A Research Proposal to Set up an Integrated National Data Bank and Monitoring System and to Establish the Indicators and Risk Factors for Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Locations
Taiwan
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Chronic Kidney Disease focused on measuring chronic kidney disease
Eligibility Criteria
Inclusion Criteria:
- Collection of CKD patient group: The patients who will select into this plan are chosen from the hospital (This hospital is defined as the renal disease improving institute) in Taiwan. New case in this hospital will be collected into the CKD patient group. In order to separate those patients into five stages of CKD, we are going to calculate the glomerular filtration rate (GFR) by using the formula of GFR. Stage I -- Renal function is normally and protein was detectable slightly in urine (GFR:≧90ml/min/1.73M2). Stage II -- Slight renal function failure was observed (GFR:60~89ml/min/1.73M2). Stage III -- Moderate renal function failure (GFR:30~59ml/min/1.73M2). Stage IV -- Severe renal function failure (GFR:15~29ml/min/1.73M2). Stage V -- End stage renal disease (GFR:<15ml/min/1.73M2). The age is from fourteen to eighty-five and whatever they are male or female will be taken into this project.
- Collection of CKD high-risk group: The CKD patient's relative will be considerately incorporated into the CKD high-risk group. If CKD patient being confirmed, their relative who had chronic disease including DM, hypertension and CVD will be chosen into CKD high-risk group. The age is from fourteen to eighty-five and whatever they are male or female. This plan will select five thousand people into CKD high-risk group.
- Collection of healthy control group: According to the characteristic of CKD patient group, we will select the health control group carefully (paired selection of CKD patient group, 1:1). The rules of paired selection : 1. Sex 2.Age ± 5 years 3.Location -- CKD patient and health people are get from the same hospital. Health people who had no any chronic disease and required a physical checkup which get from the hospital (This hospital should be qualified to the renal disease improving institute) will be chosen into this project. Fifteen hundred people will be taken in this plan.
Exclusion Criteria:
- This plan divide into three groups:1. CKD patient group -- CKD patient group have no exclusion criteria. 2. CKD high-risk group -- CKD high-risk group exclude the patient who had renal disease. 3. Heath control group -- Heath control group exclude the patient who had any chronic disease. Test of liver residual function will exclude the patient who had allergic reactions to galactose. It will exclude the person including galactosemia patient, DM patient, pregnant woman, children and disabled people.
Sites / Locations
- Taipei Medical University - Shuang-Ho Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Arm Label
Collection of CKD patient group
Collection of CKD high-risk group
Collection of healthy control group
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01452360
First Posted
October 11, 2011
Last Updated
October 11, 2011
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01452360
Brief Title
A Research Proposal to Set up an Integrated National Data Bank and Monitoring System and to Establish the Indicators and Risk Factors for Chronic Kidney Disease
Official Title
A Research Proposal to Set up an Integrated National Data Bank and Monitoring System and to Establish the Indicators and Risk Factors for Chronic Kidney Disease
Study Type
Observational
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project expects the integrated database of terminally renal ill patients combines clinical and files of Health Insurance and renal medical society database. It will provide valuable actual evidence data to quality monitoring of dialysis treatment and related academic research. Besides, using the cohort study of chronic renal disease --「epidemiologic research of chronic renal disease」, we can trace the patient continually and analysis different risk factors of chronic renal disease in Taiwan. Taken together, the results of this project --1.1「Integrate the current database of renal disease and establishment of national monitor system」and 1.2「Epidemiologic study in chronic renal disease」-- will provide the basic rules of prevention and treatment, basic research and clinic application in chronic renal disease.
Detailed Description
The main source of patient in this study sub-plan 1.2 will collect the patient from medical center in Taiwan. We assume collect 7 groups in study period -- First:【CKD stage I】. Second:【CKD stage II】. Third:【CKD stage III】. Forth:【CKD stage IV】. Fifth:【CKD stage V】. Sixth:【CKD high-risk group】. Seventh:【health control group】to study case report;Total collect 11500 people. At the same time, we collect the sample of blood and urine and personal health survey to provide the basic data base for each patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease
7. Study Design
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collection of CKD patient group
Arm Title
Collection of CKD high-risk group
Arm Title
Collection of healthy control group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Collection of CKD patient group: The patients who will select into this plan are chosen from the hospital (This hospital is defined as the renal disease improving institute) in Taiwan. New case in this hospital will be collected into the CKD patient group. In order to separate those patients into five stages of CKD, we are going to calculate the glomerular filtration rate (GFR) by using the formula of GFR. Stage I -- Renal function is normally and protein was detectable slightly in urine (GFR:≧90ml/min/1.73M2). Stage II -- Slight renal function failure was observed (GFR:60~89ml/min/1.73M2). Stage III -- Moderate renal function failure (GFR:30~59ml/min/1.73M2). Stage IV -- Severe renal function failure (GFR:15~29ml/min/1.73M2). Stage V -- End stage renal disease (GFR:<15ml/min/1.73M2). The age is from fourteen to eighty-five and whatever they are male or female will be taken into this project.
Collection of CKD high-risk group: The CKD patient's relative will be considerately incorporated into the CKD high-risk group. If CKD patient being confirmed, their relative who had chronic disease including DM, hypertension and CVD will be chosen into CKD high-risk group. The age is from fourteen to eighty-five and whatever they are male or female. This plan will select five thousand people into CKD high-risk group.
Collection of healthy control group: According to the characteristic of CKD patient group, we will select the health control group carefully (paired selection of CKD patient group, 1:1). The rules of paired selection : 1. Sex 2.Age ± 5 years 3.Location -- CKD patient and health people are get from the same hospital. Health people who had no any chronic disease and required a physical checkup which get from the hospital (This hospital should be qualified to the renal disease improving institute) will be chosen into this project. Fifteen hundred people will be taken in this plan.
Exclusion Criteria:
This plan divide into three groups:1. CKD patient group -- CKD patient group have no exclusion criteria. 2. CKD high-risk group -- CKD high-risk group exclude the patient who had renal disease. 3. Heath control group -- Heath control group exclude the patient who had any chronic disease. Test of liver residual function will exclude the patient who had allergic reactions to galactose. It will exclude the person including galactosemia patient, DM patient, pregnant woman, children and disabled people.
Study Population Description
chronic kidney disease patients
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Ho Hsu
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University - Shuang-Ho Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
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A Research Proposal to Set up an Integrated National Data Bank and Monitoring System and to Establish the Indicators and Risk Factors for Chronic Kidney Disease
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