Prednisolone Trial in Children Younger Than 4 Years
Status:
Active, not recruiting
Trial end date:
2021-10-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi
Collaborators:
Department of Biotechnology, Government of India (funding agency) NephCure Accelerating Cures Institute University of Michigan