NCT00692562已完成1 期
Simultaneous Islet-Kidney Transplantation in Patients of Type 1 Diabetes With End-stage Renal Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Exogenous insulin requirement
研究概览
简要总结
The aim of this study was to evaluate the efficiency and safety of simultaneous islet-kidney transplantation in patients of type 1 diabetes with end-stage renal disease using a glucocorticoid-free immunosuppressive regimen with alemtuzumab induction. Islet transplantation can result in insulin independence with excellent metabolic control when glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet mass. Alemtuzumab (Campath-1H ®) is a 150-kDa humanized IgG1 monoclonal antibody that targets the CD52 antigen. Prolonged lymphocyte depletion can be expected following alemtuzumab treatment.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 18 to 60 years of age.
- •Ability to provide written informed consent.
- •Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(1999) on the Diagnosis and classification of Diabetes Mellitus.
- •manifest signs and symptoms that are severe enough to be incapacitating.
- •Basal C-peptide<0.5ng/mL
- •patients with poor diabetes control (HbA1c >7% but <12%)
- •progressive diabetic complications.
- •end-stage renal disease(serum creatinine>450μmol/l)
排除标准
- •age <18 years or >60 years
- •diabetic history <5 years
- •body weight >80kg
- •exogenous insulin requirement >1 unit/kg/day
- •severe anemia (male <8g/dl, female <7g/dl)
- •low white blood cell count (<3000/dl)
- •liver dysfunction
- •Symptomatic peptic ulcer disease
- •Any malignancy
- •Active infection including hepatitis B, hepatitis C, HIV, or TB
- •panel reactive antibody >20%
- •Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
结局指标
主要结局
Exogenous insulin requirement
时间窗: 5
kidney function
时间窗: 5
次要结局
- Hemoglobin A1c(5)
- Glucose and C-peptide levels(5)
- Portal vein Ultrasound(1)
- liver function(5)
- Complete Blood Count(5)
- autoantibodies(5)
研究者
研究点 (1)
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