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The goal of this single-center, prospective clinical trial is to test the safety and efficacy of belimumab combined with multi-target therapy in the treatment of severe lupus nephritis. The main questions it aims to answer are: lupus nephritis complete remission rate at week 24, and the partial remission rate and safety assessments. Patients with severe lupus nephritis will be enrolled and received pulse methylprednisolone at a dose of 1.5 to 3.0g, followed by intravenous belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks thereafter. Multitarget therapy will be also administered during the induction phase. Induction therapy will last for 24 weeks. Patients with severe lupus nephritis who only received multi-target therapy during the same period will be enrolled as the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab and multi-target therapy group | Other | Patients with severe lupus nephritis will be enrolled and received pulse methylprednisolone at a dose of 1.5 to 3.0g, followed by intravenous belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks thereafter. Multitarget therapy will be also administered during the induction phase. Induction therapy will last for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone Injectable Suspension | Drug | Methylprednisolone pulse therapy, total dose from 1500mg to 3000mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a cumulative complete response at week 24 of treatment. | Complete response will be defined as below:
| 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with partial response and non-response to treatment. | Partial response will be defined as a decrease of more than 50% of the baseline value of urinary protein and less than 3.5g/24h of urinary protein, a decrease of more than 50% of the baseline value of urinary sediment red blood cell count, and a normal or an increase of less than 30% of serum creatinine | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiong Zhang, PhD | Contact | 86-25-80862860 | jiongzhang@live.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhi-Hong Liu, MD | National Clinical Research Center of Kidney Diseases, Jinling Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiong Zhang | Recruiting | Nanjing | Jiangsu | 210016 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 9, 2026 | |
| Reset | Jan 26, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 9, 2026 | Jan 26, 2026 |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C511911 | belimumab |
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Belimumab Injection | Drug | Belimumab at a dose of 10mg per kilogram at weeks 2, 4, and 6, and every 4 weeks for 24 weeks. |
|
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| Immunosuppressive Agents | Drug |
|
|
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| Overall response rate at 24 weeks. | These will include complete remission and partial remission | 24 weeks |
| Improvement of clinical indicators. | Clinical improvement of the disease was assessed using systemic lupus erythematosus disease activity index. | 24 weeks |
| The changes of B cells. | The changes of CD20 number in peripheral blood will be observed and investigated. | 24 weeks |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |