Multicenter Registry of Pediatric Lupus Nephritis in China

Study Overview
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Brief Summary
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This study is designed to evaluate the efficacy and safety of the current treatment option and outcome of pediatric lupus nephritis patients in China. Investigators will perform prospective registration study among at least 35 pediatric nephrology medical centers in China.

Official Title
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Multicenter Registry of Pediatric Lupus Nephritis in China

Conditions
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Lupus Nephritis, Children, Steroid, Immunosuppressive Treatment

Intervention / Treatment
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* Drug: Corticosteroid
* Drug: Hydroxychloroquine
* Drug: Cyclophosphamide
* Drug: Mycophenolate Mofetil
* Drug: Azathioprine
* Drug: Tacrolimus
* Drug: Cyclosporine A
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of lupus nephritis: Diagnosis of SLE according to the 1997 update of the 1982 American College of Rheumatology revised criteria for classification of systemic lupus erythematosus Either of the following: Positive urine protein detected 3 times within a week, or 24-hour urine protein>150mg, or UPC>0.2mg/mg, or urinary microalbumin above normal range detected 3 times within a week, or microscopic examination erythrocyte>5 RBC/HP, or renal dysfunction including glomerular and/or tubular dyfunction, or abnormal renal biopsy and the pathological changes are in accordance with lupus nephritis The pathological diagnosis of kidney conforms to the International Society of Nephrology and Society of Renal Pathology (ISN/RPS) standards in 2003 Exclusion Criteria (either of the following criteria): Complicated with other systemic diseases, including basic diseases with clinical significance Patients with tumors Patients with abnormal glucose metabolism Immunodeficiency patients Patients diagnosed as tuberculosis, or hepatitis B, or hepatitis C within three months before treatment Patients with other connective tissue diseases (such as Sjogren's syndrome, mixed connective tissue disease, etc.) Drug-induced lupus, congenital lupus and other secondary lupus Renal histopathology with non-inflammatory necrotizing angiopathy or thrombotic microangiopathy (TMA)

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Corticosteroid<br>Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid | Drug: Corticosteroid<br>* corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.<br>* Other names: Prednisolone;Drug: Hydroxychloroquine<br>* Hydroxychloroquine is recommended as the basic therapy for lupus nephritis<br>|
| Corticosteroid and cyclophosphamide<br>Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide | Drug: Corticosteroid<br>* corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.<br>* Other names: Prednisolone;Drug: Hydroxychloroquine<br>* Hydroxychloroquine is recommended as the basic therapy for lupus nephritis<br>Drug: Cyclophosphamide<br>* The typical therapy for cyclophosphamide is either 500 to 750mg/m2 once every month for 6 doses or 8 to 12 mg/kg/d for two consecutive days every two weeks for 6 to 8 doses through i.v.<br>|
| Corticosteroid and mycophenolate mofetil<br>Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil | Drug: Corticosteroid<br>* corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.<br>* Other names: Prednisolone;Drug: Hydroxychloroquine<br>* Hydroxychloroquine is recommended as the basic therapy for lupus nephritis<br>Drug: Mycophenolate Mofetil<br>* The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d<br>|
| Corticosteroid and azathioprine<br>Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine | Drug: Corticosteroid<br>* corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.<br>* Other names: Prednisolone;Drug: Hydroxychloroquine<br>* Hydroxychloroquine is recommended as the basic therapy for lupus nephritis<br>Drug: Azathioprine<br>* The recommended dose of azathioprine is 1.5 to 2mg/kg/d<br>|
| Corticosteroid and tacrolimus<br>Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus | Drug: Corticosteroid<br>* corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.<br>* Other names: Prednisolone;Drug: Hydroxychloroquine<br>* Hydroxychloroquine is recommended as the basic therapy for lupus nephritis<br>Drug: Tacrolimus<br>* The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h<br>|
| Corticosteroid and cyclosporine A<br>Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A | Drug: Corticosteroid<br>* corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.<br>* Other names: Prednisolone;Drug: Hydroxychloroquine<br>* Hydroxychloroquine is recommended as the basic therapy for lupus nephritis<br>Drug: Cyclosporine A<br>* The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h<br>|
| Corticosteroid, mycophenolate mofetil and tacrolimus<br>Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus | Drug: Corticosteroid<br>* corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.<br>* Other names: Prednisolone;Drug: Hydroxychloroquine<br>* Hydroxychloroquine is recommended as the basic therapy for lupus nephritis<br>Drug: Azathioprine<br>* The recommended dose of azathioprine is 1.5 to 2mg/kg/d<br>Drug: Cyclosporine A<br>* The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h<br>|
| Retuximab<br>An option for refractory lupus nephritis | Drug: Rituximab<br>* The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses<br>* Other names: anti-CD20 antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission | complete remission is defined as UPC<0.2 mg/mg， or 24-hour urine protein<150mg with normal kidney function and without hematuria | 5 years | 
| Partial remission | Partial remission is defined as non-nephrotic range proteinura, decrease of urine protein ≥50%， and serum creatinine remains stable (±25% of baseline) or is improved but not normal yet | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End stage renal disease (ESRD) | ESRD is defined as eGFR<15ml/1.73m2, initiation of long-term dialysis or kidney | 1 year, 2 years, 3 years, 4 years and 5 years | 
| Mortality | Death of patients | 1 year, 2 years, 3 years, 4 years and 5 years |