A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Biopsy-proven acute rejection (BPAR)
研究概览
简要总结
This is a retrospective analysis of two different cohorts of patients that has undergone renal transplantation. This is a matched pair analysis of 100 patients treated with generic tacrolimus that will be compared with 100 matched controls treated with Prograf. Data will be obtained from patients' charts, from the Swedish National Kidney Registry and from a local registry at Transplantationscentrum. Patients included in the study are patients receiving a first single kidney transplant from a deceased or a living donor, treated with Prograf or Tacni and transplanted between transplanted January 2012 and August 2014. The 1-year-outcome of patients following renal transplantation, including BPAR, serious adverse effects and graft survival will be analysed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients receiving a first single kidney transplant from a deceased or a living donor.
- •Patients treated with Prograf or or generic tacrolimus
- •Patients transplanted between 1 October 2012 and 1 August 2014
排除标准
- •Multi-organ transplants
- •Re-transplantations
研究组 & 干预措施
Tacrolimus
100 patients treated with generic tacrolimus
干预措施: Generic tacrolimus (Drug)
Prograf
100 patients treated with Prograf
干预措施: Prograf (Drug)
结局指标
主要结局
Biopsy-proven acute rejection (BPAR)
时间窗: 1 year
Graft loss
时间窗: 1 year
Death
时间窗: 1 year
次要结局
- Compare the following parameters in the two groups • Graft survival at 6 and 12 months • BPAR at 6 and 12 months • Calculated GFR at 12 months(6 months, and 1 year)
- Compare serious adverse events at 12 months in the two groups(1 year)
- Compare the the cost of admissions for rejection treatment in the two groups(1 year)
- Tacrolimus dose at day of discharge(day of discharge, approx 7 days)
- Tacrolimus levels at day of discharge(day of discharge, approx 7 days)