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RecruitingNCT03001973Updated Sep 15, 2026

High Quality Evidence of Chinese Lupus Nephritis (HELP)

An observational study in Lupus Nephritis, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
14 Years and older
Sex
All
01

Study 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.

Read the detailed description

The investigators are registering Lupus nephritis (LN) and developing a LN database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education etc.), clinical characteristics (including systolic blood pressure, diastolic blood pressure, and lab measurements of whole blood, serum, urine etc.), complications, drug information at the baseline will be collected. Patients will be follow-up every year, the demographic and clinical characteristics, complications; drug information of patients will be collected at each visit. We will also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), end-stage renal disease (ESRD) or serum creatinine doubling. The patient survival and renal survival will be compared using the LN database.

02

Conditions studied

  • Lupus Nephritis

Browse trials for

Keywords

  • Lupus nephritis
  • Patient survival
  • Renal survival
03

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Lupus nephritis patients

Inclusion criteria

  • Patients who diagnosis as lupus nephritis

Exclusion criteria

Exclusion Criteria:

  • No
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • LN patients

    Patients diagnosis as lupus nephritis

    Other: No Intervention

Interventions

  • OtherNo Intervention

    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.

05

What researchers measure

Primary outcomes

  1. All-cause mortality and cardiovascular mortality of LN patients

    Time frame: 10years

  2. 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).

    Time frame: 10years

06

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 35712095 ↗
  • Yin 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. PubMed 29212518 ↗

Individual participant data

Plan to share: Yes

08

Registry details

Key details

Study ID
NCT03001973
Lead sponsor
Sun Yat-sen University
Responsible party
Xue Qing Yu (Professor, Sun Yat-sen University) — Principal investigator
First posted
Dec 23, 2016
Start date
Nov 2013
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 15, 2026

Study contacts

Xueqing Yu, M.D. & Ph.D
Contact
yuxq@mail.sysu.edu.cn
Wei Chen, M.D. & Ph.D
Contact
vvchen66@qq.com
8620-87755766 ext. 8843

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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