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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976010
• Other study ID #: EA2/162/17
• Status: Completed
• Start date: July 17, 2021
• Est. completion date: November 19, 2021

Study information

• Verified date: February 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 19, 2021
• Est. primary completion date: November 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cardiovascular Diseases
• Chronic Kidney Diseases
• Communicable Diseases
• Infections
• Kidney Diseases
• Microbial Colonization
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunephenotyping of human PBMC	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.	at recruitment
Secondary	Microbiome sequencing of fecal samples	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.	at recruitment
Secondary	Targeted metabolomics of plasma samples	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).	at recruitment
Secondary	Pulse wave velocity	The pulse wave velocity (m/s) will be measured in all recruited patients by usinfg the Mobilograph. Data will be normalized to age.	at recruitment
Secondary	Carotid intima media thickness	The carotid intima media thickness (mm) will be measured using ultrasound imaging of the carotid vessel. Data will be normalized to age.	at recruitment
Secondary	Echocardiography	A basic echocardiography will be conducted evaluating diastolic and systolic, right and left ventricular function parameters.	at recruitment