Health Condition 1: null- Nephrotic syndrome
Conditions
Interventions
Intervention1: Daily loe dose Prednisolone: Daily low dose prednisolone(0.15-2mg/kg/day)administered orally for 12 months
Control Intervention1: Standard alternate day prednisolone therapy: Standard a
Sponsors
Council of Scientific and Industrial Research
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 2-16 years with frequently relapsing/steroid dependent nephrotic syndrome.
Exclusion criteria
Exclusion criteria: Steroid resistant nephrotic syndrome, congenital nephrotic syndrome Nephrotic syndrome secondary to systemic disease (systemic lupus erythematosus, IgA nephropathy, infection with HIV or hepatitis B or C. Intake of immunosuppressive medications other than oral prednisolone in the preceding 6 months One or more features of steroid toxicity, as defined by body mass index >95th percentile for age and gender, presence of cataract or stage 2 hypertension. Refusal of informed parental consent High steroid threshold to prevent relapses ( >1 mg/kg on alternate days) Recent ( Occurrence of more than two relapses during any 6-months, or 3 or more relapses in 12 months while receiving intervention, will be taken as trial deviate and require initiation of alternative therapy. Occurrence of late resistance to corticosteroids Subjects in whom the intervention cannot be given for one year, or is interrupted for more than two weeks period of time; e.g. subjects who become very sick and have to be withdrawn from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare, over 12 months, the frequency of relapses in patients with frequently relapsing nephrotic syndrome administered therapy with prednisolone daily in low doses versus its adminsitered on alternate days (standard therapy). Timepoint: To compare, at 12 months, the frequency of relapses in patients with frequently relapsing nephrotic syndrome administered therapy with prednisolone daily in low doses versus its adminsitered on alternate days (standard therapy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first relapse Proportion of patients with sustained remission or frequent relapses. Frequency and types of infections. Proportion of patients showing suppression of the hypothalmic- pituitary-adrenal axis, as determined by the ACTH stimulation test(Synacthen test), at the onset of study and 12 months follow up. Proportion of patients with corticosteroid related adverse events.Timepoint: 1years | — |
Countries
India
Contacts
Public ContactDr Arvind Bagga
All India Institute of Medical Sciences
Outcome results
None listed