A study to examine whether treatment with prednisolone, given for 6 months for the first episode of nephrotic syndrome in children younger than 4 years isn more successful in keeping disease in control over one year than is therapy for 3 months
- Conditions
- Health Condition 1: null- First episode of idiopathic steroid sensitive nephrotic syndrome
- Registration Number
- CTRI/2015/06/005939
- Lead Sponsor
- Arvind Bagga
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 156
Patients with idiopathic, steroid sensitive, first episode of nephrotic syndrome, 1 to 4 years old, shall be included.
•Nephrotic syndrome known to be secondary to a systemic disorder, e.g., IgA nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, amyloidosis, hepatitis B antigenemia and Alport syndrome.
•Patients with impaired renal functions (serum creatinine >1.2 mg/dl, confirmed in 2 weeks)
•Patients who have received oral prednisolone, in the past for nephrotic syndrome
•Patients who have taken prednisolone in the past 4 weeks, in a dose more than 1 mg/kg for >10 days for any other reason
•Unclear treatment history
•Patients staying more than 100 km from the Institute or those not willing to come for clinic visits every two months
•Gross hematuria
•Patients with initial steroid resistance
•Patients who show relapse during the first 3 months of therapy (standard therapy)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion with relapse(s) during twelve monthsâ?? follow upTimepoint: During twelve months from randomization
- Secondary Outcome Measures
Name Time Method