Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
- Sponsor
- Children's Hospital of Fudan University
- Study ID
- NCT04783675
- Phase
- PHASE2
- Status
- Completed
Conditions
- Steroid-Sensitive Nephrotic Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGRituximab (375 mg/m2) will be given as a single intravenous infusion after remission
Study Details
The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in children with standard prednisolone treatment, once complete remission has occurred, that the use of Rituximab (a single intravenous infusion of 375 mg/m2) may reduce the risk of subsequent relapse during 12-month of follow-up.
Key Dates
- Start date
- Apr 13, 2021
- Status verified
- Jul 2023
- Primary completion
- Jan 17, 2023
- Completion
- Jan 17, 2023
Study Design
- Enrollment
- 44 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Intervention/treatment
Primary Outcome Measure
1-year relapse-free survival rate [ Time Frame: 1-year period after randomization ]