Childhood Chronic Kidney DiseaseNCT03227055
Cardiovascular Comorbidity in Children With Chronic Kidney Disease
An observational study of Childhood Chronic Kidney Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This 3-year study will systematically evaluate the prevalence, clinical symptoms, and progression of CV and kidney disease and assess the impact of potential genetic, pharmacological, behavior, and environmental risk factors in a prospective cohort with a sample size of 125 aged 3-18 years children with stage G1-G4… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Chronic Kidney Disease
- How many people
- 155 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Dec 2016to 31 Dec 2019
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 125 children and adolescents with stage G1-G4 CKD and 30 controls.
Who may be able to join
- children and adolescents with stage G1-G4 CKD
Who cannot join
- current pregnancy
- inability to complete major data collection
- kidney transplant
- cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Comorbidity in Children With Chronic Kidney Disease: Identification of Novel Biomarkers and Therapeutic Targets
This 3-year study will systematically evaluate the prevalence, clinical symptoms, and progression of CV and kidney disease and assess the impact of potential genetic, pharmacological, behavior, and environmental risk factors in a prospective cohort with a sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD). Measurements of morphological (e.g., LVMI \& cIMT) and functional characteristics (e.g., FMD \& PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA \& urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.
Read the detailed description
Taiwan has the highest incidence and prevalence rates of end-stage renal disease all over the world. Chronic kidney disease (CKD) becomes a global public health burden, which can begin in earliest childhood. CKD in childhood differs from that in adults. Congenital anomalies of the kidney and urinary tract (CAKUT) is the leading cause of childhood CKD. Children with CKD due to CAKUT have the highest risk of having a genomic imbalance. Thus, early identification of genotype-phenotype correlations to develop novel therapeutic approaches might reduce the heavy burden of CKD for the future of Taiwan.
Study design:
- A 3-year prospective cohort study.
- Sample size: 125 children and adolescents with stage G1-G4 CKD, age 3 to 18 yr, and 30 controls.
- Measurement: Measurements of morphological (e.g., LVMI \& cIMT) and functional characteristics (e.g., FMD \& PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA \& urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.
- Conditions
- Childhood Chronic Kidney Disease
- Keywords
- Arterial stiffness, children, chronic kidney disease, hypertension, microRNA
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CKD | Children and adolescents with stage G1-G4 CKD, age 3 to 18 yr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension
Abnormal ABPM profile
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start30 Dec 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tain, You-Lin, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227055
- Sponsor's protocol ID
- 201601181A3
- Status last verified
- Feb 2024
- First submitted
- 19 Jul 2017
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Comorbidity in Children With Chronic Kidney Disease: Identification of Novel Biomarkers and Therapeutic Targets
- ClinicalTrials.gov ID
- NCT03227055
- Acronym / sponsor ID
- 201601181A3
- Conditions
- Childhood Chronic Kidney Disease
- Keywords
- Arterial stiffness, children, chronic kidney disease, hypertension, microRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Jul 2017 (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.
This 3-year study will systematically evaluate the prevalence, clinical symptoms, and progression of CV and kidney disease and assess the impact of potential genetic, pharmacological, behavior, and environmental risk factors in a prospective cohort with a sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD). Measurements of morphological (e.g., LVMI \& cIMT) and functional characteristics (e.g., FMD \& PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA \& urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.
Detailed description
Taiwan has the highest incidence and prevalence rates of end-stage renal disease all over the world. Chronic kidney disease (CKD) becomes a global public health burden, which can begin in earliest childhood. CKD in childhood differs from that in adults. Congenital anomalies of the kidney and urinary tract (CAKUT) is the leading cause of childhood CKD. Children with CKD due to CAKUT have the highest risk of having a genomic imbalance. Thus, early identification of genotype-phenotype correlations to develop novel therapeutic approaches might reduce the heavy burden of CKD for the future of Taiwan.
Study design:
- A 3-year prospective cohort study.
- Sample size: 125 children and adolescents with stage G1-G4 CKD, age 3 to 18 yr, and 30 controls.
- Measurement: Measurements of morphological (e.g., LVMI \& cIMT) and functional characteristics (e.g., FMD \& PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA \& urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD | – | –Children and adolescents with stage G1-G4 CKD, age 3 to 18 yr |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 125 children and adolescents with stage G1-G4 CKD and 30 controls.
Key inclusion criteria (1 listed)
- children and adolescents with stage G1-G4 CKD
Key exclusion criteria (4 listed)
- current pregnancy
- inability to complete major data collection
- kidney transplant
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypertension
Time frame: 1 year
Abnormal ABPM profile
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 20 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Childhood Chronic Kidney Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 20 Feb 2024. 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 Taiwan. 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?
Hypertension (time frame: 1 year). 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 20 Feb 2024.