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The objective of this study is to assess the efficacy and safety of rituximab combining with low-dose mycophenolate mofetil in the induction therapy of proliferative lupus nephritis in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab combining with low-dose mycophenolate mofetil | Experimental |
| |
| cyclophosphamide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Drug | Rituximab is given monthly (375m/m2;maximum 500mg) for 6 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | Patients are defined as having a complete response if they meet all the following conditions: ①Proteinuria is <0.5 g/1.73m^2 per day or protein-creatinine ratio from a morning spot urine <0.2 g/g ②Renal function is stabilized or improved(±10%-15% of baseline) | 6 months after the intervention |
| Partial response | A partial response is defined for patients who do not meet the complete response criteria but satisfy both of the following criteria: ①Urinary protein is reduced by ≥ 50% from baseline, and protein-creatinine ratio from a morning spot urine < 3.0g/g ②Renal function is stable or improved(±10%-15% of baseline). | 6 months after the intervention |
| No kidney response | No kidney response is defined as failure to achieve partial or complete response. | 6 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| SLEDAI scores | SLE disease activity is assessed by Systemic Lupus Erythematosus Disease Activity Index(SLEDAI)2000. | 6 months after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liangzhong Sun | Contact | +8613316202736 | sunlzh2018@smu.edu.cn |
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| Mycophenolate Mofetil (MMF) Treatment | Drug | The dose of mycophenolate mofetil is 10 to 15mg/kg/d for 6 months. |
|
| Cyclophosphamide | Drug | The therapy for cyclophosphamide is 750mg/m2(maximum 1000mg) every month for 6 doses. |
|
| ACEI / ARB | Drug | ACEI/ARB is recommended as the basic therapy for lupus nephritis. |
|
| Corticosteroid | Drug | Corticosteroid is recommended as the basic therapy for lupus nephritis. |
|
| Hydroxychloroquine (HCQ) | Drug | Hydroxychloroquine is recommended as the basic therapy for lupus nephritis. |
|
| 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 |
|---|---|
| D000069283 | Rituximab |
| D009173 | Mycophenolic Acid |
| D013812 | Therapeutics |
| D003520 | Cyclophosphamide |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D000305 | Adrenal Cortex Hormones |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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