Chronic Kidney DiseaseNCT03246191
Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Chinese PLA General Hospital.
Trial summary
The study is an observational, cross-sectional study aimed at screening and accessing risk factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition（PEM）, cognitive impairment and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- blood sample collection
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to May 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
- No healthy volunteers
- Adult, Older adult
Study population: subjects with 18 years or older
Who may be able to join
- age≥18 years
- clinical diagnosis of CKD
- signed informed consent
Who cannot join
- End-stage renal disease(ESRD) or dialysis
- Acute kidney injure(AKI)
- history of solid organ or bone marrow transplantation
- active malignancy within 24 months prior to screening or metastatic cancer
- HIV infection or AIDS
- acute inflammation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease：a Cross - Sectional Study
The study is an observational, cross-sectional study aimed at screening and accessing risk factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To develop biomarkers of CKD.
- Conditions
- Chronic Kidney Disease
- Being tested
- blood sample collection
- 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.
blood sample collectionOther
blood sample collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CKD complications
hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment
Measured: baseline
Biomarkers of kidney function
Measured: baseline
Secondary outcomes (6)
Genetic analyses
circulating microRNA
Measured: baseline
Questionnaire assessing cognitive function
Montreal Cognitive Assessment-Basic Chinese Version
Measured: baseline
Questionnaire assessing depression
Beck Depression Inventory scores
Measured: baseline
Questionnaire assessing risk of malnutrition
Malnutrition-Inflammation Score
Measured: baseline
Questionnaire assessing dietary intake
Food Frequency Questionnaire
Measured: baseline
Questionnaire assessing quality of life
Activity of daily living（ADL）and kidney disease quality of life （KDQOLTM-36）
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study startAug 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionMay 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 DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiangmei, Chinese PLA General Hospital
- Investigators
- xiangmei chen, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246191
- Sponsor's protocol ID
- 2015BAI12B06-2
- Status last verified
- Aug 2017
- First submitted
- 13 Jun 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease：a Cross - Sectional Study
- ClinicalTrials.gov ID
- NCT03246191
- Acronym / sponsor ID
- 2015BAI12B06-2
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 11 Aug 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.
The study is an observational, cross-sectional study aimed at screening and accessing risk factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To develop biomarkers of CKD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with 18 years or older
Key inclusion criteria (3 listed)
- age≥18 years
- clinical diagnosis of CKD
- signed informed consent
Key exclusion criteria (6 listed)
- End-stage renal disease(ESRD) or dialysis
- Acute kidney injure(AKI)
- history of solid organ or bone marrow transplantation
- active malignancy within 24 months prior to screening or metastatic cancer
- HIV infection or AIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample collectionblood sample collection | Other | – |
Primary outcome
Prevalence of CKD complications
Time frame: baseline
hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment
Biomarkers of kidney function
Time frame: baseline
6 secondary outcomes
Genetic analyses
Time frame: baseline
Questionnaire assessing cognitive function
Time frame: baseline
Questionnaire assessing depression
Time frame: baseline
Questionnaire assessing risk of malnutrition
Time frame: baseline
Questionnaire assessing dietary intake
Time frame: baseline
Questionnaire assessing quality of life
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
xiangmei chen principal investigator
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Chinese PLA General Hospital.
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 6 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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 guangyan cai (00861066935462, caiguangyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CKD complications (time frame: baseline). The study lists 2 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 11 Aug 2017.