Nephrotic Syndrome
Conditions
Interventions
3 months group:Placebo
6 months group:Prednisolone
Sponsors
Children's Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. Idiopathic, steroid-sensitive, first episode of nephrotic syndrome; 2. Aged 1 to 6 years; 3. Not treated by glucocorticoid and other immunosuppressive therapy; 4. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. 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; 2. Therapy with prednisolone for prior episodes of nephrotic syndrome; 3. Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2; 4. Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome; 5. Patients with initial steroid resistance; 6. Patients who are allergic to glucocorticoids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of relapses during 12 months follow up 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;The proportion of patients in each study arm treated with steroid-sparing strategies or medications.;Adverse events during 12-month period after 3 month standard treatment;Change in height during 12-month period after 3 month standard treatment;Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment; | — |
Countries
China
Contacts
Public ContactHong Xu
Children's Hospital of Fudan University
Outcome results
None listed