Screening and Assessing the Risk Factors and Complication... | NCT03246191

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

NCT03246191

Sponsor

Chinese PLA General Hospital

Status

Unknown status

Last Update Posted

Aug 11, 2017Actual

Enrollment

900Estimated

Phase

Not provided

Conditions

Chronic Kidney Disease

Interventions

blood sample collection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2017Estimated

Primary Completion Date

May 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

Jun 13, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2017

Last Update Posted Date

Aug 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Xiangmei, Academician of Chinese Academy of Engineering, Chinese PLA General HospitalPrincipal Investigator

Lead Sponsor

Chinese PLA General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

900Estimated

Name	Type	Description	Arm Group Labels	Other Names
blood sample collection	Other	blood sample collection

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Genetic analyses	circulating microRNA	baseline
Questionnaire assessing cognitive function	Montreal Cognitive Assessment-Basic Chinese Version

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

subjects with 18 years or older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
guangyan cai	Contact	00861066935462		caiguangyan@sina.com
wenling wang	Contact	008618600258258		wangwenlingczyy@163.com

Overall Officials

Name	Affiliation	Role
xiangmei chen	Chinese PLA General Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided