Lupus NephritisNCT03001973
High Quality Evidence of Chinese Lupus Nephritis (HELP)
An observational study of Lupus Nephritis, run by Sun Yat-sen University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Lupus Nephritis
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lupus nephritis patients
Who may be able to join
- Patients who diagnosis as lupus nephritis
Who cannot join
- No
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xueqing Yu, M.D. & Ph.D contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Xueqing Yu, M.D. & Ph.D., yuxq@mail.sysu.edu.cn
About this study
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.
- Conditions
- Lupus Nephritis
- Being tested
- No Intervention
- Keywords
- Lupus nephritis, Patient survival, Renal survival
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LN patients | Patients diagnosis as lupus nephritis Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality and cardiovascular mortality of LN patients
Measured: 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).
Measured: 10years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startNov 2013
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001973
- Sponsor's protocol ID
- HELP
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2016
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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 35712095Yin 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Quality Evidence of Chinese Lupus Nephritis (HELP)
- ClinicalTrials.gov ID
- NCT03001973
- Acronym / sponsor ID
- HELP
- Conditions
- Lupus Nephritis
- Keywords
- Lupus nephritis, Patient survival, Renal survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LN patients | – | Other: No InterventionPatients diagnosis as lupus nephritis |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lupus nephritis patients
Key inclusion criteria (1 listed)
- Patients who diagnosis as lupus nephritis
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionRegistration of all LN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China. | Other | LN patients |
Primary outcome
All-cause mortality and cardiovascular mortality of LN patients
Time frame: 10years
A composite renal outcome of LN patients
Time frame: 10years
The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 35712095Tian 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.
- Derived from this study: PubMed 29212518Yin 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xueqing Yu, M.D. & Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueqing Yu, M.D. & Ph.D (yuxq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality and cardiovascular mortality of LN patients (time frame: 10years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03001973, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.