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

August 8, 2017 updated by: Chen Xiangmei, Chinese PLA General Hospital

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: baseline
hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment
baseline
Biomarkers of kidney function
Time Frame: baseline
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Xiangmei Chen, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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