Surveillance Pharmacologique et Immunitaire précoce après Conversion au Belatacept Chez Les Patients Ayant Subi Une Transplantation rénale : étude Pilote
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Lymphocyte subpopulations in blood before freezing
研究概览
简要总结
Single-center, prospective, translational, clinical-biological, multidisciplinary study
详细描述
All patients starting belatacept will be informed about non-interventional study and will be included unless they do not accept (non-opposition, consent is not required). Patients will be included and followed up during the 6 first months, i.e. 9 infusions. Blood samples (3 heparinized tubes of 7ml + 1 dry tube without separator gel of 5ml, i.e. 26ml maximum per sample) and urine samples will be harvested before each perfusions and in case of rejection. Clinical and biological data will be collected in an electronic CRF.
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
- •Age ≥ 18 years
- •Renal transplant patient
- •Patient converted from an anticalcineurin to belatacept
排除标准
- •Opposition to data processing
- •Hemoglobin < 9g/dL
- •Patient under judicial protection
- •Pregnant or breastfeeding woman
结局指标
主要结局
Lymphocyte subpopulations in blood before freezing
时间窗: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing
时间窗: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.
时间窗: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.
时间窗: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
次要结局
- residual concentrations of belatacept(Month 6)