Multicenter Registry of Pediatric Lupus Nephritis in China

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.

Study Overview

• Status: Recruiting
• Conditions: Children; Lupus Nephritis; Steroid; Immunosuppressive Treatment
• Intervention / Treatment: Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Cyclophosphamide; Drug: Mycophenolate Mofetil; Drug: Azathioprine; Drug: Tacrolimus; Drug: Cyclosporine A; Drug: Rituximab

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Xiqiang Dang, M.D.; Phone Number: 8613739052618; Email: dangxiqiang@csu.edu.cn
• Study Contact Backup: Name: Tian Shen, M.D; Phone Number: 8613548764640; Email: shentian0215@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The Second Xiangya Hospital, Central South University
      • Contact: Tian Shen, M.D.; Phone Number: +8613548764640; Email: shentian0215@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Corticosteroid; Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid	Drug: Corticosteroid; corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Drug: Hydroxychloroquine; Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
Corticosteroid and cyclophosphamide; Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide	Drug: Corticosteroid; corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Drug: Hydroxychloroquine; Hydroxychloroquine is recommended as the basic therapy for lupus nephritis; Drug: 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.
Corticosteroid and mycophenolate mofetil; Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil	Drug: Corticosteroid; corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Drug: Hydroxychloroquine; Hydroxychloroquine is recommended as the basic therapy for lupus nephritis; Drug: Mycophenolate Mofetil; The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d
Corticosteroid and azathioprine; Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine	Drug: Corticosteroid; corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Drug: Hydroxychloroquine; Hydroxychloroquine is recommended as the basic therapy for lupus nephritis; Drug: Azathioprine; The recommended dose of azathioprine is 1.5 to 2mg/kg/d
Corticosteroid and tacrolimus; Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus	Drug: Corticosteroid; corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Drug: Hydroxychloroquine; Hydroxychloroquine is recommended as the basic therapy for lupus nephritis; Drug: Tacrolimus; The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h
Corticosteroid and cyclosporine A; Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A	Drug: Corticosteroid; corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Drug: Hydroxychloroquine; Hydroxychloroquine is recommended as the basic therapy for lupus nephritis; Drug: Cyclosporine A; The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
Corticosteroid, mycophenolate mofetil and tacrolimus; Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus	Drug: Corticosteroid; corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.; Other Names: Prednisolone; Prednisone; Steroid; Methylprednisone; Drug: Hydroxychloroquine; Hydroxychloroquine is recommended as the basic therapy for lupus nephritis; Drug: Azathioprine; The recommended dose of azathioprine is 1.5 to 2mg/kg/d; Drug: Cyclosporine A; The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
Retuximab; An option for refractory lupus nephritis	Drug: Rituximab; The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses; Other Names: anti-CD20 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mortality	Death of patients	1 year, 2 years, 3 years, 4 years and 5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: December 24, 2018
• First Submitted That Met QC Criteria: December 31, 2018
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Immunological; Dermatologic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Antitubercular Agents; Antimalarials; Antibiotics, Antitubercular; Calcineurin Inhibitors; Prednisolone; Cyclophosphamide; Rituximab; Prednisone; Azathioprine; Tacrolimus; Mycophenolic Acid; Cyclosporine; Cyclosporins; Hydroxychloroquine
• Other Study ID Numbers: Pediatric lupus nephritis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently, IPD is not available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No