Health Condition 1: null- First episode of idiopathic steroid sensitive nephrotic syndrome
Conditions
Interventions
Intervention1: Prednisolone: 60 mg/m2 prednisolone orally daily, in two divided doses for 6 weeks, followed by 40 mg/m2 as a single dose on alternate days for 6 weeks, then at 30 mg/m2 for 4 weeks, 20
Sponsors
Arvind Bagga
Eligibility
Inclusion criteria
Inclusion criteria: Patients with idiopathic, steroid sensitive, first episode of nephrotic syndrome, 1 to 4 years old, shall be included.
Exclusion criteria
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion with relapse(s) during twelve monthsâ?? follow upTimepoint: During twelve months from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportions of the following cell subsets in peripheral blood: (a) B cells; (b) T cells: T cytotoxic cells; T helper (including Th1, Th2 and Th17) subsets, including naïve and memory and T regulatory cells; between the groups and within groups, at baseline with values at 6 and 12 months and at first relapseTimepoint: During twelve months from randomization;The cumulative prednisolone requirement (mg/kg/day)Timepoint: During twelve months from randomization;The growth and growth velocity as indicated by change in standard deviation scores (SDS) for weight, height and body mass indexTimepoint: During twelve months from randomization;The number of relapses Timepoint: During twelve months from randomization;The proportion of patients with frequent relapsesTimepoint: During twelve months from randomization;The time to first relapse (days)Timepoint: During twelve months from randomization;The time to frequent relapsesTimepoint: During twelve months from randomization;The use of steroid-sparing medications, e.g., levamisole, cyclophosphamide, mycophenolate mofetil and calcineurin inhibitorsTimepoint: During twelve months from randomization;Types and rates of adverse effects associated with corticosteroid therapyTimepoint: During twelve months from randomization | — |
Countries
India
Contacts
Public ContactArvind Bagga
All India Institute of Medical Sciences
Outcome results
None listed