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临床试验/NCT04976010
NCT04976010已完成不适用

Single Cell Leukocyte Landscapes and Cardiovascular Risk in Children With Chronic Kidney Disease

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Immunephenotyping of human PBMC

研究概览

简要总结

Chronic kidney disease (CKD) is associated with an increased cardiovascular mortality. In particular children with early-onset CKD have a lifelong increased risk to suffer from cardiovascular disease (CVD). Therefore, children with CKD deserve our attention. The immune system in children with CKD is disturbed, exhibiting pro-inflammatory features. Therefore, we aim to learn more about the characteristics of the immune system in early-onset CKD. In this project PBMC of pediatric CKD patients and age-matched healthy controls will be analysed and compared using CITE-Seq as a multimodal scRNAseq phenotyping method. All patients will be clinically characterized to integrate cardiovascular and immunological data.

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
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • matching to one of the following groups CKD G3-5: estimated eGFR according to Schwartz formula <60ml/min*1,73m2 (no ESKD) CKD G5 D: patients with ESKD treated with hemodialysis for at least 3 months normal kidney function: CKD G1 or no CKD with eGFR > 90ml/min*1,73m2
  • informed consent to participate in this study

排除标准

  • body weight of less than 15kg
  • acute or chronic inflammatory diseases
  • chronic liver disease
  • inflammatory bowel disease or other gastrointestinal disorders (constipation, diarrhea, short bowel syndrome)
  • antibiotic prophylaxis or treatment within four weeks prior to recruitment

结局指标

主要结局

Immunephenotyping of human PBMC

时间窗: at recruitment

scRNAseq with Cellular Indexing of Transcriptomes and Epitopes (CITE)-Seq for whole PBMC will be used to gain information on single cell transcriptomes across multiple immune cell populations together with expression levels of classical mmunological surface markers.

次要结局

  • Pulse wave velocity(at recruitment)
  • Echocardiography(at recruitment)
  • Targeted metabolomics of plasma samples(at recruitment)
  • Carotid intima media thickness(at recruitment)
  • Microbiome sequencing of fecal samples(at recruitment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Johannes Benjamin Holle

Dr. med.

Charite University, Berlin, Germany

研究点 (1)

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