Status Approved
First Submitted Date
2021/01/07
Registered Date
2021/02/04
Last Updated Date
2021/09/29
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005865 |
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Unique Protocol ID | CNUH-2020-391 |
Public/Brief Title | Chonnam National University observational Cohort Study for Improved Outcomes in patients with Chronic Kidney Disease |
Scientific Title | Chonnam National University observational Cohort Study for Improved Outcomes in patients with Chronic Kidney Disease |
Acronym | CONSERVE-CKD |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | CNUH-2020-391 |
Approval Date | 2021-01-06 |
Institutional Review Board Name | Chonnam National University Hospital Institutional review board |
Institutional Review Board Address | 42, Jebongro, Donggu, Gwangju, Korea |
Institutional Review Board Telephone | 062-220-5257 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Soo Wan Kim |
Title | PI |
Telephone | +82-62-220-6271 |
Affiliation | Chonnam National University Hospital |
Address | 42, Jebongro, Donggu, Gwangju, Korea |
Contact Person for Public Queries | |
Name | TaeRyom Oh |
Title | Assistant professor |
Telephone | +82-62-220-6292 |
Affiliation | Chonnam National University Hospital |
Address | 42, Jebongro, Donggu, Gwangju, Korea |
Contact Person for Updating Information | |
Name | TaeRyom Oh |
Title | Co-PI |
Telephone | +82-62-220-6292 |
Affiliation | Chonnam National University Hospital |
Address | 42, Jebongro, Donggu, Gwangju, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-10-01 Anticipated | |
Target Number of Participant | 4000 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Chonnam National University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-10-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chonnam National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | [Research Purpose] 1) Collecting data on the clinical course of chronic kidney disease and disease progression 2) Collecting data on the occurrence of end-stage renal failure, including the reduction of mortality, glomerular filtration rate and initiation of renal replacement therapy, and its impact on quality of life and mental health. 3) Identify the factors that involved in the progression of chronic kidney disease 4) Collecting data of complications of chronic kidney disease 5) Identify risk factors of complications development and predict high risk groups 6) Establishment of treatment guidelines including modification of lifestyle of patients with chronic kidney disease and medication [Research method] Considering the domestic situation in which the prevalence of chronic kidney disease increases due to the high aging index and the increase in the prevalence of diabetes and hypertension in the Gwangju/Jeonnam region, identification of clinical courses including changes in renal function, mortality and complications of chronic kidney disease is very important. In addition, it is of great significance to investigate the risk factors, biochemical indicators, and genetic factors which are related with chronic kidney disease. To achieve these goals, we will establish a cohort representing chronic kidney disease in Gwangju/Jeonnam region, and common guidelines for follow-up of cohort subjects. 1) Study Design: Adult (19-79 years old) chronic kidney disease patient registration and chronic kidney disease cohort study 2) Establishment of active follow-up system for patients undergoing nephrology treatment at Chonnam National University Hospital and investigation of factors related to complications and prognosis of chronic kidney disease 3) Stable sample banking for the subject and establishment of storage systems for banking 4) Establishment of research infrastructure -Development of questionnaire, consent form, case record sheet, and follow-up observation sheet -Establishment of patient database [Expected results] 1) Obtaining basic data on the clinical course, mortality rate, incidence of various complications, and risk factors of complications of chronic kidney disease in Koreans 2) Statistical evidence on the effects of chronic kidney disease on public health, social and economic losses are presented. 3) Identify risk factors for rapid progression of chronic kidney disease, and enable early detection of high-risk group and early intervention. 4) Identify risk factors for various complications of chronic kidney disease, and enable early detection of high-risk group and early intervention. 5) Provides data for diabetic kidney disease, the most common cause of chronic kidney disease and for early detection and management of various complications including cardiovascular complication which is most common cause of death. 6) Suggestion of treatment guidelines including modification of lifestyle for patients with chronic kidney disease 7) This database can be used as representative data for chronic kidney disease in Koreans, and can be used to establish international guidelines for chronic kidney disease. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 4000 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Chronic Kidney Disease |
Cohort/Group Description [Baseline data on registration] 1) Demographic data: date of birth, gender, contact information, smoking and drinking history 2) Questionnaire: -Health questionnaire: Use a modified questionnaire form to apply chronic kidney disease. -KDQOL-SF36: Quality of life assessment -PHQ-9: Depression screening test 3) medical history data -Causes of chronic kidney disease -History: cardiovascular disease, stroke, gestational diabetes, and high blood pressure (for women), -Family history: Diabetes. High blood pressure, cardiovascular disease, stroke -Medication history (within the last 1 month): Antihypertensive drugs, hypoglycemic drugs, hyperlipidemia drugs, NSAIDs, antibiotics, radiation contrast agents, phosphorus binding agents, vitamins, uric acid-lowering drugs such as allopurinol, iron, hematopoietic hormones 4) blood pressure, heart rate 5) Nutrition evaluation -7-point SGA (Subjective Global Assessment): nutritional assessment -Skinfold: abdominal, triceps -MAMC (mid arm muscle circumference): triceps -Hand grip test -Weight, height, BMI, waist circumference, hip circumference [Follow-up items] 1) Recent events: dialysis/transplantation, cardiovascular complications, death, etc. 2) Medication history (within the last 1 month): Antihypertensive drugs, hypoglycemic drugs, hyperlipidemia drugs, NSAIDs, antibiotics, radiation contrast agents, phosphorus binding agents, vitamins, uric acid-lowering drugs such as allopurinol, iron, hematopoietic hormones 3) blood pressure, heart rate 4) Nutritional evaluation: every 3 years -Skin fold: abdominal, triceps -MAMC (mid arm muscle circumference): triceps -Hand grip test -7-point SGA -Weight, height, BMI, waist circumference, hip circumference 5) Health survey, QOL and PHQ-9: every 3 years or when outcome occurs |
|
Biospecimen Collection & Archiving |
: DNA Collect & Archive: Sample with DNA |
Biospecimen Description | plasma, buffy coat. urine |
9. Subject Eligibility
Study Population Description | Adult chronic kidney disease patients aged 19-79 |
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Sampling Method | Convenience sampling |
Condition(s)/Problem(s) |
* (N00-N99)Diseases of the genitourinary system (N18.5)Chronic kidney disease, stage 5 Renal Insufficiency, Chronic |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~79Year |
|
Description 1) Age 19-79 2) Patients who qualify the criteria for diagnosis of chronic kidney disease based on KDIGO guidelines |
|
Exclusion Criteria |
1) Those who have undergone dialysis for more than 3 months in the past 2) Those who received any organ transplantation 3) Patients with a history of receiving cancer treatment or currently undergoing cancer treatment (can be enrolled in cases where 5 years have elapsed without evidence of cancer recurrence and a cure is determined) 4) Pregnant women (however, registration is possible after 6 months of delivery) 5) Persons with one kidney due to accident or provision of a transplanted kidney (in case of congenital single kidney or unilateral atrophic kidney, registration is possible) 6) Those who refuse to provide consent for research, or who are unable to understand the research and voluntarily give consent 7) Those who are difficult to participate in the research due to the judgment of other researchers |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Dialysis, Kidney transplantations, eGFR declines ≥50% from baseline, Doubling of srum creatinine |
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Timepoint | evaluate on every visit |
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Primary Outcome(s) 2 | ||
Outcome | MI, PCI or CABS, Stroke, Hospitalization for congestive heart failure |
|
Timepoint | evaluate on every visit |
|
Primary Outcome(s) 3 | ||
Outcome | Death |
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Timepoint | evaluate on every visit |
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Secondary Outcome(s) 1 | ||
Outcome | ABI-PWV, albuminuria, SGA score |
|
Timepoint | ABI-PWV and SGA score will be evaluated on every 3 years, albuminuria will be evaluated on every visit |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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