NCT00798785Unknown1 期
Long-term Function of Beta Cell Allografts in Non-uremic Type 1 Diabetic Patients
AZ-VUB4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Evidence of clinically relevant beta cell graft function
研究概览
简要总结
The present proof of concept study addresses the following specific aims:
The general objectives of this work are:
- To increase and maintain the functional beta-cell mass after islet transplantation under a condition of low-dose tacrolimus
- To co-investigate the potential of alternative sites for encapsulated beta-cells
详细描述
- Aim 1: To increase functional beta cell mass by adding rituximab at first implantation
- Aim 2: To increase functional beta cell mass by adding basilixumab at second implantation
- Aim 3: To assess the influence of down-tapering the tacrolimus dose during posttransplant years 2-5 on these data, on metabolic control, on the prevalence of hypoglycemia and on safety parameters.
- Aim 4: To investigate the potential of the peritoneum and omentum as an alternative site for encapsulated beta-cells.
- Aim 5: To investigate the potential of the brachioradial muscle as an alternative site for encapsulated beta-cells.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years, male or female, Caucasian or not; only subjects < 50 yrs will be allocated to the rituximab treatment arm
- •Body weight < 100 kg; patients with a bodyweight of < 80kg, will receive priority
- •Patients with a BMI ≤ 27 kg/m2 will receive priority
- •Type 1 insulin-dependent diabetes
- •C-peptide < 0.07 nmol/l (<0.2 µg/l) 6 min. after glucagon IV (1mg) (glycemia > 180 mg/dl)
- •Intensive insulin therapy for more than two years, patients with insulin pump during at least 2 months before inclusion will receive priority
- •Patients should have at least one of the following chronic complications of diabetes:
- •Plasma creatinine <2 mg/dl and albuminuria 30-1000 mg/ 24hrs on 3 separate determinations (>1 month) outside an episode of illness, despite intake of ACE inhibitors; mean systolic blood pressure should be under 130 mmHg and mean diastolic blood pressure under 85 mmHg, when measured at home with ambulatory BP monitoring
- •Moderate or severe non-proliferative or proliferative retinopathy
- •Hypoglycemic unawareness
- •Cooperative and reliable patient giving informed consent by signature
排除标准
- •EBV antibody negativity
- •HIV 1 & 2 antibody positivity
- •CMV IgM positivity
- •Plasma creatinine ≥ 2 mg/dl and/or albuminuria ≥1000 mg/24 hrs
- •History of thrombosis or pulmonary embolism
- •History of malignancy, tuberculosis or chronic viral hepatitis
- •History of any other serious illness which could be relevant for the protocol
- •Presence of HLA antibodies
- •Blood donation within one month prior to screening or during the study
- •Symptoms and/or signs of infection, particularly (present or past) endocarditis, osteomyelitis, past tuberculosis with requirement for therapy
- •Any history of hepatic or neoplastic disease
- •Any history of renal disease (except diabetes)
- •Abnormal liver function tests and /or NMR of liver
- •Hemoglobinopathy
- •History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
- •Pregnancy or use of inadequate contraception by female patients of childbearing potential
- •Use of illicit drugs or overconsumption of alcohol (> 3 beers/day) or history of drug or alcohol abuse
- •Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders
- •Having received antidepressant medications during the last 6 months
- •Having participated the last 12 months or participating in another clinical study
研究组 & 干预措施
group I ATG-MMF-TAC
Experimental
Two clinical implants in the liver:
First implant: ATG-fresenium Maintained immunosuppression: MMF-TAC n=30
干预措施: ATG-MMF-TAC (Drug)
group II ATG-Rituximab-MMF-TAC
Experimental
Two clinical implants in the liver:
First Implant: ATG fresenium + Rituximab Maintained immunosuppression: MMF-TAC n=5
干预措施: ATG-Rituximab-MMF-TAC (Drug)
group III ATG-Basilixumab-MMF-TAC
Experimental
Two clinical implants in the liver:
First implant: ATG-fresenium Second implant: basilixumab Maintained immunosuppression: MMF-TAC n=5
干预措施: ATG-basilixumab-MMF-TAC (Drug)
group IV omentum
Experimental
Two clinical implants: first in the omentum followed by a clinical implant in the liver:
First implant: ATG-fresenium Maintained immunosuppression: MMF-TAC n=10
干预措施: omentum (Procedure)
结局指标
主要结局
Evidence of clinically relevant beta cell graft function
时间窗: up to 60 months
次要结局
未报告次要终点
研究者
Bart Keymeulen
UZ Brussels
AZ-VUB
研究点 (4)
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