Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Comorbidity in Children With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03227055
Recruitment Status : Unknown
Verified July 2017 by Tain, You-Lin, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Tain, You-Lin, Chang Gung Memorial Hospital

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.

Condition or disease
Childhood Chronic Kidney Disease

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Comorbidity in Children With Chronic Kidney Disease: Identification of Novel Biomarkers and Therapeutic Targets
Actual Study Start Date : December 30, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
CKD
Children and adolescents with stage G1-G4 CKD, age 3 to 18 yr



Primary Outcome Measures :
  1. Hypertension [ Time Frame: 1 year ]
    Abnormal ABPM profile


Biospecimen Retention:   Samples With DNA
Plasma, urine, and stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
125 children and adolescents with stage G1-G4 CKD and 30 controls.
Criteria

Inclusion Criteria:

  • children and adolescents with stage G1-G4 CKD

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227055


Contacts
Layout table for location contacts
Contact: You-Lin Tain, MD, PhD +886-7-7317123 ext 8723 tainyl@hotmail.com
Contact: Chien-Ning Hsu, PhD +886-7-7317123 ext 6131 chien_ning_hsu@hotmail.com

Locations
Layout table for location information
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: You-Lin Tain, MD, PhD       tainyl@hotmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Layout table for additonal information
Responsible Party: Tain, You-Lin, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03227055    
Other Study ID Numbers: 201601181A3
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tain, You-Lin, Chang Gung Memorial Hospital:
Arterial stiffness, children, chronic kidney disease, hypertension, microRNA
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency