Comparison of tapering of steroid treatment over 4 weeks versus 8 weeks in children with frequently relapsing nephrotic syndrome
- Conditions
- Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
- Registration Number
- CTRI/2024/07/070629
- Lead Sponsor
- Jawaharlal Institute of Post Graduate Medical Education and research JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Children 1-18 years of age with frequently relapsing or steroid dependent nephrotic syndrome on a steroid-sparing agent (levamisole/ mycophenolate mofetil/calcineurin inhibitor) for the preceding 2 months
Presenting with relapse
Children currently on/have received oral cyclophosphamide in the preceding 6 months
Children currently on/have received rituximab in the preceding 6 months
Children who do not achieve remission even after 6 weeks of prednisolone treatment for the current relapse (late steroid resistance)
Infantile onset nephrotic syndrome, monogenic and secondary forms of nephrotic syndrome (lupus nephritis, membranous nephropathy, etc.)
Patients with significant comorbidities like diabetes (type 1 or drug induced), glaucoma, avascular necrosis of hip, psychosis, etc.
Patient already enrolled in the study will not be re-enrolled in a future relapse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of relapses during the 6-months follow-up periodTimepoint: 6 months post randomization
- Secondary Outcome Measures
Name Time Method Incidence rate of relapses at 12-months post randomization <br/ ><br>Incidence rate of upper respiratory tract infection (URI)-triggered relapses at 6-months and 12-months post randomization <br/ ><br>Time to first relapse <br/ ><br>Time to treatment failure <br/ ><br>Sustained remission <br/ ><br>Cumulative steroid dose (in mg/kg) <br/ ><br>Steroid-related adverse events <br/ ><br>hsCRP levels (at enrolment and follow-up)Timepoint: monthly follow up for 12 months