Chinese Observational Prospective Study of Aging Populati... | NCT03246204

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

NCT03246204

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Aug 11, 2017Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Chronic Kidney Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2017Estimated

Primary Completion Date

Feb 2023Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Jun 13, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2017

Last Update Posted Date

Aug 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Xiangmei, Academician of Chinese Academy of Engineering, Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Name	Class
First Affiliated Hospital, Sun Yat-Sen University	OTHER
Fudan University	OTHER
China-Japan Friendship Hospital	OTHER
The First Affiliated Hospital of Dalian Medical University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Acute coronary syndrome		5 year
Heart failure		5 year
Cerebral stroke

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

subjects with 65 years or older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
guangyan cai	Contact	00861066935462		caiguangyan@sina.com
shuang liang	Contact	008615110246423		liangshuang301@163.com

Overall Officials

Name	Affiliation	Role
xiangmei chen	Chinese PLA General Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29478020	Derived	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.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases