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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03246204
• Other study ID #: 2015BAI12B06
• Status: Not yet recruiting
• Phase: N/A
• First received: June 13, 2017
• Last updated: August 8, 2017
• Start date: August 2017
• Est. completion date: February 2023

Study information

• Verified date: August 2017
• Source: Chinese PLA General Hospital
• Contact: guangyan cai
• Phone: 00861066935462
• Email: caiguangyan[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (11)

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

Outcome

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