Chronic Kidney Disease Clinical Trial
Official title:
Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)
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.
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | February 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital | Beijing Friendship Hospital, China-Japan Friendship Hospital, First Affiliated Hospital, Sun Yat-Sen University, Fudan University, Hebei Medical University Third Hospital, RenJi Hospital, Renmin Hospital of Wuhan University, Second Hospital of Jilin University, Shandong Provincial Hospital, The First Affiliated Hospital of Dalian Medical University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death | 5 year | ||
Primary | 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 | 5 year | |
Primary | eGFR decline=40% | 5 year | ||
Secondary | Acute coronary syndrome | 5 year | ||
Secondary | Heart failure | 5 year | ||
Secondary | Cerebral stroke | 5 year | ||
Secondary | Peripheral arterial disease | 5 year |
Status | Clinical Trial | Phase | |
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