Desensitization Protocol for Deceased Donor List
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Anti HLA antibody level
研究概览
简要总结
Purpose of the study:
The specific aims of this study are to evaluate overall efficacy and safety of the pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors affecting treatment outcomes in order to improve patient selection and treatment protocols for future patients.
详细描述
Background:
Intravenous immunoglobulin (IVIG) infusion is one of several novel approaches to decrease antibody levels for highly sensitized kidney transplant candidates [1, 2]. This approach can potentially give a chance of kidney transplantation to end-stage renal failure patients who could never receive transplantation because of high levels of antibodies and persistent positive crossmatches to all potential kidney donors. Many transplant centers have used this strategy in order to increase transplant rates of highly sensitized patients with various levels of anti-HLA antibodies. However, the responses to the treatment seem to be different in each patient and factors affecting treatment outcome have yet to be determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 7 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent (< 3 months) high levels of anti-HLA antibodies (at least one cPRA ≥ 40%).
- •Waiting time greater than 1 year for blood type AB, 2 years for blood types A, B, or O.
排除标准
- •Female subject is pregnant or lactating.
- •Subject has an uncontrolled concomitant infection or any other unstable medical condition (e.g., uncontrolled cardiovascular disease) that could interfere with the study objectives.
- •Subject has an uncontrolled active hepatitis B, hepatitis C, or HIV infection.
- •Subject has a current malignancy or a recent history of any malignancy that is deemed to be contraindicated to kidney transplantation.
- •Subject has a psychiatric illness that, in the judgment of caring physicians, may interfere with study participation.
结局指标
主要结局
Anti HLA antibody level
时间窗: after IVIG infusion
次要结局
- Number of patients transplanted(at the end of study)
研究者
Junichiro Sageshima
Associate Professor of Clinical
University of Miami