Multicenter Registry of Pediatric Lupus Nephritis in China

Xiqiang Dang

Status: Enrolling

Conditions: Steroid; Immunosuppressive Treatment; Lupus Nephritis; Children

Treatments: Drug: Azathioprine; Drug: Cyclosporine A; Drug: Hydroxychloroquine; Drug: Cyclophosphamide; Drug: Tacrolimus; Drug: Corticosteroid; Drug: Mycophenolate Mofetil; Drug: Rituximab

Study type: Observational

Funder types: Other

Identifiers

NCT03791827

Pediatric lupus nephritis

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

1,200 participants in 8 patient groups

Corticosteroid

Description:

Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid

Treatment:

Drug: Corticosteroid

Drug: Hydroxychloroquine

Corticosteroid and cyclophosphamide

Description:

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide

Treatment:

Drug: Corticosteroid

Drug: Cyclophosphamide

Drug: Hydroxychloroquine

Corticosteroid and mycophenolate mofetil

Description:

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil

Treatment:

Drug: Mycophenolate Mofetil

Drug: Corticosteroid

Drug: Hydroxychloroquine

Corticosteroid and azathioprine

Description:

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine

Treatment:

Drug: Corticosteroid

Drug: Azathioprine

Drug: Hydroxychloroquine

Corticosteroid and tacrolimus

Description:

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus

Treatment:

Drug: Corticosteroid

Drug: Tacrolimus

Drug: Hydroxychloroquine

Corticosteroid and cyclosporine A

Description:

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A

Treatment:

Drug: Corticosteroid

Drug: Cyclosporine A

Drug: Hydroxychloroquine

Corticosteroid, mycophenolate mofetil and tacrolimus

Description:

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus

Treatment:

Drug: Corticosteroid

Drug: Azathioprine

Drug: Cyclosporine A

Drug: Hydroxychloroquine

Retuximab

Description:

An option for refractory lupus nephritis

Treatment:

Drug: Rituximab