NCT06682507

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
301mo left

Started Jan 1996

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 Progress55%
Jan 1996Dec 2050

Study Start

First participant enrolled

January 1, 1996

Completed
28.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
26.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

55 years

First QC Date

November 1, 2024

Last Update Submit

November 8, 2024

Conditions

Keywords

lupuslupus nephritisoutcomesend stage kidney disease

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Rate of patient's mortality

    From data of enrollment until the data of death, assessed up to 50 years

Interventions

No Intervention: Observational Cohort

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • less than 14 years old
  • refused to give written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Renal tissue from renal biopsy, urine, serum, DNA, PBMC, stool.

MeSH Terms

Conditions

Lupus NephritisKidney Failure, Chronic

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wei Chen, MD PHD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Nephrology

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 12, 2024

Study Start

January 1, 1996

Primary Completion (Estimated)

December 31, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations