Steroid-Sensitive Nephrotic Syndrome
Conditions
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.
Interventions
DRUGPrednisolone
12 weeks prednisolone treatment
DRUGPlacebo
12 weeks simulated tablets
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment | 12 month period after 3 month standard treatment | Proportion of patients with frequent relapses at 12th month after 3 month standard treatment.Frequent relapses nephrotic syndrome was defined as two or more relapses within 6 months after completing initial treatment, or four relapses within any period of 12 months, including relapses during initial treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first relapse (days) | 12 month period after 3 month standard treatment | Number of days from randomization to occurrence of first relapse |
| Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment | 12 month period after 3 month standard treatment | Total amount of prednisolone \[or corticosteroid equivalent\] received, as mg/kg/day or mg/m2/day as intervention and for treatment of relapses, during 12 months follow up after 3 month standard treatment |
| The use of steroid-sparing medications | 12 month period after 3 month standard treatment | The proportion of patients in each study arm treated with steroid-sparing strategies or medications.it is a binary varibale (1/0). The variable wolud be sette into 1, if the patients use the steroid-sparing medications such as cyclophosphamide, levamisole, mycophenolate mofetil，rituximab and so on. |
| Number of relapses during 12 months follow up after 3 month standard treatment | 12 month period after 3 month standard treatment | Number of nephrotic syndrome relapses per patient year during the 12-month period after 3 month standard treatment |
| Change in height during 12-month period after 3 month standard treatment | 12 month period after 3 month standard treatment | The standard deviation scores (SDS) for height will be measured at 12th month and randomization. Change in height is SDS at 12 month minus that of randomization. |
| Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment | 12 month period after 3 month standard treatment | Proportion of patients with steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment.Steroid-dependent nephrotic syndrome was defined as steroid-sensitive nephrotic syndrome with 2 or more consecutive relapses during tapering or within 14 days of stopping steroids. |
| Adverse events during 12-month period after 3 month standard treatment | 12 month period after 3 month standard treatment | Number of adverse events experienced, related or unrelated to corticosteroid use |
Countries
China
Outcome results
None listed