Rituximab Versus Mycophenolate Mofetil in Children With Steriod-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 16
Healthy Volunteers: f
View:
• Children with a definite diagnosis of SDNS are included in the study during relapse treatment.
• Age 3-16 years.
• Steroid dependent dose≤0.3mg/kg/day.
• Cumulative steroid use for ≥6 months.
• Ability to swallow tablet.
• Guardians understand the characteristics and personal consequences of clinical trial.
• Guardians willing to give informed written consent.
Locations
Other Locations
China
Children's Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Yang Haiping, Doctor
oyhp@hospital.cqmu.edu.cn
8618983703661
Time Frame
Start Date: 2023-01-29
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 46
Treatments
Experimental: Rituximab
2 doses of rituximab 375 mg/m\^2 (Maximum 500mg/day)at 6 months intervals
Active_comparator: Mycophenolate Mofetil
MMF 20\~30mg/kg/day，BID
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Chongqing Medical University