Health Condition 1: null- Initial episode of steroid sensitive nephrotic syndrome
Conditions
Interventions
Intervention1: prednisolone: 2 mg/kg/day for 6 weeks, then 1.5 mg/kg on alternate days for 6 weeks, then 1 mg/kg on alternate days for 4 weeks, then 0.75 mg/kg on alternate days for 4 weeks, and then
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with idiopathic, steroid sensitive nephrotic syndrome 2. First episode of nephrotic syndrome 3. Age 1 to 12 years
Exclusion criteria
Exclusion criteria: 1. 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. 2. Patients with impaired renal functions (serum creatinine > 1.2 mg/dl, confirmed within 2 weeks) 3. Patients who have received oral prednisolone, in the past for nephrotic syndrome 4. 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 5. Unclear treatment history. 6. Patients staying more than 100 km from the Institute or those not willing to come for clinic visits every two months 7. Gross hematuria 8. Patients with initial steroid resistance 9. Patients who show relapse within the first 3 months of therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of relapse during one year follow up, in patients receiving 6 months versus 3 months of prednisolone therapy for the initial episode of nephrotic syndromeTimepoint: one year after cessation of therapy with prednisolone | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The time to first relapse (days) after discontinuation of initial treatment 2) The proportion of patients with frequent relapses at 1 year, after discontinuation of initial therapy 3) The cumulative prednisolone requirement (mg/kg/day) at 1 year 4) The use of alternative medications, e.g., levamisole, cyclophosphamide, calcineurin inhibitors at 1 year 5) Side effects of corticosteroids (as defined in the protocol) at the end of initial therapy, 1 year Timepoint: One year after cessation of intervention | — |
Countries
India
Contacts
Public ContactArvind Bagga
Outcome results
None listed