Steroid-sensitive primary nephrotic syndrome in children
Conditions
Interventions
Group A:Prednisolone (tablets) + Huai Qi Huang (particle)
Group B:Prednisolone (tablets) + placebo (particle)
Sponsors
Children's Hospital Affiliated to Fudan UniversityNanjing Children's Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. PNS patients; 2. New onset patients; 3. Age from 1-12 year-old; 4. Sensitive to initial steroid therapy: urine protein turns negative within 4 weeks of prednisolone (2mg/kg or 60mg/m2) treatment; 5. Exclude secondary nephrotic syndrome, such as systemic lupus erythematosus nephritis, anaphylactoid purpura nephritis, HBV, HCV, HIV-associated glomerulonephritis, drug-induced nephritis; 6. Agreed to participate in this study, and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Urinary protein positive after 4 weeks of initial steroid treatment; 2. Continuous treatment of steroid for more than 3 months in last one year; 3. Allergy history of prednisolone or Huai Qi Huang particles; 4. With cocurrent diseases such as diabetes, liver disease, active ulcer, arthritis, myopathy, cardiovascular diseases, blood diseases, mental illness, cancer, etc.; 5. Liver and renal function abnormalities; 6. Participate in other clinical trials meanwhile; 7. With poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse (times / person);Recurrence rate (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration from the end of initial steroid treatment;Blood pressure before and after intervention;Percentage of steroid resistant patient (%);Percentage of recurrence patient (%);Serum IgA, IgG, IgM level before and after interv;Serum IL-4, IL-12 level before and after intervention;Serum T cell subsets before and after intervention;Persons of hypertensive till the end of follow-up;Total amount of steroid till the end of follow-up;Times of infection till the end of follow-up (time); | — |
Countries
China
Contacts
Public ContactHong Xu
Outcome results
None listed