Multicenter Registry of Pediatric Lupus Nephritis in China

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

Interventions

DRUG

Corticosteroid

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

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.

DRUG

Mycophenolate Mofetil

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

DRUG

Azathioprine

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

DRUG

Tacrolimus

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

DRUG

Cyclosporine A

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

DRUG

Rituximab

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

Sponsors & Collaborators

• The Children's Hospital Affiliated to Suzhou University

  collaborator UNKNOWN

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Guizhou Provincial People's Hospital

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• The First Affiliated Hospital of Inner Mongolia Medical College

  collaborator UNKNOWN

• People's Hospital of Zhangjiajie

  collaborator UNKNOWN

• Puyang Oilfield General Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Guizhou Maternal and Child Health Care Hospital

  collaborator UNKNOWN

• The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University

  collaborator UNKNOWN

• Shenzhen Children's Hospital

  collaborator OTHER_GOV

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Xian Children's Hospital

  collaborator OTHER_GOV

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• The First Affiliated Hospital of Xinxiang Medical College

  collaborator OTHER

• Shanxi Provincial Maternity and Children's Hospital

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Fujian Provincial Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Children's Hospital of Hebei Province

  collaborator OTHER

• Beijing Children's Hospital

  collaborator OTHER

• Zhengzhou Children's Hospital

  collaborator UNKNOWN

• The Children's Hospital of Chongqing Medical University

  collaborator UNKNOWN

• Wuxi Women's & Children's Hospital

  collaborator OTHER

• The Children's Hospital of Fudan University

  collaborator UNKNOWN

• Shanghai Children's Medical Center

  collaborator OTHER

• Qilu Children's Hospital of Shandong University

  collaborator OTHER

• Xiqiang Dang

  lead OTHER

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-01

Primary Completion

2023-11-30

Completion

2024-11-30

FDA Drug

Yes

Countries

• China

Study Locations