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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04976010
Enrollment
38
Registered
2021-07-26
Start date
2021-07-17
Completion date
2021-11-19
Last updated
2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Cardiovascular Diseases, Chronic Kidney Diseases, Microbial Colonization

Brief summary

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.

Interventions

OTHERNo intervention

There will be no intervention in the separate goups, as this is an observational study

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* body weight of less than 15kg * acute or chronic inflammatory diseases * fever * diabetes * 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

Design outcomes

Primary

MeasureTime frameDescription
Immunephenotyping of human PBMCat recruitmentscRNAseq 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.

Secondary

MeasureTime frameDescription
Microbiome sequencing of fecal samplesat recruitment16S RNA amplicon sequencing and whole genome shotgun sequencing will be perfomred in fecal samples, collected in RNA/DNA shield. This will allow us insights in composition (abundances) and function of the gut microbiome.
Targeted metabolomics of plasma samplesat recruitmentBy using liquid-chromatography (LC) and gas-chromatography (GC) mass-spectrometry plasma samples will be analyzed for tryptophan metabolites and short chain fatty acids (absolute quantifiaction in µM).
Pulse wave velocityat recruitmentThe pulse wave velocity (m/s) will be measured in all recruited patients by usinfg the Mobilograph. Data will be normalized to age.
Carotid intima media thicknessat recruitmentThe carotid intima media thickness (mm) will be measured using ultrasound imaging of the carotid vessel. Data will be normalized to age.
Echocardiographyat recruitmentA basic echocardiography will be conducted evaluating diastolic and systolic, right and left ventricular function parameters.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026