Prednisolone Trial in Children Younger Than 4 Years (NCT03141970) | Clinical Trial Compass
CompletedPhase 3
Prednisolone Trial in Children Younger Than 4 Years
United States, India170 participantsStarted 2015-07-01
Plain-language summary
This study is a multicentric, randomized, parallel group, open label controlled trial of children age 1 year up to 4 years with new onset, idiopathic nephrotic syndrome. It is designed to test the initial duration of steroid therapy of either 3 month or 6 month total duration. Participants will be randomized to either extend their pre-trial 3 months (12 weeks) of standard of care corticosteroid therapy to add an additional 12 weeks of therapy or to stop therapy. Pre-trial standard of care corticosteroids will include 60 mg/m2/day for 6 weeks followed by 40 mg/m2/day every other day for 6 weeks of prednisolone or equivalent. The trial intervention will therefore be an additional 12 vs 0 weeks of corticosteroids in these children with idiopathic nephrotic syndrome.
Who can participate
Age range1 Year – 4 Years
SexALL
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Inclusion criteria
✓. Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
✓. Age 12 months up to 48 months
✓. Written informed consent
Exclusion criteria
✕. Nephrotic syndrome known to be secondary to a systemic disorder, e.g., Immunoglobulin A (IgA) nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, , hepatitis B or Alport syndrome.