NCT03711617

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

6.7 years

First QC Date

October 16, 2018

Last Update Submit

November 27, 2024

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney diseaseuremic toxinprognosis

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    5 years

Secondary Outcomes (1)

  • comorbidities

    5 years

Study Arms (2)

CKD-ND

patients with non-dialysis CKD

CKD-MHD

patients with maintenance hemodialysis

Eligibility Criteria

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

CKD patients from hospitals

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine,serum

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

  • Feng Ding, PhD

    Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

    STUDY CHAIR

Central Study Contacts

Feng Ding, PhD

CONTACT

86-21-53315165dingfeng@sjtu.edu.cn

Wenji Wang, MD

CONTACT

86-21-53315165wangwj1736@sh9hospital.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Devision of Nephrology

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 18, 2018

Study Start

May 1, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations

CN(1)