Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome

Last updated: December 14, 2020
Sponsor: Children's Hospital of Fudan University
Overall Status: Trial Not Available

Phase

3

Condition

Nephropathy

Kidney Failure (Pediatric)

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT04536181
CSICS
  • Ages 1-6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
  • Age 12 months up to 6 years
  • Written informed consent

Exclusion

Exclusion Criteria:

  • Nephrotic syndrome known to be secondary to a systemic disorder, e.g., ImmunoglobulinA (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-randomizationcorticosteroid therapy for nephrotic syndrome
  • Patients with initial steroid resistance
  • Patients who are allergic to glucocorticoids
  • The compliance of patients or their guardians is poor

Study Design

Study Start date:
January 01, 2021
Estimated Completion Date:
October 01, 2022

Connect with a study center

  • Children's hospital of Fudan university

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Shanghai Children's Hospital

    Shanghai,
    China

    Site Not Available

  • Shanghai Children's Medical Center

    Shanghai,
    China

    Site Not Available

  • Xinhua Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai,
    China

    Site Not Available

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