Multicenter Registry of Pediatric Lupus Nephritis in China

Recruiting

• Conditions: Lupus Nephritis; Children; Steroid; Immunosuppressive Treatment
• Interventions: Drug: Corticosteroid; Drug: Rituximab; Drug: Hydroxychloroquine; Drug: Mycophenolate Mofetil; Drug: Cyclophosphamide; Drug: Cyclosporine A; Drug: Azathioprine; Drug: Tacrolimus

• Registration Number: NCT03791827
• Lead Sponsor: Xiqiang Dang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2018-12-31
• Study First Posted: 2019-01-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05
• Primary Completion: 2023-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Corticosteroid and mycophenolate mofetil	Mycophenolate Mofetil	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
Corticosteroid and azathioprine	Corticosteroid	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
Corticosteroid	Corticosteroid	Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid
Corticosteroid	Hydroxychloroquine	Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid
Corticosteroid and cyclophosphamide	Cyclophosphamide	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
Corticosteroid and mycophenolate mofetil	Corticosteroid	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
Corticosteroid and mycophenolate mofetil	Hydroxychloroquine	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil
Corticosteroid and cyclophosphamide	Corticosteroid	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
Corticosteroid and cyclophosphamide	Hydroxychloroquine	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide
Corticosteroid and azathioprine	Hydroxychloroquine	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
Corticosteroid and tacrolimus	Corticosteroid	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus
Corticosteroid and tacrolimus	Hydroxychloroquine	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus
Corticosteroid and cyclosporine A	Corticosteroid	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
Corticosteroid and cyclosporine A	Hydroxychloroquine	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
Corticosteroid and cyclosporine A	Cyclosporine A	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A
Corticosteroid, mycophenolate mofetil and tacrolimus	Corticosteroid	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
Corticosteroid, mycophenolate mofetil and tacrolimus	Hydroxychloroquine	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
Corticosteroid, mycophenolate mofetil and tacrolimus	Azathioprine	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
Corticosteroid, mycophenolate mofetil and tacrolimus	Cyclosporine A	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus
Retuximab	Rituximab	An option for refractory lupus nephritis
Corticosteroid and azathioprine	Azathioprine	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine
Corticosteroid and tacrolimus	Tacrolimus	Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus

Primary Outcome Measures

Name	Time	Method
Complete remission	5 years	complete remission is defined as UPC\<0.2 mg/mg， or 24-hour urine protein\<150mg with normal kidney function and without hematuria
Partial remission	5 years	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China