High Quality Evidence of Guangzhou Lupus Nephritis Cohort... | NCT06682507

Studies
High Quality Evidence of Guangzhou Lupus Nephritis Cohort (HOPE Cohort)

NCT06682507

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Recruiting

Last Update Posted

Nov 12, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Lupus Nephritis (LN)

Interventions

No Intervention: Observational Cohort

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

Jan 1, 1996Actual

Primary Completion Date

Dec 31, 2050Estimated

Completion Date

Dec 31, 2050Estimated

First Submitted Date

Nov 1, 2024

First Submission Date that Met QC Criteria

Nov 8, 2024

First Posted Date

Nov 12, 2024Actual

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 8, 2024

Last Update Posted Date

Nov 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wei Chen, Director of Department of Nephrology, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the long-term renal and patient's survival of lupus nephritis (LN) patients in China. The main question it aims to answer is:

Does the renal and patient's survival improved in the long term period? Participants who had renal biopsy proven lupus nephritis in one hospital will be followed up.

Detailed Description

Patients from 1996-2016 were retrospective enrolled and patients starting from 2017 were prespective enrolled

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention: Observational Cohort	Other	No Intervention: Observational Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of patients with end stage renal disease	End stage renal disease	From data of enrollment until the data of first documented end stage renal disease, assessed up to 50 years

Secondary Outcomes

Measure	Description	Time Frame
Rate of patient's mortality	death	From data of enrollment until the data of death, assessed up to 50 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who had biopsy proven lupus nephritis in The First Affiliated Hospital of Sun Yat-sen University

Exclusion Criteria:

less than 14 years old
refused to give written consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who had biopsy proven lupus nephritis in The First Affiliated Hospital of Sun Yat-sen University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xi Xia, MD PHD	Contact	+8618825134511		xiax29@mail.sysu.edu.cn
Ruihan Tang, MD PHD	Contact	+8618998472466		tangrh8@mail.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Wei Chen, MD PHD	First Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510080	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Individual participant data may contain privacy.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008181	Lupus Nephritis
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided