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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab group |
| ||
| Telitacicept group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab | Drug | Belimumab, 10mg/kg, was administered intravenously on the 0, 14 and 28 days, and then once every 28 days until the 24th week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with lupus nephritis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun Lingyun | Contact | 13705186409 | lingyunsun@nju.edu.cn |
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| Telitacicept | Drug | Telitacicept is injected subcutaneously, 160mg/time, once a week, for a total of 24 weeks |
|
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| 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 |
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| ID | Term |
|---|---|
| C511911 | belimumab |
| C000722462 | telitacicept |
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