Impact of the Microbiota on the Likelihood of Renal Graft Rejection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 19
- 主要终点
- Acute rejection occurence
研究概览
简要总结
Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.
详细描述
Gut microbiota as well as the signature of the 16S plasma bacterial DNA and bacterial metabolites of patients on the date of transplantation and during the first year after transplantation will be analyzed. The phenotype of the patients' T lymphocytes will be analyzed at the same time. These data will be correlated with the occurrence of acute cell rejection during the first year of transplantation
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients called for a kidney transplant
- •Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids
- •Patient having signed the informed consent
排除标准
- •Multiple grafts combined or sequential
- •Induction therapy with polyclonal antibodies
- •HIV or active viral infection such as hepatitis B or C
- •Active bacterial infection
- •Pregnancy or breastfeeding at time of inclusion
- •Patient unable to express their consent
研究组 & 干预措施
Kidney transplanted patients treated with Nulojix
Patients treated with Simulect as induction, and with Nulojix®, mycophenolic acid and steroids as maintenance therapy during the first year of kidney transplant.
干预措施: Belatacept Injection [Nulojix] (Drug)
结局指标
主要结局
Acute rejection occurence
时间窗: 1 year or rejection
Occurence of cellular rejection according to the BANFF 2017
次要结局
- Lymphocyte phenotype(1 year or rejection)
- Gut and circulating microbiota(1 year or rejection)
- Glomerular filtration rate(1 year or rejection)