An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 1
研究概览
简要总结
In experimental and clinical settings it has been shown that transplant tolerance is possible. It has been suggested that regulatory T cells play a beneficial role in the establishment of tolerance. Calcineurin inhibitors may inhibit development of regulatory T cells. However, the influence of calcineurin inhibitors on markers of transplant tolerance has not been studied in patients undergoing liver transplantation. Currently the investigators conduct a study to evaluate the safety and efficacy of a calcineurin inhibitor free immunosuppression in patients undergoing liver transplantation. In this study measurements of immune function and CD4+CD25high-Foxp3+-Il2/CD8+ status will also be performed. In parallel these measurements should be compared to a group of patients undergoing standard immunosuppression including calcineurin inhibitors.
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
- •Patients undergoing primary liver transplantation
- •Patients of age 18 years and older
- •Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation
排除标准
- •Multiple organ graft recipients
- •Patients receiving ABO incompatible grafts
- •Patients with positive cross match
- •Pregnancy
- •Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule
- •Patients under guardianship (e.g. individuals who are not able to freely give their informed consent)
研究者
Armin Goralczyk
Dr.
University Medical Center Goettingen