MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of Allograft rejection
研究概览
简要总结
Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who have received a kidney transplant during the "MMF era"
- •Patients who have stable graft function indicated by a serum creatinine of < 1.8 mg/dl, or a calculated creatinine clearance of > 50 ml/minute
排除标准
- •Patients who have had > 1 rejection episode,
- •Patients who have had a rejection episode within the past year;
- •Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE
研究组 & 干预措施
2
Corticosteroid withdrawal / prednisone taper over 14 weeks
干预措施: Corticosteroid withdrawal (Drug)
结局指标
主要结局
Incidence of Allograft rejection
时间窗: 3 years
次要结局
- Renal function as determined by serum creatinine(measure after 36 months)
- Allograft Survival(3 years)
- Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)(Day 0 (pre-transplant))