Comparison Thymoglobulin® Versus Grafalon® in Renal Transplantation - Spiesser Group (Retro/Prospective Study) I
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 13
- 主要终点
- Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database
研究概览
简要总结
This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.
Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.
详细描述
This is a prospective, multicenter, observational, non -interventional study with comparison with an historical cohort Investigators will compare the efficacy and safety of Thymoglobulin (Sanofi-Aventis) versus Grafalon (Neovii, previously ATG-Fresenius) in renal transplantation by evaluating patient survival, graft survival, delayed graft function, acute rejection, DSA occurrence and toxicities, various infections including CMV and BK virus incidence, MACE (major cardiac adverse event) and cancer.
Investigators will also compare cumulative treatment and follow up costs and other key criteria available in the ASTRE database.
Justification for a non-interventional study: in the study the medicinal products will be prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to the product is not decided in advance by a trial protocol but falls within current practice of the centre and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •For the Grafalon prospective group: all first 11-12 patients from the 13 transplant centres receiving Grafalon according to the local practice
- •For the Thymoglobulin group: a group of 130 patients matched for:
- •age (donor and recipient) gender indication (immunological indication versus DFG) CMV status
排除标准
- •Patient younger than 18 years old
- •Living donor
- •Donor after cardiac death (because the Maastricht 3 donors are authorized recently in France)
结局指标
主要结局
Comparison adverse events of the 2 ATGs and data collected thanks to the ASTRE database
时间窗: During one year
All events: Death, graft loss, acute rejection, DGF, de novo DSA Severe infection (SAE), hematological adverse event (SAE), CMV infection, BK virus infection, MACE(major cardiac adverse event) and cancer
次要结局
- Cost comparison(During one year)
- Recipient Efficacy (any adverse events)(During one year)
- Recipient Safety (any adverse events)(During one year)
- Reconstitution of the T, and B cell populations(During one year)