Health Condition 1: null- Nephrotic Syndrome
Conditions
Interventions
Intervention1: Low dose prednisolone on alternate days given daily during infections: Prednisolone given on alternate days at 0.5-0.7 mg/kg, given daily for 7 days during each infection
Control Interv
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: a) Patients with idiopathic steroid responsive nephrotic syndrome with frequent relapses or steroid dependence in the preceding 6 months b) Age at onset of frequent relapses or steroid dependence between 2 and 18 years c) Prednisolone requirement d) Parents willing to give informed written consent
Exclusion criteria
Exclusion criteria: a) Known etiology (e.g., systemic lupus erythematosus, IgA nephropathy, amyloidosis) b) Prior therapy with levamisole, cyclosporine, tacrolimus or azathioprine c) Therapy with oral or intravenous cyclophosphamide or intravenous rituximab in the preceding 6 months d) Thrombocytopenia, leukopenia or deranged liver function tests e) Known chronic infection (tuberculosis, HIV, hepatitis B or C) f) Known malignancy g) Severe malnutrition (WHO classification); body mass index >30 or height h) Presence of cataract or glaucoma i) Estimated glomerular filtration rate j) Residing more than 100 km away or unwilling to come for regular follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with frequent relapsesTimepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects associated with therapy (costicosteroids: Cushingoid habitus, obesity, hypertension, glaucoma, cataract; levamisole: leukopenia, thrombocytopenia, rash, seizures)Timepoint: 1 year;Cumulative prednisolone doseTimepoint: 1 year;Frequency and type of infectionsTimepoint: 1 year;Frequency of relapsesTimepoint: 1 year;Growth velocityTimepoint: 1 year;Proportion of patients wiht infection associated relapsesTimepoint: 1 year;Proportion of patients with sustained remissionTimepoint: 1 year;Time to first relapseTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactArvind Bagga
All India Institute of Medical Sciences
Outcome results
None listed