Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
Conditions
Interventions
Intervention1: Rituxumab: Dose: 375 mg/m² body surface area/ dose, IV infusion once a week for 2 weeks.
Repeat infusions at 6-month (or as clinically indicated based on relapse or proteinuria levels)
Sponsors
Dr Anannya Biswas
Eligibility
Inclusion criteria
Inclusion criteria: Patients with difficult to treat Steroid dependent nephrotic syndrome: Any 1 criteria met 1. Frequent relapses (Greater than or equal to 2 relapses in 6 months or greater than or equal to 3 relapses in 1 year) or steroid dependence 2. Failure of greater than or equal to 2 strategies ( alternate day prednisolone, levamisole, cyclophosphamide, MMF ) 3. Corticosteroid toxicity ( cataract , glaucoma ,short stature , low growth velocity , obesity )
Exclusion criteria
Exclusion criteria: 1. Active infection or history of recurrent severe infections. 2. Prior exposure to rituximab. 3. Severe cardiovascular or hepatic disease. 4. Uncontrolled comorbid conditions (e.g., diabetes, hypertension).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rateTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to remissionTimepoint: ;Relapse rateTimepoint: 12 months;Steroid sparing effectTimepoint: 12 months;Side effects and adverse eventsTimepoint: 12 months;Quality of lifeTimepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Anannya Biswas
IPGMER AND SSKM Hospital
Outcome results
None listed