Clinical trial NCT03246204: Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)
Official title: Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Fudan University
name: China-Japan Friendship Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: Shandong Provincial Hospital
name: Beijing Friendship Hospital
name: RenJi Hospital
name: Hebei Medical University Third Hospital
name: Second Hospital of Jilin University
name: Renmin Hospital of Wuhan University
First posted: 2017-08-11
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with 65 years or older

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* age≥65 years
* clinical diagnosis of CKD
* signed informed consent

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Death
timeFrame: 5 year
measure: Incidence of End Stage Renal Disease (ESRD)
timeFrame: 5 year
measure: eGFR decline≥40%
timeFrame: 5 year
Secondary outcomes:
measure: Acute coronary syndrome
timeFrame: 5 year
measure: Heart failure
timeFrame: 5 year
measure: Cerebral stroke
timeFrame: 5 year
measure: Peripheral arterial disease
timeFrame: 5 year
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: xiangmei chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.