Clinical trial NCT03227055: Cardiovascular Comorbidity in Children With Chronic Kidney Disease
Official title: Cardiovascular Comorbidity in Children With Chronic Kidney Disease: Identification of Novel Biomarkers and Therapeutic Targets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Chronic Kidney Disease
Keywords: Arterial stiffness, children, chronic kidney disease, hypertension, microRNA
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 155
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 125 children and adolescents with stage G1-G4 CKD and 30 controls.

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.

Eligibility criteria: Inclusion Criteria:

* children and adolescents with stage G1-G4 CKD

Exclusion Criteria:

* current pregnancy
* inability to complete major data collection
* kidney transplant
* cancer

Primary outcomes:
measure: Hypertension
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References: