NCT03147183已完成不适用
Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin
Maimónides Biomedical Research Institute of Córdoba1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年8月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- CMV-specific, CD8+ T-cell immunity
研究概览
简要总结
Renal transplant candidates who have CMV-specific, CD8+ T-cells, are CMV-seropositive and carry HLA-A1 and/ or HLA- A2 alleles have a high probability to maintain this type of immunity during the three first months after the transplant, despite induction immunosuppressive therapy (thymoglobulin).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant recipients with CMV-positive serology.
- •Patients with pre-transplant, CMV-specific CD8+ T cell-mediated immunity, i.e. IFNγ levels ≥0.2 UI/mL (QF-CMV Reactive).
- •Adults over 18 years of age.
- •Patients receiving induction therapy with thymoglobulin (at least a cumulative dosage of 1mg/kg).
- •Patients receiving prophylaxis with valganciclovir (900 mg/day, adjusted to kidney function) until day 90 after transplant.
- •Patients who signed an informed consent
排除标准
- •Multivisceral transplantation, including pancreas-kidney transplantation.
- •HIV infected patients.
- •Patients who cannot comply with the monitoring protocol.
研究组 & 干预措施
candidates for renal transplant
干预措施: Thymoglobulin (Drug)
结局指标
主要结局
CMV-specific, CD8+ T-cell immunity
时间窗: 18 months
Percentage of patients with CMV-specific, CD8+ T-cell immunity at any of the established time points for monitorization. "CMV-specific, CD8+ T-cell immunity" will be defined as production of IFNγ ≥0.2 UI/mL (QF-CMV Reactive).
次要结局
未报告次要终点
研究者
研究点 (1)
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