Chronic Kidney DiseaseNCT03246204
Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)
An observational study of Chronic Kidney Disease, run by Chinese PLA General Hospital.
Trial summary
The study is an observational, multicenter, prospective cohort study aimed at evaluating a 5-year screening programme for chronic kidney disease(CKD) in a population of elderly patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum, the incidence of complications and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Feb 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: subjects with 65 years or older
Who may be able to join
- age≥65 years
- clinical diagnosis of CKD
- signed informed consent
Who cannot join
- subjects who have a poor compliance and cannot be scheduled for follow-up
- subjects participating in other interventional clinical trials
- ESRD or dialysis
- Acute kidney injury(AKI)
- history of solid organ or bone marrow transplantation
- active malignancy within 24 months prior to screening or metastatic cancer
Show all 11Show fewer
- life expectancy less than 6 months；
- severe cognitive impairment（NYHA III or IV）
- HIV infection or AIDS
- subjects cannot be able to complete the assessment including dementia or other mental disorders, limited physical activity, severe visual impairment
- simple hematuria
Trial locations and contacts
No sites are listed yet.
About this study
The study is an observational, multicenter, prospective cohort study aimed at evaluating a 5-year screening programme for chronic kidney disease(CKD) in a population of elderly patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum, the incidence of complications and co-morbidities.To assess the correlation between daily living ability, mental and physical function, quality of life, nutritional status and prognosis.To develop biomarkers of renal aging.
- Conditions
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 5 year
Incidence of End Stage Renal Disease (ESRD)
ESRD will be defined as estimated glomerular filtration rate(eGFR)<15 mL/min/1.73 m2 or dialysis
Measured: 5 year
eGFR decline≥40%
Measured: 5 year
Secondary outcomes (4)
Acute coronary syndrome
Measured: 5 year
Heart failure
Measured: 5 year
Cerebral stroke
Measured: 5 year
Peripheral arterial disease
Measured: 5 year
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 completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Fudan University, China-Japan Friendship Hospital, The First Affiliated Hospital of Dalian Medical University, Shandong Provincial Hospital, Beijing Friendship Hospital, RenJi Hospital, Hebei Medical University Third Hospital, Second Hospital of Jilin University, Renmin Hospital of Wuhan University
- 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
- NCT03246204
- Sponsor's protocol ID
- 2015BAI12B06
- Status last verified
- Aug 2017
- First submitted
- 13 Jun 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liang S, Wang WL, Zhu FL, Duan SW, Sun XF, Chen XM, Cai GY; Chinese observational prospective study of ageing population with chronic kidney disease (C-OPTION). Chinese observational prospective study of ageing population with chronic kidney disease (C-OPTION): a study protocol. BMJ Open. 2018 Feb 24;8(2):e019457. doi: 10.1136/bmjopen-2017-019457.
PubMed 29478020
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
- Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)
- ClinicalTrials.gov ID
- NCT03246204
- Acronym / sponsor ID
- 2015BAI12B06
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Fudan University, China-Japan Friendship Hospital, The First Affiliated Hospital of Dalian Medical University, Shandong Provincial Hospital, Beijing Friendship Hospital, RenJi Hospital, Hebei Medical University Third Hospital, Second Hospital of Jilin University, Renmin Hospital of Wuhan University
- Study start
- Aug 2017 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (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, multicenter, prospective cohort study aimed at evaluating a 5-year screening programme for chronic kidney disease(CKD) in a population of elderly patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum, the incidence of complications and co-morbidities.To assess the correlation between daily living ability, mental and physical function, quality of life, nutritional status and prognosis.To develop biomarkers of renal aging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- subjects with 65 years or older
Key inclusion criteria (3 listed)
- age≥65 years
- clinical diagnosis of CKD
- signed informed consent
Key exclusion criteria (11 listed)
- subjects who have a poor compliance and cannot be scheduled for follow-up
- subjects participating in other interventional clinical trials
- ESRD or dialysis
- Acute kidney injury(AKI)
- history of solid organ or bone marrow transplantation
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
Death
Time frame: 5 year
Incidence of End Stage Renal Disease (ESRD)
Time frame: 5 year
ESRD will be defined as estimated glomerular filtration rate(eGFR)<15 mL/min/1.73 m2 or dialysis
eGFR decline≥40%
Time frame: 5 year
4 secondary outcomes
Acute coronary syndrome
Time frame: 5 year
Heart failure
Time frame: 5 year
Cerebral stroke
Time frame: 5 year
Peripheral arterial disease
Time frame: 5 year
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.
- Derived from this study: PubMed 29478020Liang S, Wang WL, Zhu FL, Duan SW, Sun XF, Chen XM, Cai GY; Chinese observational prospective study of ageing population with chronic kidney disease (C-OPTION). Chinese observational prospective study of ageing population with chronic kidney disease (C-OPTION): a study protocol. BMJ Open. 2018 Feb 24;8(2):e019457. doi: 10.1136/bmjopen-2017-019457.
- 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 11 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?
Death (time frame: 5 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246204, which also lists 1 linked publication.
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.