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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Yung-Ho Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01452360
First received: October 11, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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.


Condition
Chronic Kidney Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Estimated Enrollment: 700
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Groups/Cohorts
Collection of CKD patient group
Collection of CKD high-risk group
Collection of healthy control group

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

chronic kidney disease patients

Criteria

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.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01452360

Locations
Taiwan
Taipei Medical University - Shuang-Ho Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Yung-Ho Hsu Taipei Medical University Shuang Ho Hospital
  More Information

No publications provided

Responsible Party: Yung-Ho Hsu, doctor, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01452360     History of Changes
Other Study ID Numbers: 100009
Study First Received: October 11, 2011
Last Updated: October 11, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 20, 2014