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

NCT ID: NCT04976010

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-17
• Study Completion Date: 2021-11-19

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CKD G3-5

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

No intervention

Intervention Type: OTHER

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

End stage kidney disease (ESKD) CKD G5 Hemodialysis

Patients on hemodialysis for at least 3 months

No intervention

Intervention Type: OTHER

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

Normal kidney function

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

No intervention

Intervention Type: OTHER

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

Interventions

No intervention

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Johannes Benjamin Holle

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominik Müller, MD

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Countries

Germany

Other Identifiers

EA2/162/17

Identifier Type: -

Identifier Source: org_study_id