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Clinical Trials/NCT03227055
NCT03227055
Completed
N/A

Cardiovascular Comorbidity in Children With Chronic Kidney Disease: Identification of Novel Biomarkers and Therapeutic Targets

Chang Gung Memorial Hospital1 site in 1 country155 target enrollmentDecember 30, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Childhood Chronic Kidney Disease
Sponsor
Chang Gung Memorial Hospital
Enrollment
155
Locations
1
Primary Endpoint
Hypertension
Status
Completed
Last Updated
2 years ago

Overview

Brief 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 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: 1. A 3-year prospective cohort study. 2. Sample size: 125 children and adolescents with stage G1-G4 CKD, age 3 to 18 yr, and 30 controls. 4. 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.

Registry
clinicaltrials.gov
Start Date
December 30, 2016
End Date
December 31, 2019
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tain, You-Lin

Professor

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • children and adolescents with stage G1-G4 CKD

Exclusion Criteria

  • current pregnancy
  • inability to complete major data collection
  • kidney transplant

Outcomes

Primary Outcomes

Hypertension

Time Frame: 1 year

Abnormal ABPM profile

Study Sites (1)

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