A study to assess the response to two different doses of prednisolone in children with relapse of nephrotic syndrome.
Not Applicable
- Conditions
- Health Condition 1: null- Nephrotic Syndrome
- Registration Number
- CTRI/2018/05/014075
- Lead Sponsor
- Chacha Nehru Bal Chikitsalaya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children aged 1-12 years of age with idiopathic steroid sensitive nephrotic syndrome presenting with relapse will be eligible for the study.
Exclusion Criteria
Children receiving or within 3â??months after receiving immunosuppressive medications like levamisole, cyclophosphamide, cyclosporine or rituximab
Children with concurrent infections
Children having associated co-morbidities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in the mean time to achieve remission between the group of children receiving 1mg/kg/day prednisolone and the group receiving 2mg/kg/day prednisolone during a relapse in children with steroid sensitive nephrotic syndrome.Timepoint: Up to maximum 2 weeks after randomization
- Secondary Outcome Measures
Name Time Method proportion of children with relapse of nephrotic syndrome, who achieved remission with 1mg/kg/day versus 2mg/kg/day of oral prednisolone.Timepoint: up to maximum of 4 weeks after randomization;The cumulative dose of steroids and adverse effects of glucocorticoids (hypertension, BMI, Serum calcium levels) between children in the treatment arms.Timepoint: In subsequent 12 months post randomization;The number of relapses over the subsequent 12 months following randomization into the treatment arms. <br/ ><br>Timepoint: over subsequent 12 months post randomization;To compare the time to first relapse following remission achieved after treatment of a relapse with 1mg/kg/day versus 2mg/kg/day of oral prednisolone.Timepoint: In due course over 12 months post randomization