Uremic Toxins and Outcomes in Chronic Kidney Disease | NCT03711617

Studies
Uremic Toxins and Outcomes in Chronic Kidney Disease

NCT03711617

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Status

Recruiting

Last Update Posted

Dec 3, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Chronic Kidney Diseases

Interventions

Not provided

Countries

China

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

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 16, 2018

First Submission Date that Met QC Criteria

Oct 16, 2018

First Posted Date

Oct 18, 2018Actual

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

Nov 27, 2024

Last Update Posted Date

Dec 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ding Feng, Director of Devision of Nephrology, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityPrincipal Investigator

Lead Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of this cohort study is:

To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.

Detailed Description

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD-ND		patients with non-dialysis CKD
CKD-MHD		patients with maintenance hemodialysis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause mortality		5 years

Secondary Outcomes

Measure	Description	Time Frame
comorbidities	CVD,mortality,hospitalization	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥18 years old;
clinically diagnosed with chronic kidney disease, according K/DOQI criteria.

Exclusion Criteria:

acute kidney injury
history of kidney injury <3 months
malignancy
pregnancy
incomplete clinical data

Accepts Healthy Volunteers

Yes

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

CKD patients from hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Feng Ding, PhD	Contact	86-21-53315165		dingfeng@sjtu.edu.cn
Wenji Wang, MD	Contact	86-21-53315165		wangwj1736@sh9hospital.org

Overall Officials

Name	Affiliation	Role
Feng Ding, PhD	Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Ninth People's Hospital	Recruiting	Shanghai	Shanghai Municipality	200011	China

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