WithdrawnPhase 3

Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

Stopped: lack of funding

China0Started 2021-01-01

Plain-language summary

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.

Who can participate

Age range1 Year – 6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment

Timeframe: 12 month period after 3 month standard treatment

Trial details

NCT IDNCT04536181

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01