Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,430
- 试验地点
- 129
- 主要终点
- Change in renal function as measured by eGFR using the MDRD-4 formula
研究概览
简要总结
A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.
详细描述
This is a multicenter long-term (up to five years post-conversion), non-interventional registry in kidney transplant patients who have been converted from tacrolimus BD to Advagraf. Centers that are providing medical care for kidney transplant patients who may convert patients from tacrolimus BD to Advagraf will be identified and requested to approach patients for consent to participate.
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
- •Adult kidney transplant patients who are on tacrolimus BD and identified for conversion to Advagraf. Patients will only be approached about participating in the registry after their physician has made the decision to convert them to Advagraf. Patients previously treated with Advagraf and who have stopped for any reason will not be excluded from the registry provided that the physician has decided to convert.
排除标准
- •Patients currently taking Advagraf treatment
研究组 & 干预措施
Patients converted from tacrolimus BD to Advagraf
Oral
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Change in renal function as measured by eGFR using the MDRD-4 formula
时间窗: At transplantation, within 3 months after transplantation, up to 2 years pre-conversion and then every 6 months prior to conversion, at conversion (baseline), 12 months post-conversion and annually thereafter until EOS (up to 5 years post conversion)
Estimated Glomerular Filtration Rate (eGFR), Modification Diet in Renal Disease (MDRD-4), End of Study (EOS)
次要结局
- Overall patient survival(From transplantation to EOS (up to 5 years post conversion) or date of death from any cause)
- Tacrolimus trough level(From transplantation to EOS (up to 5 years post conversion))
- Change in renal function as measured by eGFR using the CKD-Epi formula(At transplantation, within 3 months after transplantation, up to 2 years pre-conversion and then every 6 months prior to conversion, at conversion (baseline), 12 months post-conversion and annually thereafter until EOS (up to 5 years post conversion))
- Incidence of BPAR episodes(From transplantation to EOS (up to 5 years post conversion))
- Time to first incidence of BPAR episodes(From transplantation to EOS (up to 5 years post conversion))
- Current immunosuppressant regimen(From transplantation to EOS (up to 5 years post conversion))
- Overall graft survival (time to graft loss)(From transplantation to date of graft loss)
- DSA status (de novo)(From transplantation to EOS (up to 5 years post conversion))
- Advagraf dose(From transplantation to EOS (up to 5 years post conversion))
- Status of treatment with Advagraf(From transplantation to EOS (up to 5 years post conversion))