Desensitization of Renal Transplant Candidates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- decrease in antibody reactivity
研究概览
简要总结
Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal transplantation.
详细描述
Pre-formed HLA antibodies prevent renal transplantation because of the risk of hyperacute rejection. We propose a prospective study evaluating the efficacy of Enteric Coated Mycophenolate Sodium (Myfortic) in decreasing the titers of anti-HLA alloantibodies in patients awaiting kidney transplantation. Myfortic is an immunosuppressant that inhibits the proliferation of B and T cells by blocking the enzyme inosine monophosphate dehydrogenase. We will attempt to determine whether a 6-week course of Myfortic adequately decreases the antibody reactivity to a level compatible with transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on the deceased donor kidney transplant waiting list with panel reactive antibodies >50% and living donor waiting list patients who have a history of a positive crossmatch (donor-specific antibodies) will be eligible for the study.
排除标准
- •Any subjects not meeting the Inclusion Criteria
- •Subjects unable to attend weekly clinic visits for six weeks
- •Inability to tolerate Myfortic
研究组 & 干预措施
Treatment
This is a single arm, interventional trial.
干预措施: Myfortic (Drug)
结局指标
主要结局
decrease in antibody reactivity
时间窗: six weeks
次要结局
- CBC and CMP values </> 2 times normal(six weeks)