Efficacy of Repeated courses of Rituximab vs. Rituximab and Mycophenolate Mofetil among Children Nephrotic Syndrome
- Conditions
- Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
- Registration Number
- CTRI/2019/04/018517
- 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
- 0
1.Children between 3 and 16 years with SDNS.
2.Minimal Change disease/ FSGS/MesPGN as per Kidney Biopsy report.
3.Estimated glomerular filtration rate(eGFR) >80 ml/min per 1.73 m2 at study entry.
4.Remission at study entry (Urine albumin nil or trace (or proteinuria <4 mg/m2/h) for 3 consecutive early morning specimens).
5.Not received any steroid sparing agent previously.
6.Parents willing to give informed written and audiovisual consent.
7.Ability to swallow tablet.
1.Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malig-nancy, other secondary forms of NS).
2.Patients with severe leukopenia (leukocytes <3.0Ã? 1000 cells/mm3), severe anemia (haemoglobin <8.9 g/dl), thrombocytopenia (platelet <100.0 Ã? 1000 cells/mm3) orderanged liver function tests (AST or ALT to >50 IU/L ) at enrolment.
3.Known active chronic infection (tuberculosis, HIV, hepatitis B or C).
4.Live vaccination within one month prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the time to first relapse or death (whichever occurs first) till end of study (follow-up phase of 24 months).Timepoint: The primary endpoint is the time to first relapse or death (whichever occurs first) till end of study (follow-up phase of 24 months).
- Secondary Outcome Measures
Name Time Method 1.Cumulative prednisolone requirement (mg/kg/yr) over the first 12 and 24 months, respectively. <br/ ><br>Timepoint: 12 and 24 months;Number and severity of adverse eventsTimepoint: 0-24 months;Number of relapses within months 0-24, 0-12 and 12-24, respectivelyTimepoint: months 0-24, 0-12 and 12-24