Chronic Kidney DiseasechildhoodCKDNCT02022046
Methylation Biosignature in Childhood Chronic Kidney Disease
An observational study of Chronic Kidney Disease and Cardiovascular Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Cardiovascular Disease
- What is being tested?
- Methylation biosignature
- How many people
- 69 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to Dec 2016
- 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: Children aged <18 years visit pediatric nephrology clinic during study period
Who may be able to join
- chronic kidney disease stage 1-4
- Volunteer
Who cannot join
- pregnancy
- renal transplant
- congenital heart disease
- not able to be adherent/complaint with study procedure
- not volunteer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease
Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as a methylation biomarker.
In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor. S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase (MTHFR), a folate metabolism enzyme can regulate methylation pathway.
The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene methylation can serve as biosignature to predict CVD in children with CKD children.
- Conditions
- Chronic Kidney Disease, Cardiovascular Disease
- Being tested
- Methylation biosignature
- Keywords
- chronic kidney disease, cardiovascular disease, nitric oxide, homocysteine, asymmetric dimethylarginine, methylation
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylation biosignatureOther
Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 2/study, control | Study group: children aged<18 years with chronic kidney disease Control group: children aged<18 years without chronic kidney disease Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed. Receives: Other: Methylation biosignature |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months
at the time of enrollment, 6 months, 12 months, 18 months, and 24 months
Measured: from the time of enrollment, every 6 months, up to 24 months
Secondary outcomes (3)
change from the baseline health-related quality of life at 24 months
EQ-5D-Y instrument will be employed at the time of enrollment, 6 months, 12 months, 18 months, 24 months
Measured: from the time of enrollment, every 6 months, up to 24 months
change from the baseline ratio of SAM/SAH (S-adenosylmethionine /S-adenosylhomocysteine ) at 24 months
at the time of enrollment, 6 months, 12 months, 18 months, 24 months
Measured: from the time of enrollment, every 6 months, up to 24 months
change from the baseline level of hyperhomocysteinemia (Hcy) at 24 months
at the time of enrollment, 6 months, 12 months, 18 months, 24 months
Measured: from the time of enrollment, every 6 months, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 69 participants (actual)
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
- Investigators
- You-Lin Tain, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022046
- Sponsor's protocol ID
- 102-4131C
- Acronym
- childhoodCKD
- Status last verified
- Jul 2017
- First submitted
- 11 Dec 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02022046
- Acronym / sponsor ID
- childhoodCKD / 102-4131C
- Conditions
- Chronic Kidney Disease, Cardiovascular Disease
- Keywords
- chronic kidney disease, cardiovascular disease, nitric oxide, homocysteine, asymmetric dimethylarginine, methylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- 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) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as a methylation biomarker.
In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor. S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase (MTHFR), a folate metabolism enzyme can regulate methylation pathway.
The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene methylation can serve as biosignature to predict CVD in children with CKD children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2/study, control | – | Other: Methylation biosignatureStudy group: children aged<18 years with chronic kidney disease Control group: children aged<18 years without chronic kidney disease Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children aged <18 years visit pediatric nephrology clinic during study period
Key inclusion criteria (2 listed)
- chronic kidney disease stage 1-4
- Volunteer
Key exclusion criteria (5 listed)
- pregnancy
- renal transplant
- congenital heart disease
- not able to be adherent/complaint with study procedure
- not volunteer
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 |
|---|---|---|
| Methylation biosignatureMethylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed. | Other | 2/study, control |
Primary outcome
change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months
Time frame: from the time of enrollment, every 6 months, up to 24 months
at the time of enrollment, 6 months, 12 months, 18 months, and 24 months
3 secondary outcomes
change from the baseline health-related quality of life at 24 months
Time frame: from the time of enrollment, every 6 months, up to 24 months
change from the baseline ratio of SAM/SAH (S-adenosylmethionine /S-adenosylhomocysteine ) at 24 months
Time frame: from the time of enrollment, every 6 months, up to 24 months
change from the baseline level of hyperhomocysteinemia (Hcy) at 24 months
Time frame: from the time of enrollment, every 6 months, up to 24 months
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 21 Jul 2017.
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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.
You-Lin Tain, MD, PhD principal investigator
Chang Gung Memorial Hospital
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 Disease and Cardiovascular 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 2 inclusion and 5 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 21 Jul 2017. 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?
change from baseline level of asymmetric dimethylarginine (ADMA) at 24 months (time frame: from the time of enrollment, every 6 months, up to 24 months). 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 21 Jul 2017.