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Clinical Trials/NCT03246204
NCT03246204
Unknown
N/A

Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)

Chinese PLA General Hospital0 sites3,000 target enrollmentAugust 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
Chinese PLA General Hospital
Enrollment
3000
Primary Endpoint
Death
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2017
End Date
February 2023
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Chen Xiangmei

Academician of Chinese Academy of Engineering

Chinese PLA General Hospital

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Heart failure(5 year)
  • Acute coronary syndrome(5 year)
  • Peripheral arterial disease(5 year)
  • Cerebral stroke(5 year)

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