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

NCT04976010 | Completed

• 1 other identifier: EA2/162/17
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Cardiovascular Diseases; Microbial Colonization; Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Microbiome sequencing of fecal samples

  at recruitment

• Targeted metabolomics of plasma samples

  at recruitment

• Pulse wave velocity

  at recruitment

• Carotid intima media thickness

  at recruitment

• Echocardiography

  at recruitment

Study Arms (3)

CKD G3-5

Patients with CKD and an estimated eGFR \< 60ml/min not yet on dialysis

Other: No intervention

End stage kidney disease (ESKD) CKD G5 Hemodialysis

Patients on hemodialysis for at least 3 months

Other: No intervention

Normal kidney function

Patients enrolled with normal kidney function and/or CKD G1 and an estimated eGFR \> 90ml/min

Other: No intervention

Interventions

No intervention OTHER

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

CKD G3-5; End stage kidney disease (ESKD) CKD G5 Hemodialysis; Normal kidney function

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Only patients treated at the Department of Pediatric Nephrology in Berlin (Charité), Hamburg (UKE) and Leipzig (KfH) will be recruited for this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fecal and blood samples will be collected at a single timepoint at study enrollment.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases; Communicable Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Dominik Müller, MD

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: July 26, 2021
• Study Start: July 17, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)