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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03246204
Other study ID # 2015BAI12B06
Secondary ID
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
Health authority
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

Study Design


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
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