Status:
UNKNOWN
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
Lead Sponsor:
Taipei Medical University WanFang Hospital
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
20+ years
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 eviden...
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】. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT01452360
Start Date
May 1 2011
End Date
May 1 2014
Last Update
October 14 2011
Active Locations (1)
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1
Taipei Medical University - Shuang-Ho Hospital
Taipei, Taiwan