteroid sensitive rejection(from Day 0 to Week 12)
- Incidence of use of anti-lymphocyte antibodies(from Day 0 to Week 12)
- Overall frequency of acute rejection episodes(from Day 0 to Week 12)
- Severity of biopsy confirmed acute rejections(from Day 0 to Week 12)
- Graft loss(Week 12)
- Death(Week 12)