Lupus NephritisNCT07031674
Comparing Efficacy and Safety of Telitacicept and Belimumab in Lupus Nephritis: A Retrospective Multicenter Cohort Study.
An observational study of Lupus Nephritis and Belimumab, run by Yipeng Liu at 1 site in China.
Trial summary
The objective of this observational study is to compare the efficacy and safety of telitacicept and belimumab in the treatment of lupus nephritis in patients aged 18-65 years with lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis, Belimumab
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The inclusion period is from March 1, 2021 to March 1, 2024. Patients who visited the First Affiliated Hospital of Shandong University Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Wuhan University People's Hospital, and the Department of Nephrology of Capital Medical University Affiliated Beijing Friendship Hospital for clinical diagnosis of lupus nephritis were included.
Who may be able to join
- Age range: 18 - 65 years old;
- Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
- Urine protein quantification ≥ 1g/d, or urine PCR ≥ 1g/g, or qualitative urine protein test in urine routine ≥ 1+;
- Patients who have been using telitacicept or belimumab for at least 12 weeks.
Who cannot join
- Having active central nervous system diseases;
- eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
- Pregnant women, or those who are about to become pregnant in the near future, or lactating women;
- Participants who are simultaneously participating in other clinical studies;
- Patients who have received telitacicept or belimumab treatment for less than 12 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this observational study is to compare the efficacy and safety of telitacicept and belimumab in the treatment of lupus nephritis in patients aged 18-65 years with lupus nephritis. The main question it aims to answer is: What are the response rates of the two drugs for the main renal therapy in the lupus nephritis population? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.
- Conditions
- Lupus Nephritis, Belimumab
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The Telitacicept group | The participants in the study had previously used telitacicept as a therapeutic drug. | |
| The Belimumab group | The participants in the study had previously used belimumab as a therapeutic drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate for major kidney treatments
- 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol);
- eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2;
- No rescue treatment was adopted due to treatment failure.
Measured: From baseline to the end of 1-year treatment period
Secondary outcomes (1)
Complete renal response rate
- 24-hour urine PCR < 0.5 g/g (50 mg/mmol);
- Renal function is stable or has improved (by no more than 10%-15% compared to the baseline).
Measured: From baseline to the end of 1-year treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yipeng Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Beijing Friendship Hospital
- Responsible party
- Sponsor-investigator, Yipeng Liu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031674
- Sponsor's protocol ID
- YXLL-KY-2025(102)
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy and Safety of Telitacicept and Belimumab in Lupus Nephritis: A Retrospective Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT07031674
- Acronym / sponsor ID
- YXLL-KY-2025(102)
- Conditions
- Lupus Nephritis, Belimumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yipeng LiuUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Beijing Friendship Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Jun 2025 (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 objective of this observational study is to compare the efficacy and safety of telitacicept and belimumab in the treatment of lupus nephritis in patients aged 18-65 years with lupus nephritis. The main question it aims to answer is: What are the response rates of the two drugs for the main renal therapy in the lupus nephritis population? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Telitacicept group | – | –The participants in the study had previously used telitacicept as a therapeutic drug. |
| The Belimumab group | – | –The participants in the study had previously used belimumab as a therapeutic drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion period is from March 1, 2021 to March 1, 2024. Patients who visited the First Affiliated Hospital of Shandong University Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Wuhan University People's Hospital, and the Department of Nephrology of Capital Medical University Affiliated Beijing Friendship Hospital for clinical diagnosis of lupus nephritis were included.
Key inclusion criteria (4 listed)
- Age range: 18 - 65 years old;
- Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
- Urine protein quantification ≥ 1g/d, or urine PCR ≥ 1g/g, or qualitative urine protein test in urine routine ≥ 1+;
- Patients who have been using telitacicept or belimumab for at least 12 weeks.
Key exclusion criteria (5 listed)
- Having active central nervous system diseases;
- eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
- Pregnant women, or those who are about to become pregnant in the near future, or lactating women;
- Participants who are simultaneously participating in other clinical studies;
- Patients who have received telitacicept or belimumab treatment for less than 12 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The response rate for major kidney treatments
Time frame: From baseline to the end of 1-year treatment period
1. 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol); 2. eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2; 3. No rescue treatment was adopted due to treatment failure.
1 secondary outcome
Complete renal response rate
Time frame: From baseline to the end of 1-year treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Belimumab, run by Yipeng Liu 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 2 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate for major kidney treatments (time frame: From baseline to the end of 1-year treatment period). 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 2 Feb 2026.