A study to compare effectiveness for preventing disease recurrence and safety regarding drug related side effects between a newer-safe drug(Rituximab) and conventionally used drug(Calcineurin Inhibitors)in children with difficult to treat nephrotic syndrome, a chronic protein loosing kidney disease.
- Conditions
- Health Condition 1: null- Nephrotic Syndrome
- Registration Number
- CTRI/2014/01/004355
- Lead Sponsor
- RS Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
Children between 3 and 16 years with SDNS
Minimal Change disease/ FSGS/MesPGN as per Kidney Biopsy report.
Estimated glomerular filtration rate(eGFR) more than 80 ml/min per 1.73 m2 at study entry.
Remission at study entry (trace or nil proteinuria, as determined by the dipstick test or less than 100 mg/dl for at least 3 days).
Not received any steroid sparing agent previously.
Parents willing to give informed written and audiovisual consent.
Ability to swallow tablet
Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS)
Patients with severe leucopenia (leucocytes less than 3.0Ã? 1000 cells/mm3), severe anemia (haemoglobin less than 8.9 g/dl), thrombocytopenia (platelet less than 100.0 Ã? 1000 cells/mm3) or deranged liver function tests (AST or ALT to more than 50 IU/L ) at enrolment.
Known active chronic infection (tuberculosis, HIV, hepatitis B or C)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method