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 (RITURNS II)
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|ClinicalTrials.gov Identifier: NCT03899103|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Steroid-Dependent Nephrotic Syndrome||Drug: Rituximab Drug: Mycophenolate Mofetil||Phase 3|
The vast majority of children with idiopathic nephrotic syndrome respond well to corticosteroid treatment. However, as many as 70% experience at least one relapse, and 30% develop a more complicated course with frequent relapses (FRNS) with or without steroid dependency (SDNS). Extended steroid exposure in these children often results in long-term complications. The management of patients with SDNS is challenging and expensive. Relapses may lead to serious complications, e.g. related to anasarca, hypertension, life threatening infections (peritonitis, pneumonia, meningitis), thrombosis and malnutrition. Repeated courses or even continuous steroid treatment lead to considerable medication related toxicity and morbidity.
The goal of treatment is to reduce the rate of relapses, the cumulative dose of corticosteroids, and the incidence of serious complications. Various prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population. Single rituximab infusion have been shown to be efficacious for 6 to 12 months and the side effect profile observed to date is very benign but after 6-8 months there was relapse due to regeneration of B-lymphocytes, hence for maintenance of remission MMF has been considered. In spite of good initial response, rituximab responders always remain prone to further relapse with regeneration of B lymphocytes, necessitating either repeat course of rituximab or addition of another steroid-sparing immunosuppressant. Reports suggest efficacy of rituximab may vary depending on disease pathology, clinical course, and simultaneous use of other immunosuppressants.
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial to Compare Efficacy and Safety of Repeated 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|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Repeated Courses of Rituximab Only
First 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.
First course Course Rituximab at Randomization.
Active Comparator: Rituximab and Mycophenolate Mofetil
First course Course Rituximab at Randomization. Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards.
First course Course Rituximab at Randomization.
Drug: Mycophenolate Mofetil
Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards
- 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 ]
- Cumulative prednisolone requirement (mg/kg/yr) over the first 12 and 24 months, respectively. [ Time Frame: 12 and 24 months ]
- Number and severity of adverse events [ Time Frame: 0-24 months ]
- Number of relapses within months 0-24, 0-12 and 12-24, respectively [ Time Frame: months 0-24, 0-12 and 12-24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899103
|Nilratan Sircar Medical College and Hospital||Recruiting|
|Kolkata, West Bengal, India, 700014|
|Contact: BISWANATH BASU, MD 9231236001 firstname.lastname@example.org|