Clinical trial NCT03791827: Multicenter Registry of Pediatric Lupus Nephritis in China
Official title: Multicenter Registry of Pediatric Lupus Nephritis in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lupus Nephritis
Children
Steroid
Immunosuppressive Treatment
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: The Children's Hospital Affiliated to Suzhou University
name: Shandong Provincial Hospital
name: Guizhou Provincial People's Hospital
name: LanZhou University
name: The First Affiliated Hospital of Inner Mongolia Medical College
name: People's Hospital of Zhangjiajie
name: Puyang Oilfield General Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Guizhou Maternal and Child Health Care Hospital
name: The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University
name: Shenzhen Children's Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Yichang Central People's Hospital
name: Xian Children's Hospital
name: Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science & Technology
name: The First People's Hospital of Yunnan
name: The First Affiliated Hospital of Xiamen University
name: The First Affiliated Hospital of Xinxiang Medical College
name: Shanxi Provincial Maternity and Children's Hospital
name: Liaocheng People's Hospital
name: Fujian Provincial Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Lanzhou University Second Hospital
name: Guangzhou First People's Hospital
name: The Second Hospital of Shandong University
name: Children's Hospital of Hebei Province
name: Beijing Children's Hospital
name: Zhengzhou Children's Hospital
name: The Children's Hospital of Chongqing Medical University
name: Wuxi Women's & Children's Hospital
name: The Children's Hospital of Fudan University
name: Shanghai Children's Medical Center
name: Qilu Children's Hospital of Shandong University
First posted: 2019-01-03
Enrollment: 1200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 1200 pediatric lupus nephritis patients younger than 18 years old will be enrolled from more than 35 pediatric nephrology medical centers nationwide

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.


Eligibility 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)

Primary outcomes:
measure: Complete remission
timeFrame: 5 years
measure: Partial remission
timeFrame: 5 years
Secondary outcomes:
measure: End stage renal disease (ESRD)
timeFrame: 1 year, 2 years, 3 years, 4 years and 5 years
measure: Mortality
timeFrame: 1 year, 2 years, 3 years, 4 years and 5 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References: