Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
Conditions
Interventions
Intervention1: Injection rituximab: Single dose rituximab infusion of 375 mg/m2
Control Intervention1: Injection rituximab: 2 doses of rituximab infusion 375 mg/m2/dose 7 days apart
Sponsors
Institute of Child Health Kolkata AND Medical College Kolkata
Dr Subol Pradhan
Dr Sumantra Kumar Raut
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 10.Regular follow-up not feasible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To compare in the two groups the change in median height, weight and BMI SD scoreTimepoint: over 1 year follow up;To compare in the two groups the cumulative mycophenolate dosesTimepoint: over 1 year follow up;To compare in the two groups the cumulative prednisolone requirementTimepoint: over 1 year follow up;To compare in the two groups the frequency of antibiotics and antiviral used more than 3 daysTimepoint: over 1 year follow up;To compare in the two groups the frequency of hospitalizationTimepoint: over 1 year follow up;To compare in the two groups the frequency of relapsesTimepoint: over 1 year follow up;To compare in the two groups the median time to CD19 repopulationTimepoint: monitored over 1 year;To compare in the two groups the proportion of patients achieving depletion of B cells as assessed by CD19 count 1 week after the last dose of rituximabTimepoint: 1 week after the last dose of rituximab hrought out a year of patients recruitment;To compare in the two groups the proportion of patients developing low immunoglobulin post rituximab infusionTimepoint: at 6 and 12 months post infusion;To compare in the two groups the proportion of patients experiencing therapy associated adverse events including obesity, cushingoid habitus, cataract, glaucoma,leucopenia, thrombocytopenia, infusion related reactions (fever, chills, rash, bronchospasm, anaphylaxis), acute lung injury (related to rituximab), elevated liver enzymesTimepoint: over 1 year follow up;To compare in the two groups the proportion of patients free of corticosteroidsTimepoint: over 1 year follow up;To compare in the two groups the proportion of patients in sustained remissionTimepoint: over 1 year follow up;To compare in the two groups the proportion of patients showing frequent relapsesTimepoint: over 1 year follow up | — |
Countries
India
Contacts
Public ContactDr Rajiv Sinha
Institute Of Child Health, Kolkata
Outcome results
None listed