Status:
UNKNOWN
Multicenter Registry of Pediatric Lupus Nephritis in China
Lead Sponsor:
Xiqiang Dang
Collaborating Sponsors:
The Children's Hospital Affiliated to Suzhou University
Shandong Provincial Hospital
Conditions:
Lupus Nephritis
Children
Eligibility:
All Genders
Up to 18 years
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 registrati...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03791827
Start Date
December 1 2018
End Date
November 30 2024
Last Update
April 5 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011