A clinical trial comparing two-weekly versus four-weekly tapering of steroids in children with nephrotic syndrome
Phase 3
- Conditions
- Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality
- Registration Number
- CTRI/2021/10/037436
- Lead Sponsor
- Jawaharlal Nehru Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children with FRNS/SDNS on tapering prednisolone with or without levamisole
2.Age group 1-18 years
Exclusion Criteria
1.Secondary nephrotic syndrome or late steroid resistance.
2.Use of immunosuppressive medications other than oral prednisolone and levamisole in the preceding 6 months.
3.Impaired renal function (s.cr >1.2mg/dL) at enrollment.
4.Steroid threshold >1mg/kg on alternate days or features of steroid toxicity.
5.Patients unlikely to follow up at this centre.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with favorable outcome (sustained remission or infrequent relapses)Timepoint: At 1-year after enrollment
- Secondary Outcome Measures
Name Time Method 1.Time to first relapse <br/ ><br>2.Frequency of relapses at 6 and 12 months <br/ ><br>3.Cumulative prednisolone requirement <br/ ><br>4.Proportion with treatment failure <br/ ><br>5.Therapy associated adverse eventsTimepoint: During 1-year follow up peroid