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 losing kidney disease.
- Conditions
- Health Condition 1: null- Nephrotic Syndrome
- Registration Number
- CTRI/2015/01/005364
- Lead Sponsor
- RS Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
•Children between 3 and 16 years with SRNS
•Minimal Change disease/MesPGN/FSGS as per Kidney Biopsy report.
•Estimated glomerular filtration rate (eGFR) >80 ml/min per 1.73 m2 at study entry.
•Not received any steroid sparing agent previously.
•Parents willing to give informed written 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 <3.0Ã? 1000 cells/mm3), severe anemia (haemoglobin <8.9 g/dl), thrombocytopenia (platelet <100.0 Ã? 1000 cells/mm3) or deranged liver function tests (AST or ALT to >50 IU/L ) at enrolment.
•Known active chronic infection (tuberculosis, HIV, hepatitis B or C)
•Live vaccination within 1 mo.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12-month relapse-free survival in the intention-to-treat population.Timepoint: 3,6,9 and 12 month
- Secondary Outcome Measures
Name Time Method â?¢Frequency of relapses <br/ ><br>â?¢Time to first relapse <br/ ><br>â?¢Number of children achieved partial remission during study period <br/ ><br>â?¢Number of children with treatment failure <br/ ><br>â?¢Cumulative prednisolone dosage (mg/kg/year). <br/ ><br>â?¢Drug related side effects. <br/ ><br>Timepoint: number of relapses at 3,6,9 and 12 month