A study to compare the effect and safety of one dose versus two doses of rituximab in children with relapsing nephrotic syndrome
- Conditions
- Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
- Registration Number
- CTRI/2020/09/028055
- Lead Sponsor
- Institute of Child Health Kolkata AND Medical College Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients with idiopathic nephrotic syndrome with steroid dependence or frequent relapses who has failed at least two steroid sparing agents, last one being failed in previous 3 months
2. Patients is in remission state of the disease
3. Legal guardian is willing to give informed written consent
1.Prior therapy with rituximab in last one year
2.Historical steroid resistance in last one year
3.Hepatitis B and C serology positive
4.Acute or chronic active infection
5.Chronic lung disease or uncontrolled asthma
6.Leucopenia or thrombocytopenia
7.Expected rituximab first infusion date less than 4 weeks from a live vaccination
8.Documented intolerance to mycophenolate in past
9.eGFR < 60 ml/min/1.73m2
10.Regular follow-up not feasible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the non inferiority of single dose rituximab 375 mg/m2 versus 2 doses of rituximab 375 mg/m2/dose a weeks apart in respect to increase in median time to first relapse in patients 2-12 years of age with steroid dependant or frequently relapsing nephrotic syndrome who has failed atleast two steroid sparing agents while being maintained on mycophenolateTimepoint: over a period of 1 year follow up
- Secondary Outcome Measures
Name Time Method