Compare Efficacy and Safety of Repeated Courses of Rituximab to That of Maintenance Mycophenolate Mofetil Following Single Course of Rituximab Among Children With Steroid Dependent Nephrotic Syndrome
- Sponsor
- Nilratan Sircar Medical College
- Study ID
- NCT03899103
- Phase
- PHASE3
- Status
- Completed
Conditions
- Steroid-Dependent Nephrotic Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Years - 16 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGFirst course Course Rituximab at Randomization.
- Mycophenolate Mofetil — DRUGAddition of Maintenance Mycophenolate Mofetil from 4 Month onwards
Study Details
The aim of the RITURNS II study is to evaluate the efficacy and safety of Repeat courses of Rituximab to that of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 24 months among Children with Steroid Dependent Nephrotic Syndrome (SDNS).
Key Dates
- Start date
- May 15, 2019
- Status verified
- Dec 2024
- Primary completion
- Sep 5, 2023
- Completion
- Dec 24, 2023
Study Design
- Enrollment
- 100 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Repeated Courses of Rituximab OnlyFirst course Course Rituximab at Randomization. Prophylactic 2nd and 3rd course rituximab re-administration will be done at 8 months and 16 months of follow-up if B cell count normalize.
- Active Comparator: Rituximab and Mycophenolate MofetilFirst course Course Rituximab at Randomization. Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards.
Primary Outcome Measure
The primary endpoint is the time to first relapse or death (whichever occurs first) till end of study (follow-up phase of 24 months) [ Time Frame: 24 months ]