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

NCT01452360 | Unknown

• 1 other identifier: 100009
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease

Study Arms (3)

Collection of CKD patient group

Collection of CKD high-risk group

Collection of healthy control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

chronic kidney disease patients

You may qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University - Shuang-Ho Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yung-Ho Hsu

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: May 1, 2011
• Study Completion: May 1, 2014
• Last Updated: October 14, 2011

Record last verified: 2011-10

Locations

TW (1)