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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

NCT ID: NCT01452360

Last Updated: 2011-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Study Groups

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Collection of CKD patient group

No interventions assigned to this group

Collection of CKD high-risk group

No interventions assigned to this group

Collection of healthy control group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.
3. 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yung-Ho Hsu

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yung-Ho Hsu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical University - Shuang-Ho Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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100009

Identifier Type: -

Identifier Source: org_study_id