Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease

Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease：a Cross - Sectional Study

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: blood sample collection

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects with 18 years or older

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of CKD complications	hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment	baseline
Biomarkers of kidney function		baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic analyses	circulating microRNA	baseline
Questionnaire assessing cognitive function	Montreal Cognitive Assessment-Basic Chinese Version	baseline
Questionnaire assessing depression	Beck Depression Inventory scores	baseline
Questionnaire assessing risk of malnutrition	Malnutrition-Inflammation Score	baseline
Questionnaire assessing dietary intake	Food Frequency Questionnaire	baseline
Questionnaire assessing quality of life	Activity of daily living（ADL）and kidney disease quality of life （KDQOLTM-36）	baseline

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Xiangmei Chen, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2015BAI12B06-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No