Multicenter Registry of Pediatric Lupus Nephritis in China

NCT03791827 | Unknown FDA Drug

• 1 other identifier: Pediatric lupus nephritis
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Nephritis; Children; Steroid; Immunosuppressive Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• End stage renal disease (ESRD)

  1 year, 2 years, 3 years, 4 years and 5 years

• Mortality

  1 year, 2 years, 3 years, 4 years and 5 years

Study Arms (8)

Corticosteroid

Pediatric lupus nephritis treated with hydroxychloroquine and corticosteroid

Drug: Corticosteroid; Drug: Hydroxychloroquine

Corticosteroid and cyclophosphamide

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclophosphamide

Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Cyclophosphamide

Corticosteroid and mycophenolate mofetil

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and mycophenolate mofetil

Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Mycophenolate Mofetil

Corticosteroid and azathioprine

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and azathioprine

Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Azathioprine

Corticosteroid and tacrolimus

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and tacrolimus

Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Tacrolimus

Corticosteroid and cyclosporine A

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid and cyclosporine A

Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Cyclosporine A

Corticosteroid, mycophenolate mofetil and tacrolimus

Pediatric lupus nephritis treated with hydroxychloroquine, corticosteroid, mycophenolate mofetil and tacrolimus

Drug: Corticosteroid; Drug: Hydroxychloroquine; Drug: Azathioprine; Drug: Cyclosporine A

Retuximab

An option for refractory lupus nephritis

Drug: Rituximab

Interventions

Corticosteroid DRUG

corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.

Also known as: Steroid, Prednisone, Methylprednisone, Prednisolone

Corticosteroid; Corticosteroid and azathioprine; Corticosteroid and cyclophosphamide; Corticosteroid and cyclosporine A; Corticosteroid and mycophenolate mofetil; Corticosteroid and tacrolimus; Corticosteroid, mycophenolate mofetil and tacrolimus

Hydroxychloroquine DRUG

Hydroxychloroquine is recommended as the basic therapy for lupus nephritis

Corticosteroid; Corticosteroid and azathioprine; Corticosteroid and cyclophosphamide; Corticosteroid and cyclosporine A; Corticosteroid and mycophenolate mofetil; Corticosteroid and tacrolimus; Corticosteroid, mycophenolate mofetil and tacrolimus

Cyclophosphamide DRUG

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 cyclophosphamide

Mycophenolate Mofetil DRUG

The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d

Corticosteroid and mycophenolate mofetil

Azathioprine DRUG

The recommended dose of azathioprine is 1.5 to 2mg/kg/d

Corticosteroid and azathioprine; Corticosteroid, mycophenolate mofetil and tacrolimus

Tacrolimus DRUG

The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h

Corticosteroid and tacrolimus

Cyclosporine A DRUG

The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h

Corticosteroid and cyclosporine A; Corticosteroid, mycophenolate mofetil and tacrolimus

Rituximab DRUG

The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses

Also known as: anti-CD20 antibody

Retuximab

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Adrenal Cortex Hormones; Steroids; Prednisone; Prednisolone; Hydroxychloroquine; Cyclophosphamide; Mycophenolic Acid; Azathioprine; Tacrolimus; Cyclosporine; Rituximab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Pregnadienetriols; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Macrolides; Lactones; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Central Study Contacts

Xiqiang Dang, M.D.

CONTACT

8613739052618; dangxiqiang@csu.edu.cn

Tian Shen, M.D

CONTACT

8613548764640; shentian0215@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: January 3, 2019
• Study Start: December 1, 2018
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2024
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)