Prednisolone Trial in Children Younger Than 4 Years

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone

Criteria

Inclusion Criteria:

1. Idiopathic, steroid-sensitive, first episode of nephrotic syndrome

2. Age 12 months up to 48 months

3. Written informed consent

Exclusion Criteria

1. 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.

2. Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2,

3. Therapy with prednisolone for prior episodes of nephrotic syndrome,

4. Therapy with corticosteroids in the past 3 months, in a dose more than 1 mg/kg for >14 days for any other reason,

5. Corticosteroid therapy for initial episode of nephrotic syndrome prior to randomization varying from pre-specified protocol on more than 14 days,

6. Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome,

7. Unclear treatment history,

8. Gross hematuria,

9. Patients with initial steroid resistance,

10. Participation in any other drug study during the course of this study.

11. Participation in more than one study without approval from the researchers involved in each study,