Study of Rituximab Monotherapy VS Steroid Therapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The main objective is to evaluate the effectiveness of Rituximab monotherapy versus steroid therapy on children with new-onset nephrotic syndrome within the 52-week follow-up.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• New-onset idiopathic nephrotic syndrome
• Glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.
Locations
Other Locations
China
Children's Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jianhua Mao, PHD.MD
maojh88@zju.edu.cn
86057186670015
Backup
Fei Liu
alexdevin@163.com
Time Frame
Start Date: 2023-02-09
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 80
Treatments
Experimental: Rituximab Group
Rituximab dose: 4 doses of 375 mg/m2 rituximab at 1-week intervals( within +7 days).
Active_comparator: Steroid Group
Daily oral prednisone/prednisolone 2 mg/kg/d (maximum 60 mg/d) for 6 weeks followed by alternate day prednisone/prednisolone, 1.5 mg/kg (maximum of 50 mg), for other 6 weeks.
Related Therapeutic Areas
Sponsors
Leads: The Children's Hospital of Zhejiang University School of Medicine