Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- allosensitization after complete islet graft loss
研究概览
简要总结
This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.
详细描述
After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus and tacrolimus) will be discontinued and they will be placed on Myfortic® monotherapy for 2 years thereafter. After completion of two years of Myfortic® maintenance monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve months, for the appearance of sensitization using panel reactive antibody (PRA) levels.
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
- •Male and female patients age 18-70 years of age.
- •Ability to provide written informed consent.
- •Mentally stable and able to comply with the procedures of the study protocol.
- •Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
- •History of at least one islet transplant.
- •Stimulated C-peptide <0.3 ng/ml.
排除标准
- •Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
- •For female participants: Positive pregnancy test or presently breast-feeding.
- •History of active infection including hepatitis B, hepatitis C, HIV, or TB.
- •Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
- •Known active alcohol or substance abuse.
- •Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction <30%.
- •History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.
- •Evidence of inter-current infection.
- •Active peptic ulcer disease
- •History on non-adherence to prescribed regimens including immunosuppression.
- •PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.
研究组 & 干预措施
Myfortic treatment
Treatment with Myfortic
干预措施: Myfortic (Drug)
结局指标
主要结局
allosensitization after complete islet graft loss
时间窗: 3 years
Allosensitization after complete islet graft loss after completion of two years of Myfortic® maintenance monotherapy.
次要结局
未报告次要终点
研究者
Rodolfo Alejandro
Professor of Medicine
University of Miami