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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03246191
Other study ID # 2015BAI12B06-2
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 May 2018

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, cross-sectional study aimed at screening and accessing risk factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment and other complications in the CKD patients. To develop biomarkers of CKD.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 900
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age=18 years

- clinical diagnosis of CKD

- signed informed consent

Exclusion Criteria:

- End-stage renal disease(ESRD) or dialysis

- Acute kidney injure(AKI)

- history of solid organ or bone marrow transplantation

- active malignancy within 24 months prior to screening or metastatic cancer

- HIV infection or AIDS

- acute inflammation

Study Design


Intervention

Other:
blood sample collection
blood sample collection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of CKD complications hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment baseline
Primary Biomarkers of kidney function baseline
Secondary Genetic analyses circulating microRNA baseline
Secondary Questionnaire assessing cognitive function Montreal Cognitive Assessment-Basic Chinese Version baseline
Secondary Questionnaire assessing depression Beck Depression Inventory scores baseline
Secondary Questionnaire assessing risk of malnutrition Malnutrition-Inflammation Score baseline
Secondary Questionnaire assessing dietary intake Food Frequency Questionnaire baseline
Secondary Questionnaire assessing quality of life Activity of daily living(ADL)and kidney disease quality of life (KDQOLTM-36) baseline
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