NCT03246191

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

June 13, 2017

Last Update Submit

August 8, 2017

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

  • Prevalence of CKD complications

    hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition(PEM), cognitive impairment

    baseline

  • Biomarkers of kidney function

    baseline

Secondary Outcomes (6)

  • Genetic analyses

    baseline

  • Questionnaire assessing cognitive function

    baseline

  • Questionnaire assessing depression

    baseline

  • Questionnaire assessing risk of malnutrition

    baseline

  • Questionnaire assessing dietary intake

    baseline

  • +1 more secondary outcomes

Interventions

blood sample collectionOTHER

blood sample collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

subjects with 18 years or older

You may qualify if:

  • age≥18 years
  • clinical diagnosis of CKD
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

serum, whole blood，urine

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • xiangmei chen

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

guangyan cai

CONTACT

00861066935462caiguangyan@sina.com

wenling wang

CONTACT

008618600258258wangwenlingczyy@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academician of Chinese Academy of Engineering

Study Record Dates

First Submitted

June 13, 2017

First Posted

August 11, 2017

Study Start

August 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share