Multicenter Registry of Pediatric Lupus Nephritis in China

Children Clinical Trial

Official title:

Multicenter Registry of Pediatric Lupus Nephritis in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791827
• Other study ID #: Pediatric lupus nephritis
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2019
• Source: Second Xiangya Hospital of Central South University
• Contact: Xiqiang Dang, M.D.
• Phone: 8613739052618
• Email: dangxiqiang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Children
• Immunosuppressive Treatment
• Lupus Nephritis
• Nephritis
• Steroid

Intervention

Drug:
• Corticosteroid
corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
• Hydroxychloroquine
Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
• Cyclophosphamide
The typical therapy for cyclophosphamide is either 500 to 750mg/m2 once every month for 6 doses or 8 to 12 mg/kg/d for two consecutive days every two weeks for 6 to 8 doses through i.v.
• Mycophenolate Mofetil
The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d
• Azathioprine
The recommended dose of azathioprine is 1.5 to 2mg/kg/d
• Tacrolimus
The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h
• Cyclosporine A
The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
• Rituximab
The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses

Locations

Country	Name	City	State
China	The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (34)

Lead Sponsor

Collaborator

Xiqiang Dang

Beijing Children's Hospital, Children's Hospital of Hebei Province, First Affiliated Hospital of Guangxi Medical University, Fujian Provincial Hospital, Guangzhou First People's Hospital, Guizhou Maternal and Child Health Care Hospital, Guizhou Provincial People's Hospital, LanZhou University, Liaocheng City People's Hospital, People's Hospital of Zhangjiajie, Puyang Oil Field General Hospital, Qilu Children's Hospital of Shandong University, Second Hospital of Lanzhou University, Shandong Provincial Hospital, Shanghai Children's Medical Center, Shanxi Provincial Maternity and Children's Hospital, Shenzhen Children's Hospital, The Children's Hospital Affiliated to Suzhou University, The Children's Hospital of Chongqing Medical University, The Children's Hospital of Fudan University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Inner Mongolia Medical College, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Xinxiang Medical College, The First People's Hospital of Yunnan, The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, The Second Affiliated Hospital of Harbin Medical University, The Second Hospital of Shandong University, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuxi Children's Hospital, Xian Children's Hospital, Yichang Central People's Hospital, Zhengzhou Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission	complete remission is defined as UPC<0.2 mg/mg, or 24-hour urine protein<150mg with normal kidney function and without hematuria	5 years
Primary	Partial remission	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	5 years
Secondary	End stage renal disease (ESRD)	ESRD is defined as eGFR<15ml/1.73m2, initiation of long-term dialysis or kidney	1 year, 2 years, 3 years, 4 years and 5 years
Secondary	Mortality	Death of patients	1 year, 2 years, 3 years, 4 years and 5 years