NCT00167661终止1 期
Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Incidence of Graft Rejection
研究概览
简要总结
The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.
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 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be a single-organ recipient (kidney only)
- •Participants who are receiving their first living donor or deceased donor transplant
排除标准
- •Participants who are recipients of HLA-identical living-donor renal transplants
- •Participants with a PRA value > 10% within 30 days prior to the transplant
- •Participants who have received a multi-organ transplant
- •Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV
- •Participants who have received an investigational drug within 6 weeks of study entry
- •Participants who have a previous history of, or who currently have, malignancies and/or lymphoma
- •Participants who have received corticosteroids within three months of transplantation
- •Participants who are 3rd transplant recipients
- •Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study
研究组 & 干预措施
Campath 1-H
Experimental
Campath 1-H
干预措施: Campath-1H (Drug)
结局指标
主要结局
Incidence of Graft Rejection
时间窗: at 1, 3, 6, 12, and 24 months
Participant Graft Survival
时间窗: at 6, 12, and 24 months
次要结局
- Number of Participants With Hypertension(up to 24 months)
- Number of Participants With Hyperlipidemia(up to 24 months)
- Participant Survival(at 6, 12, and 24 months)
- Number of Participants With Malignancy(up to 24 months)
- Number of Participant With Diabetes Mellitus(up to 24 months)
- Estimated Glomerular Filtration Rate (EGFR)(at 1, 6, 12 and 24 months)
- Number of Participants With Infection(up to 24 months)
- Growth Post-transplant Reported by Height Z Score(up to 24 months)
研究者
研究点 (1)
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