NCT02417870终止1 期
Safety and Efficacy of Treatment With Ultra-low Dose Subcutaneous IL-2 to Promote Regulatory T Cells Post Renal Transplantation
Anil K. Chandraker, MD2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年9月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Increase in Treg Count
研究概览
简要总结
To investigate the safety and tolerability of treatment with low dose rIL-2 in renal transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipients
- •>18 years and <75 years of age
- •>6 months post Tx
- •on stable dose of immunosuppression
- •Transplant biopsy showing interstitial fibrosis and tubular atrophy of grade II or greater, with some evidence of lymphocytic infiltration (biopsy is NOT a study procedure, it would be performed as part of the patient's SOC)
- •Ability to give informed consent
排除标准
- •Biopsy proven acute cellular rejection; greater than grade 1A
- •Baseline creatinine >3.5mg/dL
- •Patients with active infection, including Hepatitis B and C, HIV
- •Current or prior invasive malignancy
- •Patients who are pregnant or breastfeeding
- •Patients who are unable to give consent
- •Prior intolerance of/allergy to IL2
- •Inability to comply with treatment
- •History of thrombotic angiopathy including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura
- •Symptomatic congestive cardiac failure or uncontrolled cardiac angina
- •Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
- •WOCBP and male subjects with reproductive potential must agree to use a highly effective method of birth control [defined in protocol & ICF] during study treatment, and for 6 months after completion of treatment.
结局指标
主要结局
Increase in Treg Count
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Anil K. Chandraker, MD
Medical Director of Kidney and Pancreas Transplantation
Brigham and Women's Hospital
研究点 (2)
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