High Quality Evidence of Chinese Lupus Nephritis (HELP)
1 other identifier
observational
5,000
1 country
1
Brief Summary
The investigators are registering LN patients at recruited hospitals and developing a LN database in China. Patients will be follow-up every year, and both baseline and follow-up information will be entered into the registration system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
1 active site
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 Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
October 22, 2020
October 1, 2020
13.1 years
December 21, 2016
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
All-cause mortality and cardiovascular mortality of LN patients
10years
A composite renal outcome of LN patients
The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).
10years
Study Arms (1)
LN patients
Patients diagnosis as lupus nephritis
Interventions
Registration of all LN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.
Eligibility Criteria
Lupus nephritis patients
You may qualify if:
- Patients who diagnosis as lupus nephritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Related Publications (2)
Tian N, Zhou Q, Yin P, Chen W, Hong L, Luo Q, Chen M, Yu X, Chen W. Long-Term Kidney Prognosis and Pathological Characteristics of Late-Onset Lupus Nephritis. Front Med (Lausanne). 2022 May 30;9:882692. doi: 10.3389/fmed.2022.882692. eCollection 2022.
PMID: 35712095DERIVEDYin P, Zhou Y, Li B, Hong L, Chen W, Yu X. Effect of low and high HDL-C levels on the prognosis of lupus nephritis patients: a prospective cohort study. Lipids Health Dis. 2017 Dec 6;16(1):232. doi: 10.1186/s12944-017-0622-3.
PMID: 29212518DERIVED
Biospecimen
The serum, urine, DNA and renal tissue will be collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- 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
November 1, 2013
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
October 22, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share