Multicenter Registry of Pediatric Lupus Nephritis in China

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    1200
  • sponsor
    Xiqiang Dang
Updated on 22 January 2021

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.

Details
Condition Glomerulonephritis, Glomerulonephritis, Steroids, Child, SYSTEMIC LUPUS ERYTHEMATOSUS, SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis, Lupus Nephritis, Immunosuppressive Treatment, steroid compound
Treatment Rituximab, cyclophosphamide, mycophenolate mofetil, Tacrolimus, hydroxychloroquine, Azathioprine, Corticosteroid, Cyclosporine A
Clinical Study IdentifierNCT03791827
SponsorXiqiang Dang
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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