A Cohort Study in Liver Transplant Patients Converted From a Tacrolimus Twice a Day (Prograf®) to Tacrolimus Once a Day (Advagraf®). French, Multisite, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®)
研究概览
简要总结
A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.
排除标准
- •Patient participating in an interventional clinical trial at the time of enrolment into the study.
研究组 & 干预措施
1:early conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® in the first 3 months after transplantation
干预措施: Tacrolimus (Drug)
2:late conversion from Prograf® to Advagraf®
patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Conversion ratio of the daily dose of tacrolimus (mg Prograf® / mg Advagraf®)
时间窗: At baseline
Percentage of patients with a conversion ratio of tacrolimus dose of 1mg/1mg and percentage of patients with a ratio differing from 1mg/1mg
Time of the first tacrolimus trough level (C0) after conversion
时间窗: From baseline to first determination of C0 (up to 6 months)
Number of days between the conversion date and the date of the first determination of C0 after conversion
Number of additional visits considered by the physicians to be due to the conversion (if required)
时间窗: At 6 months and at 1 year follow-up visit
Percentage of patients with additional visit(s) and percentage of patients without an additional visit
次要结局
- Reasons for conversion(At baseline)
- Patient profile(At baseline)
- Compliance with treatment at conversion(At baseline and at 1 year after conversion)
- Patients' quality of life at conversion(At baseline and at 1 year after conversion)
- Rate of acute rejection proven by biopsy (BPAR), graft survival rate and patient survival rate(6 months and 1 year)
- Occurrence of adverse events and/or effects(From baseline until 1 year follow-up visit)
- Time to reach steady state(From baseline to first determination of C0 (up to 6 months))
- Collection of immunosuppressive protocol details(At baseline, 6 months and 1 year follow-up visit)
- Dose ratio at steady state(From baseline and up to 6 months post-conversion)
- The Intra -Patient Variability (IPV) of tacrolimus in patients on Prograf® and Advagraf ®(At baseline (Prograf) and during the 45 days after conversion (Advagraf))
- Latest available laboratory data with Prograf® before conversion and with Advagraf®(At baseline, 6 months and 1 year follow-up visit)