Lupus Nephritis (LN)HOPENCT06682507
High Quality Evidence of Guangzhou Lupus Nephritis Cohort (HOPE Cohort)
An observational study of Lupus Nephritis (LN), run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Lupus Nephritis (LN)
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 1996to 31 Dec 2050
- How long will I take part?
- 30 Years
- 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: Patients who had biopsy proven lupus nephritis in The First Affiliated Hospital of Sun Yat-sen University
Who may be able to join
- Patients who had biopsy proven lupus nephritis in The First Affiliated Hospital of Sun Yat-sen University
Who cannot join
- less than 14 years old
- refused to give written consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Xi Xia, MD PHD, +8618825134511, xiax29@mail.sysu.edu.cn
Ruihan Tang, MD PHD, +8618998472466, tangrh8@mail.sysu.edu.cn
About this study
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.
Read the detailed description
Patients from 1996-2016 were retrospective enrolled and patients starting from 2017 were prespective enrolled
- Conditions
- Lupus Nephritis (LN)
- Being tested
- No Intervention: Observational Cohort
- Keywords
- lupus, lupus nephritis, outcomes, end stage kidney disease
- Medical subject headings
- Lupus Nephritis, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with end stage renal disease
End stage renal disease
Measured: 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
death
Measured: From data of enrollment until the data of death, assessed up to 50 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jan 1996
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, 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
- Other
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Chen, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Wei Chen, MD PHD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682507
- Sponsor's protocol ID
- FirstSunYetSen2016-215
- Acronym
- HOPE
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may contain privacy.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Quality Evidence of Guangzhou Lupus Nephritis Cohort (HOPE Cohort)
- ClinicalTrials.gov ID
- NCT06682507
- Acronym / sponsor ID
- HOPE / FirstSunYetSen2016-215
- Conditions
- Lupus Nephritis (LN)
- Keywords
- lupus, lupus nephritis, outcomes, end stage kidney disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 1996 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 12 Nov 2024 (actual)
- 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 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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had biopsy proven lupus nephritis in The First Affiliated Hospital of Sun Yat-sen University
Key inclusion criteria (1 listed)
- Patients who had biopsy proven lupus nephritis in The First Affiliated Hospital of Sun Yat-sen University
Key exclusion criteria (2 listed)
- less than 14 years old
- refused to give written consent
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 Intervention: Observational CohortNo Intervention: Observational Cohort | Other | – |
Primary outcome
Rate of patients with end stage renal disease
Time frame: From data of enrollment until the data of first documented end stage renal disease, assessed up to 50 years
End stage renal disease
1 secondary outcome
Rate of patient's mortality
Time frame: From data of enrollment until the data of death, assessed up to 50 years
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 12 Nov 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data may contain privacy.
Related trials for Lupus Nephritis (LN)
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
RecruitingPhase 2
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Lupus Nephritis
RecruitingPhase 1
Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis
Lupus Nephritis (LN)
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.
Wei Chen, MD PHD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
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 (LN), run by First Affiliated Hospital, 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 2 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 12 Nov 2024. 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 Xi Xia, MD PHD (+8618825134511, xiax29@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with end stage renal disease (time frame: From data of enrollment until the data of first documented end stage renal disease, assessed up to 50 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.