NCT03791827

Multicenter Registry of Pediatric Lupus Nephritis in China

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Xiqiang Dang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-12-01
• Primary completion: 2023-11-30
• Completion: 2024-11-30
• First posted: 2019-01-03
• Last updated: 2019-04-05

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study