Lupus NephritisNCT05588830
The Efficacy and Safety of Telitacicept and Belimumab in Active Lupus Nephritis in the Real World: a Prospective Cohort Study
An observational study of Lupus Nephritis and Belimumab, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
Lupus nephritis is an autoimmune disease. It is an inflammatory kidney damage caused by the deposition of immune complexes in the kidney. It is mainly characterized by the clinical manifestations of albuminuria, hematuria, tubular urine, pyuria, and creatinine elevation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis, Belimumab, Telitacicept
- What is being tested?
- Belimumab and Telitacicept
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2022to 20 Mar 2024
- 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: Patients with lupus nephritis
Who may be able to join
- 1. Age 18 to 65 years old, gender is not limited; 2. SLE patients with a clear diagnosis, that is, in line with the SLE classification criteria revised by the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019; 3. Patients with type III and type IV (with or without type V) lupus nephritis or simple type V lupus nephritis confirmed by biopsy within 6 months of the 2003 ISN/RPS criteria; only those with biopsy specimens showing activity were recruited Patients with lesions or active and chronic lesions; 4. ANA titer ≥ 1:80 and/or anti-dsDNA antibody positive; 5. Urine protein-to-creatinine ratio (UPCR) ≥ 1.0 mg/mg (and/or equivalent 24h urine protein level); 6. The urine protein decreased by less than 25% after receiving conventional treatment for at least 3 months before enrollment; 7. Voluntarily participate in this research and sign the informed consent.
Who cannot join
- 1. eGFR<30 mL/min/1.73m2; 2. Patients requiring dialysis or kidney transplantation; 3. Patients who have received biological agents in the past; 4. Patients who have received mesenchymal stem cell therapy in the past; 5. Those who are known to be allergic to the study drug; 6. Women who are pregnant or planning to become pregnant in the near future, and women who are breastfeeding; 7. Patients with central nervous system lupus, thrombotic microangiopathy; 8. Patients who are currently suffering from active hepatitis or have a history of severe liver disease or disease; 9. Patients with immunodeficiency, uncontrolled severe infection and active or recurrent peptic ulcer; 10. Subjects who are participating in clinical research of other drugs; In addition to the above, the investigator judges that there are other reasons for not being suitable to participate in this clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Lupus nephritis is an autoimmune disease. It is an inflammatory kidney damage caused by the deposition of immune complexes in the kidney. It is mainly characterized by the clinical manifestations of albuminuria, hematuria, tubular urine, pyuria, and creatinine elevation. At present, many drugs such as glucocorticoid, immunosuppressant and belimumab are used for clinical treatment, and patients still face difficulties such as complete remission, repeated relapse and so on.
This study is a multicenter, prospective, cohort study. In the study, 60 patients with lupus nephritis were enrolled, and they were treated with Telitacicept (n=30) or belimumab (n=30) for 24 weeks on the basis of conventional treatment. To observe the effectiveness and safety of the two treatment schemes for patients.
Read more
Study drug administration method:
Telitacicept was injected subcutaneously, 160mg/time, once a week, for 24 weeks.
Belimumab, 10mg/kg, was administered intravenously on the 0, 14 and 28 days, and then once every 28 days until the 24th week During the administration period of this study, the clinician fully evaluated the safety tolerance of patients using this product and decided whether to reduce the dose. The reason for adjusting the treatment plan needs to be recorded.
Reference of routine treatment plan:
High dose hormone plus cyclophosphamide was used for induction therapy, and then azathioprine or mycophenolate mofetil was used for maintenance therapy; Or high-dose hormone plus mycophenolate mofetil is used for induction therapy, and then mycophenolate mofetil is used for maintenance therapy.
- Conditions
- Lupus Nephritis, Belimumab, Telitacicept
- Being tested
- Belimumab, Telitacicept
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelimumabDrug
Belimumab, 10mg/kg, was administered intravenously on the 0, 14 and 28 days, and then once every 28 days until the 24th week
TelitaciceptDrug
Telitacicept is injected subcutaneously, 160mg/time, once a week, for a total of 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Belimumab group | Not described Receives: Drug: Belimumab | |
| Telitacicept group | Not described Receives: Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a primary renal efficacy response (PERR)
The main renal response response (PERR) was defined as: glomerular filtration rate (eGFR) ≥ 60ml/min/1.73m2 or eGFR decreased by no more than 20% from before recurrence; Urine protein: creatinine ratio (uPCR) ≤ 0.7; It is not a treatment failure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start20 Oct 2022 (estimated)
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Mar 2024 (estimated)
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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588830
- Sponsor's protocol ID
- 2022-353-01
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Telitacicept and Belimumab in Active Lupus Nephritis in the Real World: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05588830
- Acronym / sponsor ID
- 2022-353-01
- Conditions
- Lupus Nephritis, Belimumab, Telitacicept
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Mar 2024 (estimated)
- First posted
- 20 Oct 2022 (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.
Lupus nephritis is an autoimmune disease. It is an inflammatory kidney damage caused by the deposition of immune complexes in the kidney. It is mainly characterized by the clinical manifestations of albuminuria, hematuria, tubular urine, pyuria, and creatinine elevation. At present, many drugs such as glucocorticoid, immunosuppressant and belimumab are used for clinical treatment, and patients still face difficulties such as complete remission, repeated relapse and so on.
This study is a multicenter, prospective, cohort study. In the study, 60 patients with lupus nephritis were enrolled, and they were treated with Telitacicept (n=30) or belimumab (n=30) for 24 weeks on the basis of conventional treatment. To observe the effectiveness and safety of the two treatment schemes for patients.
Study drug administration method:
Telitacicept was injected subcutaneously, 160mg/time, once a week, for 24 weeks.
Belimumab, 10mg/kg, was administered intravenously on the 0, 14 and 28 days, and then once every 28 days until the 24th week During the administration period of this study, the clinician fully evaluated the safety tolerance of patients using this product and decided whether to reduce the dose. The reason for adjusting the treatment plan needs to be recorded.
Reference of routine treatment plan:
High dose hormone plus cyclophosphamide was used for induction therapy, and then azathioprine or mycophenolate mofetil was used for maintenance therapy; Or high-dose hormone plus mycophenolate mofetil is used for induction therapy, and then mycophenolate mofetil is used for maintenance therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belimumab group | – | Drug: Belimumab |
| Telitacicept group | – | Drug: Telitacicept |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lupus nephritis
Key inclusion criteria (1 listed)
- 1. Age 18 to 65 years old, gender is not limited; 2. SLE patients with a clear diagnosis, that is, in line with the SLE classification criteria revised by the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019; 3. Patients with type III and type IV (with or without type V) lupus nephritis or simple type V lupus nephritis confirmed by biopsy within 6 months of the 2003 ISN/RPS criteria; only those with biopsy specimens showing activity were recruited Patients with lesions or active and chronic lesions; 4. ANA titer ≥ 1:80 and/or anti-dsDNA antibody positive; 5. Urine protein-to-creatinine ratio (UPCR) ≥ 1.0 mg/mg (and/or equivalent 24h urine protein level); 6. The urine protein decreased by less than 25% after receiving conventional treatment for at least 3 months before enrollment; 7. Voluntarily participate in this research and sign the informed consent.
Key exclusion criteria (1 listed)
- 1. eGFR<30 mL/min/1.73m2; 2. Patients requiring dialysis or kidney transplantation; 3. Patients who have received biological agents in the past; 4. Patients who have received mesenchymal stem cell therapy in the past; 5. Those who are known to be allergic to the study drug; 6. Women who are pregnant or planning to become pregnant in the near future, and women who are breastfeeding; 7. Patients with central nervous system lupus, thrombotic microangiopathy; 8. Patients who are currently suffering from active hepatitis or have a history of severe liver disease or disease; 9. Patients with immunodeficiency, uncontrolled severe infection and active or recurrent peptic ulcer; 10. Subjects who are participating in clinical research of other drugs; In addition to the above, the investigator judges that there are other reasons for not being suitable to participate in this clinical trial.
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 |
|---|---|---|
| BelimumabBelimumab, 10mg/kg, was administered intravenously on the 0, 14 and 28 days, and then once every 28 days until the 24th week | Drug | Belimumab group |
| TelitaciceptTelitacicept is injected subcutaneously, 160mg/time, once a week, for a total of 24 weeks | Drug | Telitacicept group |
Primary outcome
Proportion of patients achieving a primary renal efficacy response (PERR)
Time frame: 6 months
The main renal response response (PERR) was defined as: glomerular filtration rate (eGFR) ≥ 60ml/min/1.73m2 or eGFR decreased by no more than 20% from before recurrence; Urine protein: creatinine ratio (uPCR) ≤ 0.7; It is not a treatment failure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis and Belimumab, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Lingyun (13705186409, lingyunsun@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving a primary renal efficacy response (PERR) (time frame: 6 months). 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 20 Oct 2022.