Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03227055 |
| Other study ID # |
201601181A3 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2016 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
February 2024 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
