NCT03246204

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

5.5 years

First QC Date

June 13, 2017

Last Update Submit

August 8, 2017

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (3)

  • Death

    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

    5 year

  • eGFR decline≥40%

    5 year

Secondary Outcomes (4)

  • Acute coronary syndrome

    5 year

  • Heart failure

    5 year

  • Cerebral stroke

    5 year

  • Peripheral arterial disease

    5 year

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects with 65 years or older

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29478020DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, whole blood，urine

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • xiangmei chen

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

guangyan cai

CONTACT

00861066935462caiguangyan@sina.com

shuang liang

CONTACT

008615110246423liangshuang301@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academician of Chinese Academy of Engineering

Study Record Dates

First Submitted

June 13, 2017

First Posted

August 11, 2017

Study Start

August 1, 2017

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share