Chronic Kidney DiseasesSCREENINGNCT03084172
Systemic Redesign and Demonstration for Early Detection, Evaluation and Management of Chronic Kidney Disease in Shanghai
An observational study of Chronic Kidney Diseases, run by Shanghai Changzheng Hospital at 34 sites in China.
Trial summary
Based on clinical evidence based medicine and organizational management model, investigators redesign the prevention and treatment of chronic kidney disease of public health system in Shanghai China. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 2,000,000 participants
- Where
- 34 sitesChina
- Study dates
- 1 Oct 2015to 1 Jun 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The residents in Jing'an District and Minhang District, which medical services are provided by those collaborative Community Health Service Center.
Who may be able to join
- Over 18 years of age.
- Signed informed consent
Who cannot join
- Refused to accept the blood and urine test
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
- Recruiting
Jiangning Road Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200040
- Recruiting
Jing'an District Central Hospital of Shanghai
Shanghai, Shanghai Municipality, 200040
- Recruiting
Jing'an Temple Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200040
- Recruiting
Second Shimen Road Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200041
- Recruiting
West Nanjing road Community Health Services Center of Shanghai
Shanghai, Shanghai Municipality, 200041
- Recruiting
Caojiadu Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200042
- Recruiting
Jing'an District Zhabei Central Hospital of Shanghai
Shanghai, Shanghai Municipality, 200070
- Recruiting
Tianmuxi Road Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200070
- Recruiting
Zhijiangxi Road Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200070
- Recruiting
Baoshan Community Health Services Center of Shanghai
Shanghai, Shanghai Municipality, 200071
- Recruiting
Beizhan Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200071
- Recruiting
Da'ning Community Health Services Center of Shanghai
Shanghai, Shanghai Municipality, 200072
- Recruiting
Gonghexin Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200072
- Recruiting
Pengpu zhen Community Health Services Center of Shanghai
Shanghai, Shanghai Municipality, 200072
- Recruiting
Jiangchuan Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200240
- Recruiting
The Fifth People's Hospital of Shanghai, Fudan University
Shanghai, Shanghai Municipality, 200240
- Recruiting
Wujing Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 200241
- Recruiting
Linfen Community Health Services Center of Shanghai
Shanghai, Shanghai Municipality, 200435
- Recruiting
Pengpu Community Health Services Center of Shanghai
Shanghai, Shanghai Municipality, 200435
- Recruiting
Jing'an District Shibei Hospital of Shanghai
Shanghai, Shanghai Municipality, 200443
- Recruiting
Minhang District Central Hospital of Shanghai
Shanghai, Shanghai Municipality, 201100
- Recruiting
Xinhong Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201100
- Recruiting
Xinzhuang Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201100
- Recruiting
Qibao Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201101
- Recruiting
Gumei Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201102
- Recruiting
Hongqiao Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201103
- Recruiting
Meilong Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201104
- Recruiting
Longbai Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201105
- Recruiting
Huacao Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201107
- Recruiting
Zhuanqiao Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201108
- Recruiting
Maqiao Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201111
- Recruiting
Pujiang Community Health Service Center of Shanghai
Shanghai, Shanghai Municipality, 201112
About this study
Based on clinical evidence based medicine and organizational management model, investigators redesign the prevention and treatment of chronic kidney disease of public health system in Shanghai China. The investigators hope to find early chronic kidney disease, prevention and clinical intervention of orderly combination. The advantages of this system were confirmed by comparing the prevalence rate, awareness rate and treatment rate before and after the completion of the system.
Read the detailed description
The whole study mainly includes the following parts:
- Establishment of a database of patients with kidney disease, and training data entry specialist in every center.
- Conduct propaganda of kidney disease knowledge, training professional doctors in center hospital and community hospital.
- Search for high-risk patients, and screening for patients with kidney disease from community residents in community hospital.
- Establishment of a standardized and orderly patient referral process from community hospital to center hospital or three level of first-class hospital.
- Conditions
- Chronic Kidney Diseases
- 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 |
|---|---|---|
| chronic kidney disease patients group | These patients were screened from 2000000 of the population. The investigator will compare the prevalence rate, awareness rate and treatment rate before and after the completion of the system. The degree of decreased glomerular filtration rate is also an important evaluation index. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence rate of chronic kidney disease
Change in prevalence rate of chronic kidney disease in shanghai from baseline to 3 years.
Measured: baseline and 12 months, an average of 3 years
awareness rate of chronic kidney disease
Change in awareness rate of chronic kidney disease in shanghai from baseline to 3 years.
Measured: baseline and 12 months, an average of 3 years
treatment rate of chronic kidney disease
Change in using standardized and orderly patient referral process from community hospital to center hospital or three level of first-class hospital. in shanghai from baseline to 3 years.
Measured: baseline and 12 months, an average of 3 years
The degree of decreased glomerular filtration rate in chronic kidney patients
The degree of decreased glomerular filtration rate in chronic kidney patients, compared with healthy people and reported level in the literatures
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Oct 2015
- Primary completion31 Dec 2017 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Commission of Health and Family Planning, Shanghai Municipal Center for Disease Control and Prevention, Huashan Hospital, Shanghai Minhang District Municipal Center for Disease Control and Prevention, Shanghai Jing'an District Municipal Center for Disease Control and Prevention, Fudan University, Minhang District Central Hospital of Shanghai, Jing'an District Central Hospital of Shanghai, Jing'an District Zhabei Central Hospital of Shanghai, Jing'an District Shibei Hospital of Shanghai, Linfen Community Health Services Center of Shanghai, Pengpu Community Health Services Center of Shanghai, Pengpu zhen Community Health Services Center of Shanghai, Da'ning Community Health Services Center of Shanghai, Gonghexin Community Health Service Center of Shanghai, Zhijiangxi Road Community Health Service Center of Shanghai, Tianmuxi Road Community Health Service Center of Shanghai, Beizhan Community Health Service Center of Shanghai, Baoshan Community Health Services Center of Shanghai, West Nanjing road Community Health Services Center of Shanghai, Second Shimen Road Community Health Service Center of Shanghai, Jiangning Road Community Health Service Center of Shanghai, Caojiadu Community Health Service Center of Shanghai, Jing'an Temple Community Health Service Center of Shanghai, Xinzhuang Community Health Service Center of Shanghai, Longbai Community Health Service Center of Shanghai, Gumei Community Health Service Center of Shanghai, Xinhong Community Health Service Center of Shanghai, Huacao Community Health Service Center of Shanghai, Hongqiao Community Health Service Center of Shanghai, Qibao Community Health Service Center of Shanghai, Meilong Community Health Service Center of Shanghai, Jiangchuan Community Health Service Center of Shanghai, Zhuanqiao Community Health Service Center of Shanghai, Maqiao Community Health Service Center of Shanghai, Wujing Community Health Service Center of Shanghai, Pujiang Community Health Service Center of Shanghai
- Responsible party
- Principal investigator, Changlin Mei, Shanghai Changzheng Hospital
- Investigators
- Changlin Mei, Master, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084172
- Sponsor's protocol ID
- CZKIPLA-CKD-001
- Acronym
- SCREENING
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Redesign and Demonstration for Early Detection, Evaluation and Management of Chronic Kidney Disease in Shanghai
- ClinicalTrials.gov ID
- NCT03084172
- Acronym / sponsor ID
- SCREENING / CZKIPLA-CKD-001
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000,000 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Commission of Health and Family Planning, Shanghai Municipal Center for Disease Control and Prevention, Huashan Hospital, Shanghai Minhang District Municipal Center for Disease Control and Prevention, Shanghai Jing'an District Municipal Center for Disease Control and Prevention, Fudan University, Minhang District Central Hospital of Shanghai, Jing'an District Central Hospital of Shanghai, Jing'an District Zhabei Central Hospital of Shanghai, Jing'an District Shibei Hospital of Shanghai, Linfen Community Health Services Center of Shanghai, Pengpu Community Health Services Center of Shanghai, Pengpu zhen Community Health Services Center of Shanghai, Da'ning Community Health Services Center of Shanghai, Gonghexin Community Health Service Center of Shanghai, Zhijiangxi Road Community Health Service Center of Shanghai, Tianmuxi Road Community Health Service Center of Shanghai, Beizhan Community Health Service Center of Shanghai, Baoshan Community Health Services Center of Shanghai, West Nanjing road Community Health Services Center of Shanghai, Second Shimen Road Community Health Service Center of Shanghai, Jiangning Road Community Health Service Center of Shanghai, Caojiadu Community Health Service Center of Shanghai, Jing'an Temple Community Health Service Center of Shanghai, Xinzhuang Community Health Service Center of Shanghai, Longbai Community Health Service Center of Shanghai, Gumei Community Health Service Center of Shanghai, Xinhong Community Health Service Center of Shanghai, Huacao Community Health Service Center of Shanghai, Hongqiao Community Health Service Center of Shanghai, Qibao Community Health Service Center of Shanghai, Meilong Community Health Service Center of Shanghai, Jiangchuan Community Health Service Center of Shanghai, Zhuanqiao Community Health Service Center of Shanghai, Maqiao Community Health Service Center of Shanghai, Wujing Community Health Service Center of Shanghai, Pujiang Community Health Service Center of Shanghai
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 20 Mar 2017 (actual)
- 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.
Based on clinical evidence based medicine and organizational management model, investigators redesign the prevention and treatment of chronic kidney disease of public health system in Shanghai China. The investigators hope to find early chronic kidney disease, prevention and clinical intervention of orderly combination. The advantages of this system were confirmed by comparing the prevalence rate, awareness rate and treatment rate before and after the completion of the system.
Detailed description
The whole study mainly includes the following parts:
- Establishment of a database of patients with kidney disease, and training data entry specialist in every center.
- Conduct propaganda of kidney disease knowledge, training professional doctors in center hospital and community hospital.
- Search for high-risk patients, and screening for patients with kidney disease from community residents in community hospital.
- Establishment of a standardized and orderly patient referral process from community hospital to center hospital or three level of first-class hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic kidney disease patients group | – | –These patients were screened from 2000000 of the population. The investigator will compare the prevalence rate, awareness rate and treatment rate before and after the completion of the system. The degree of decreased glomerular filtration rate is also an important evaluation index. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The residents in Jing'an District and Minhang District, which medical services are provided by those collaborative Community Health Service Center.
Key inclusion criteria (2 listed)
- Over 18 years of age.
- Signed informed consent
Key exclusion criteria (1 listed)
- Refused to accept the blood and urine test
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
prevalence rate of chronic kidney disease
Time frame: baseline and 12 months, an average of 3 years
Change in prevalence rate of chronic kidney disease in shanghai from baseline to 3 years.
awareness rate of chronic kidney disease
Time frame: baseline and 12 months, an average of 3 years
Change in awareness rate of chronic kidney disease in shanghai from baseline to 3 years.
treatment rate of chronic kidney disease
Time frame: baseline and 12 months, an average of 3 years
Change in using standardized and orderly patient referral process from community hospital to center hospital or three level of first-class hospital. in shanghai from baseline to 3 years.
The degree of decreased glomerular filtration rate in chronic kidney patients
Time frame: through study completion, an average of 3 years
The degree of decreased glomerular filtration rate in chronic kidney patients, compared with healthy people and reported level in the literatures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Changlin Mei, Master principal investigator
Shanghai Changzheng Hospital
34 sites 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 Diseases, run by Shanghai Changzheng Hospital at 34 sites in China.
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 2 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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. 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?
Contact xiao Qin, Master (+8615800493668, sunnyqinxiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence rate of chronic kidney disease (time frame: baseline and 12 months, an average of 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 24 Mar 2017.