Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- EPO effects on Treg induction
研究概览
简要总结
The hypothesis of this proof-of-concept study is that EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. We also hypothesize that EPO will have a greater effect in everolimus vs. tacrolimus treated LTR, thus providing the rationale for a subsequent clinical trial to utilize EPO in combination with everolimus as a more successful pathway toward tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 18-74 years
- •History of liver transplantation > 2 years prior for non-immune causes
- •Use of immunosuppressive monotherapy (either tacrolimus or everolimus) for treatment of liver transplantation
- •Stable immunosuppression regimen at least 3 months prior to enrollment.
- •Ability to provide verbal and written informed consent
排除标准
- •• Hgb above average normal value (15.7 g/dL in men, 13.8 g/dL in women); ALT > 2 times upper limit of normal; uncontrolled hypertension with SBP>160 or DBP>100; end-stage renal disease on hemodialysis; history of venous thromboembolism including deep vein thromboses or pulmonary emboli, stroke, heart failure, seizure disorder, significant cardiovascular disease including a history of myocardial infarction, pure red cell aplasia, intolerance or allergy to erythropoietin; Active malignancy (untreated or undergoing therapy); known hypersensitivity to mammalian cell-derived products; known hypersensitivity to human albumin; presence of vascular access; prior recipient of erythropoietin within 12 weeks of the study; and pregnancy
- •Patient unable to provide consent including infants, children, teenagers, prisoners, cognitively impaired adults.
- •Prisoners and other vulnerable populations will also be excluded
研究组 & 干预措施
EPO Arm
干预措施: Erythropoietin (Drug)
结局指标
主要结局
EPO effects on Treg induction
时间窗: 12 weeks
We will use flow cytometry to analyze the phenotype of peripheral blood mononuclear cells (PBMC) collected before and 4 and 12 weeks after EPO administration. Data will be analyzed to extract changes in lymphocyte subset frequencies, including Tregs
次要结局
未报告次要终点
研究者
Josh Levitsky
Professor
Northwestern University