Study comparing two drugs Rituximab and Mycophenolate Mofetil in children with Steroid Resistant Nephrotic Syndrome whose disease is not controlled completely in spite of 2 years of drugs called Calcineurin Inhibitors - Cyclosporine and Tacrolimus
- Conditions
- Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
- Registration Number
- CTRI/2020/02/023281
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
(1) Age 5 - 18 years
(2) Idiopathic steroid resistant NS, initial or late resistance
(3) Minimal change disease or focal segmental glomerulosclerosis
(4) Therapy with either CNI (cyclosporine or tacrolimus) for two years or longer
(5) Complete or partial remission during therapy with calcineurin inhibitors
(6) Infrequent or frequent steroid sensitive relapses during therapy with calcineurin inhibitors
(1) Nephrotic syndrome secondary to systemic disease or infection
(2) Therapy with rituximab or mycophenolate mofetil in the last two years
(3) Inability to swallow tablets or capsules of mycophenolate mofetil
(4) Chronic infection with hepatitis B or C or human immunodeficiency virus
(5) Impaired renal function, as indicated by eGFR <60 mL/min per 1.73 m²
(6) Leukopenia, neutropenia, thrombocytopenia, elevated hepatic transaminases or hypogammaglobulinemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method