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

August 8, 2017 updated by: Chen Xiangmei, Chinese PLA General Hospital
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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

subjects with 65 years or older

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 5 year
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
5 year
eGFR decline≥40%
Time Frame: 5 year
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute coronary syndrome
Time Frame: 5 year
5 year
Heart failure
Time Frame: 5 year
5 year
Cerebral stroke
Time Frame: 5 year
5 year
Peripheral arterial disease
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

Fudan University
Beijing Friendship Hospital
First Affiliated Hospital, Sun Yat-Sen University
RenJi Hospital
Shandong Provincial Hospital
China-Japan Friendship Hospital
Renmin Hospital of Wuhan University
Hebei Medical University Third Hospital
Second Hospital of Jilin University
The First Affiliated Hospital of Dalian Medical University

Investigators

  • Principal Investigator: Xiangmei Chen, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2017

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015BAI12B06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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