Chronic Kidney DiseasesNCT04976010
Single Cell Leukocyte Landscapes and Cardiovascular Risk in Children With Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Cardiovascular Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Chronic Kidney Diseases, Cardiovascular Diseases, Microbial Colonization
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jul 2021to 19 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin
Berlin, 13353
About this study
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.
- Being tested
- No intervention
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There will be no intervention in the separate goups, as this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| CKD G3-5 | Patients with CKD and an estimated eGFR < 60ml/min not yet on dialysis Receives: Other: No intervention | |
| End stage kidney disease (ESKD) CKD G5 Hemodialysis | Patients on hemodialysis for at least 3 months Receives: Other: No intervention | |
| Normal kidney function | Patients enrolled with normal kidney function and/or CKD G1 and an estimated eGFR > 90ml/min Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at recruitment
Secondary outcomes (5)
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.
Measured: at recruitment
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).
Measured: at recruitment
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.
Measured: at recruitment
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.
Measured: at recruitment
Echocardiography
A basic echocardiography will be conducted evaluating diastolic and systolic, right and left ventricular function parameters.
Measured: at recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start17 Jul 2021
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Benjamin Holle, Charite University, Berlin, Germany
- Investigators
- Dominik Müller, MD, Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976010
- Sponsor's protocol ID
- EA2/162/17
- Status last verified
- Feb 2022
- First submitted
- 3 Jul 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Cell Leukocyte Landscapes and Cardiovascular Risk in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04976010
- Acronym / sponsor ID
- EA2/162/17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 17 Jul 2021 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD G3-5 | – | Other: No interventionPatients with CKD and an estimated eGFR < 60ml/min not yet on dialysis |
| End stage kidney disease (ESKD) CKD G5 Hemodialysis | – | Other: No interventionPatients on hemodialysis for at least 3 months |
| Normal kidney function | – | Other: No interventionPatients enrolled with normal kidney function and/or CKD G1 and an estimated eGFR > 90ml/min |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- body weight of less than 15kg
- acute or chronic inflammatory diseases
- fever
- diabetes
- chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere will be no intervention in the separate goups, as this is an observational study | Other | CKD G3-5, End stage kidney disease (ESKD) CKD G5 Hemodialysis, Normal kidney function |
Primary outcome
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.
5 secondary outcomes
Microbiome sequencing of fecal samples
Time frame: at recruitment
Targeted metabolomics of plasma samples
Time frame: at recruitment
Pulse wave velocity
Time frame: at recruitment
Carotid intima media thickness
Time frame: at recruitment
Echocardiography
Time frame: at recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik Müller, MD study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Cardiovascular Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunephenotyping of human PBMC (time frame: at recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.