The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test
研究概览
简要总结
This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.
详细描述
All patients will receive methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin will be initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation in all patients and a total dose of 6-7.5mg/kg will be given over 3-5 doses. Steroids will be initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days and then patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De Novo, single Kidney recipient
- •At least 1 HLA mismatch
排除标准
- •Recipient of multiple organs
- •prior transplant recipient
- •Subjects who have Diabetes prior to transplant, as indicated by pre-transplant OGTT
- •PRA >10%
- •Hepatitis B surface antigen positive
- •Hepatitis C antibody positive
- •HIV positive
研究组 & 干预措施
1
All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol.
干预措施: Thymoglobulin (Drug)
结局指标
主要结局
Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test
时间窗: 6 months post transplant.
次要结局
- Incidence of acute rejection(6 months post transplant)