Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome
Status and phase
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Treatments
Details and patient eligibility
About
This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.
Sex
Ages
Volunteers
Inclusion criteria
- Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
- Age 12 months up to 6 years
- 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.
- Therapy with prednisolone for prior episodes of nephrotic syndrome
- Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2
- Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome
- Patients with initial steroid resistance
- Patients who are allergic to glucocorticoids
- The compliance of patients or their guardians is poor
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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