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NCT Number: NCT02022046

Methylation Biosignature in Childhood Chronic Kidney 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.

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Key information

Conditions

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

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic kidney disease stage 1-4
  • Volunteer

Exclusion criteria

  • pregnancy
  • renal transplant
  • congenital heart disease
  • not able to be adherent/complaint with study procedure
  • not volunteer

Treatment and study plan

Methylation biosignature

Other

Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    EQ-5D-Y instrument will be employed at the time of enrollment, 6 months, 12 months, 18 months, 24 months

  2. 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

    at the time of enrollment, 6 months, 12 months, 18 months, 24 months

  3. 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

    at the time of enrollment, 6 months, 12 months, 18 months, 24 months

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Methylation Biosignature in Childhood Chronic Kidney Disease: the Link Among Asymmetric Dimethylarginine, Homocysteine, and Cardiovascular Disease

Acronym: childhoodCKD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 27, 2013
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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