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OpenTrials
Completed

NCT Number: NCT04976010

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

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.

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Key information

Conditions

Chronic Kidney Diseases Aging Cardiovascular Diseases Chronic Disease Communicable Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Immunephenotyping of human PBMC

    Time frame: 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.

Secondary outcomes

  1. Microbiome sequencing of fecal samples

    Time frame: at recruitment

    16S 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.

  2. Targeted metabolomics of plasma samples

    Time frame: at recruitment

    By 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).

  3. Pulse wave velocity

    Time frame: at recruitment

    The pulse wave velocity (m/s) will be measured in all recruited patients by usinfg the Mobilograph. Data will be normalized to age.

  4. Carotid intima media thickness

    Time frame: at recruitment

    The carotid intima media thickness (mm) will be measured using ultrasound imaging of the carotid vessel. Data will be normalized to age.

  5. Echocardiography

    Time frame: at recruitment

    A basic echocardiography will be conducted evaluating diastolic and systolic, right and left ventricular function parameters.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2021
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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