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Association analysis of clinical parameter, biomarker and cardiovascular complication with dialysis cohort in end stage renal disease patients

Status Approved

First Submitted Date

2017/01/12
Registered Date

2018/10/19
Last Updated Date

2018/08/03

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003281
Unique Protocol ID	2016-04-039-001
Public/Brief Title	A study of cardiovascular complication in the patients on end stage renal disease with hemodialysis
Scientific Title	Association analysis of clinical parameter, biomarker and cardiovascular complication with dialysis cohort in end stage renal disease patients
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KHNMC-2016-04-039-001
Approval Date	2016-06-07
Institutional Review Board Name	Kyung Hee University Hospital at Gang dong IRB
Institutional Review Board Address	Kyung Hee University at Gangdong. Dong Nam Ro 892, Gang dong gu, Seoul, Korea
Institutional Review Board Telephone	02-440-7000
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Yang Gyun Kim
Title	MD, PhD
Telephone	+82-2-440-6091
Affiliation	Kyung Hee University Hospital at Gangdong
Address	DongNam Ro 892, Gang Dong gu, Seoul, Korea
Contact Person for Public Queries
Name	Hee Yun Jang
Title	research nurse
Telephone	+82-2-440-6882
Affiliation	Kyung Hee University Hospital at Gangdong
Address	DongNam Ro 892, Gang Dong gu, Seoul, Korea
Contact Person for Updating Information
Name	Hee Yun Jang
Title	research nurse
Telephone	+82-2-440-6882
Affiliation	Kyung Hee University Hospital at Gangdong
Address	DongNam Ro 892, Gang Dong gu, Seoul, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 6
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-06-27 Actual
Target Number of Participant	1000
Primary Completion Date
Study Completion Date
Name of Study	Bundang CHA General Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-06-27 ,
Recruitment Status by Participating Study Site 2
Name of Study	Kyung Hee University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-06-27 ,
Recruitment Status by Participating Study Site 3
Name of Study	VHS Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2016-06-27 ,
Recruitment Status by Participating Study Site 4
Name of Study	Seoul Redcross Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-06-27 ,
Recruitment Status by Participating Study Site 5
Name of Study	Kyung Hee University Hospital at Gangdong
Recruitment Status	Recruiting
Date of First Enrollment	2016-06-27 ,
Recruitment Status by Participating Study Site 6
Name of Study	Koera University Guro Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2017-11-20 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Kyung Hee University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University Hospital at Gangdong
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Cardiovascular disease is most common cause of mortality in the patients who are on hemodialysis (HD). The pathophysiology of major comorbidities, such as atherosclerotic complications in the patients with chronic kidney disease (CKD) differs substantially from that of the general populations. Between 30 and 50% of prevalent patients have elevated serum levels of inflammatory markers and the presence of inflammation has been found to be associated with increased mortality risk. Many biomarkers and risk stratifying method used in the general population like brain natriuretic peptide (BNP), troponin-I (Tn-I) and Framingham risk score were not useful in the patients with ESRD. Therefore, biomarkers to predict the risk of cardiovascular disease should be discovered to decrease cardiovascular morbidity and mortality. We plan to collect the clinical, laboratory data and cfDNA measurement in 500 patients receiving maintenance hemodialysis. This study purposed the comparison of cfDNA and currently operational laboratory findings as a useful biomarker in HD patients. So, sample size is bigger the better. However, the cost for control the plasma samples and measurement of cfDNA may be considerable. Therefore, we limited enrollment of the patients under 500 patients.

Study Summary Information

Lay Summary

Cardiovascular disease is most common cause of mortality in the patients who are on hemodialysis (HD). The pathophysiology of major comorbidities, such as atherosclerotic complications in the patients with chronic kidney disease (CKD) differs substantially from that of the general populations. Between 30 and 50&#37; of prevalent patients have elevated serum levels of inflammatory markers and the presence of inflammation has been found to be associated with increased mortality risk. Many biomarkers and risk stratifying method used in the general population like brain natriuretic peptide (BNP), troponin-I (Tn-I) and Framingham risk score were not useful in the patients with ESRD. Therefore, biomarkers to predict the risk of cardiovascular disease should be discovered to decrease cardiovascular morbidity and mortality. We plan to collect the clinical, laboratory data and cfDNA measurement in 500 patients receiving maintenance hemodialysis. This study purposed the comparison of cfDNA and currently operational laboratory findings as a useful biomarker in HD patients. So, sample size is bigger the better. However, the cost for control the plasma samples and measurement of cfDNA may be considerable. Therefore, we limited enrollment of the patients under 500 patients.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Prospective
Target Number of Participant	1000
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label The patients on hemodialysis in 5 centers
Cohort/ Group 1	Cohort/Group Description We includes adult (>18 years old) dialysis patients. They treat hemodialysis three times a week and their Kt/v must be upper 1.2. We obtained the informed contents from enrolled patients.We will collect questionnaire relating quality of life, depression and cognitive function and assess physical capacity. Also clinical and laboratory information will be obtained. Finally, we are purposed to find diagnostic biomarker to predict cardiovascular event in the patients with hemodialysis through serum sample.
Biospecimen Collection & Archiving	: DNA Collect & Archive: Sample with DNA
Biospecimen Description	whole blood, plasma

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	The patients on hemodialysis
Sampling Method	We only included the patients gave us informed consent (nonprobability method)
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N18.5)Chronic kidney disease, stage 5
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description Age: more than 18 years old the patients on maintaining hemodialysis three times a week spKt/v more than 1.2 the patients wrote informed consents
Exclusion Criteria	the patients with hematologic malignancies the patients not treated from solid organ malignancy the patients with expectancy less than 6 months
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	All-cause mortality, cardiovascular mortality, cardiovascular disease
Timepoint	after 5 years
Secondary Outcome(s) 1
Outcome	chronic kidney disease-metabolic bone disease, control of anemia
Timepoint	after 5 years

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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