Chronic Kidney DiseaseNCT01452360
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
An observational study of Chronic Kidney Disease, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2011to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: chronic kidney disease patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Collection of CKD patient group | Not described | |
| Collection of CKD high-risk group | Not described | |
| Collection of healthy control group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startMay 2011
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Ho Hsu, Taipei Medical University WanFang Hospital
- Investigators
- Yung-Ho Hsu, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452360
- Sponsor's protocol ID
- 100009
- Status last verified
- Oct 2011
- First submitted
- 11 Oct 2011
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01452360
- Acronym / sponsor ID
- 100009
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- May 2011
- Study completion
- May 2014 (estimated)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Collection of CKD patient group | – | – |
| Collection of CKD high-risk group | – | – |
| Collection of healthy control group | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- chronic kidney disease patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2011.
Related trials for Chronic Kidney Disease
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
RecruitingPhase 2
UBT251 Injection Phase II Clinical Study (CKD)
Obesity &Amp; Overweight, Chronic Kidney Disease
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
RecruitingPhase 2
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Atherosclerosis, Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yung-Ho Hsu principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2011.