NCT03001921

Brief Summary

The investigators are registering all HD patients at recruited hospitals and developing a HD database in China. Patients will be follow-up every 3 months, and both baseline and follow-up information will be entered into the registration system. The patient survival, technical survival, patency rate of access, quality of life and residual renal function for HD patients will be compared using the HD database.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Dec 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Dec 2013Dec 2027

Study Start

First participant enrolled

December 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

13 years

First QC Date

December 21, 2016

Last Update Submit

October 20, 2020

Conditions

Haemolyses and Related Conditions

Keywords

HemodialysisPatient survivalQuality of lifeHemodialysis access

Outcome Measures

Primary Outcomes (1)

  • Patient survival of HD patients

    10 years

Secondary Outcomes (2)

  • Quality of life evaluated using SF36 scale for HD patients

    10 years

  • Patency rate of access for HD patients

    10 years

Study Arms (1)

Hemodialysis patients

End stage renal disease patients receiving hemodialysis treatment

Other: No intervention

Interventions

No interventionOTHER

Registration of all HD patients in the First Affiliated Hospital of Sun Yat-sen University and other hospital which have signed the contract in China.

Hemodialysis patients

Eligibility Criteria

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

End stage renal disease patients receiving hemodialysis treatment

You may qualify if:

  • End stage renal disease patients receiving hemodialysis treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

he serum, urine, and DNA will be collected.

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xueqing Yu, M.D. & Ph.D.

CONTACT

yuxq@mail.sysu.edu.cn

Xunhua Zheng, M.D. & Ph.D.

CONTACT

wilson_zxh@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 23, 2016

Study Start

December 1, 2013

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Locations

CN(1)