NCT00784966撤回1 期
Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.
研究概览
简要总结
The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.
排除标准
- •Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)
- •Active infections (clinically or by laboratory testing)
- •History of current malignancy or suspicion of malignancy until properly investigated and excluded
- •Liver or biliary abnormalities
- •Unstable cardiovascular disease
- •Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception
研究组 & 干预措施
1
Active Comparator
Two weeks etanercept post islet transplant
干预措施: etanercept (Drug)
2
Active Comparator
Two months etanercept treatment post islet transplant
干预措施: etanercept (Drug)
结局指标
主要结局
The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.
时间窗: Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.
次要结局
- Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control.(Outcome measures will be assessed at protocol prescribed intervals.)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Nitrite Infusion in Islet Cell TransplantationDiabetesNCT03544242University of Alabama at Birmingham4
Enrolling By Invitation
不适用
The Norwegian Pancreas Transplantation (PTx) StudyPancreas TransplantationAllograft RejectionSurgical Complication NecAllograft BiopsiesDiabetes MellitusNCT01957696Oslo University Hospital80
已完成
4 期
Anti-inflammatory Therapy to Improve Outcomes After TPIATPancreatitis, Chronic; Diabetes; TransplantNCT02713997University of Minnesota43
已完成
1 期
Pancreatic Islet Cell TransplantationType 1 DiabetesNCT00214786Baylor Research Institute4
已完成
1 期
Pancreatic Islet Cell Transplantation - A Novel Approach to Improve Islet Quality and EngraftmentIslet Cell TransplantationType 1 DiabetesNCT00530686Baylor Research Institute1