French Multicentre Observational Study of a Prospective Cohort of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 578
- 试验地点
- 1
- 主要终点
- Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion
研究概览
简要总结
Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year.
Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-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
- •Renal transplant patient for less than one year
- •Patient where the conversion from Prograf® to Advagraf® has been decided by the doctor
排除标准
- •Patient participating in an interventional clinical trial at the time of inclusion
研究组 & 干预措施
1: early conversion from Prograf® to Advagraf®
patients converted during the first 6 months post-transplantation
干预措施: Tacrolimus (Drug)
2: late conversion from Prograf® to Advagraf®
patients converted between 6 and 12 months post-transplantation
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Time to measurement of the first trough tacrolimus blood concentration (C0) after conversion
时间窗: From baseline (conversion) to first determination of C0 assessed up to one year
number of days between the date of conversion and the date of first assay of C0 after conversion
Tacrolimus daily dose conversion ratio (mg Prograf® / mg Advagraf®)
时间窗: At baseline (i.e. time of conversion)
Percentage of patients with a tacrolimus dose conversion ratio of 1mg / 1mg and percentage of patients with a ratio ≠ 1mg / 1mg
Number of additional visits that the doctor considers to be due to the conversion (if applicable)
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 additional visit
次要结局
- Time to reach steady state(Time from baseline (conversion) to steady state C0 assessed up to one year)
- Dose ratio at steady state(At baseline (conversion) and up to 6 months post-baseline)
- Reasons for the conversion(At baseline)
- The intra-patient variability (IPV) of tacrolimus(At baseline and up to 6 months post-baseline)
- Incidence of biopsy proven acute rejections (BPAR) and survival of the graft and of the patient(At 1 year follow-up visit)
- Occurrence of adverse effects(From baseline until 1 year follow-up visit after baseline (conversion))
- Profile of the patients in both groups(At baseline)
- Latest available laboratory data with Prograf® before conversion and with Advagraf®(At baseline, 6 months and 1 year follow-up visit)
- Compliance with the treatment at conversion and at 1 year post-conversion(At baseline and 1 year follow-up visit)
- The quality of life of the patient at conversion and at 1 year post-conversion(At baseline and 1 year follow-up visit)