A Long-term Follow-up of Adult Kidney and Liver Allograft Recipients Previously Enrolled Into a Tacrolimus (Advagraf) Trial. A Multicentre Non-interventional Post Authorization Study (PAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,300
- 试验地点
- 145
- 主要终点
- Overall graft survival (time to graft loss)
研究概览
简要总结
The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.
详细描述
Prograf is one of the medications taken by a patient after they have had a liver or kidney transplant to prevent their body from rejecting the new liver or kidney transplant. Prograf is taken by the patient twice a day. Advagraf is a similar medication but is taken by the patient only once a day. There is some evidence emerging that may show that this once-a-day medication may show additional benefits over the twice a day medication, such as, patients more likely to remember to take this medication. Also, this once a day medication is slowly released in the body through the course of a day which in turn may provide better protection against the body rejecting the new transplanted organ over a longer period.
This study will follow up adult patients who were previously enrolled in an Advagraf trial after they have had a liver or kidney transplant. The information collected for this study will be information that the patient's doctor will normally collect when he/she sees the patient for their regular check-ups. Information will be collected once a year for a period of 5 years from when the patient received their new organ transplant. It is hoped that patient information collected during the study will provide prescribers with useful information in treatment of organ transplant patients.
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
- •Participated in one of the selected Astellas sponsored clinical trials :
- •DIAMOND - PMR-EC-1106
- •ADVANCE - PMR-EC-1211
- •ADHERE - PMR-EC-1212
- •Or, any potential new Astellas-sponsored Advagraf trial
- •Assigned to treatment with Advagraf in one of the selected Astellas sponsored clinical trials and received a kidney or liver organ transplant.
- •NOTE: The primary objective is to study long-term graft survival in patients currently or previously treated with Advagraf. Therefore patients do not have to be currently receiving Advagraf to be included, nor do they have to have completed a previous Astellas clinical trial.
排除标准
- •No exclusion criteria
研究组 & 干预措施
Organ transplant patients treated with Advagraf
To evaluate long-term graft survival in patients treated with Advagraf
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Overall graft survival (time to graft loss)
时间窗: Annually from date of transplant and for 5 five years
At each annual visit there will be a simple assessment to determine if the graft has survived or not.
次要结局
- Medical conditions of interest(Annually from date of transplant and for 5 five years)
- Emergence of de novo Donor Specific Antibody(Annually from date of transplant and for 5 five years)
- Immunosuppression regimen(Annually from date of transplant and for 5 five years)
- Overall patient survival(Annually from date of transplant and for 5 five years)
- Renal Function(Annually from date of transplant and for 5 five years)
- Biopsy proven acute rejection episodes(Annually from date of transplant and for 5 five years)
- Infections of interest(Annually from date of transplant and for 5 five years)