Clinical trial NCT04536181: Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome
Official title: Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome：a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Steroid-Sensitive Nephrotic Syndrome
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment
timeFrame: 12 month period after 3 month standard treatment
Secondary outcomes:
measure: Number of relapses during 12 months follow up after 3 month standard treatment
timeFrame: 12 month period after 3 month standard treatment
measure: Time to first relapse (days)
timeFrame: 12 month period after 3 month standard treatment
measure: Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment
timeFrame: 12 month period after 3 month standard treatment
measure: The use of steroid-sparing medications
timeFrame: 12 month period after 3 month standard treatment
measure: Adverse events during 12-month period after 3 month standard treatment
timeFrame: 12 month period after 3 month standard treatment
measure: Change in height during 12-month period after 3 month standard treatment
timeFrame: 12 month period after 3 month standard treatment
measure: Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment
timeFrame: 12 month period after 3 month standard treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Hospital
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Children's Hospital of Fudan University
name: Hong Xu, PhD.MD.
role: PRINCIPAL_INVESTIGATOR
References: