Children with Henoch-Sch?nlein Purpura Nephritis
Conditions
Interventions
mizoribine:5 mg/kg body weight daily (maximum total dose: 150 mg)
Sponsors
Nanjing General Hospital of Nanjing Military Command
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. HSPN patients with moderate proteinuria (grade IIb and IIIa)(2550mg/kg/d/24 h proteinuria); 2. HSPN patients with nephrotic syndrome (grade?b and ?) (>50mg/kg/d/24 h proteinuria); 3. Male or female patient between 5 and 18 years age; 4. Patient who have participated any drug study within 3 months prior to screening; 5. Patients who sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. HSPN patients with grade IV or V disease; 2. Patient with IgA nephritis, thrombocytopenia purpura and systemic lupus erythematosus; 3. Patient with Ccr > 30 umol/L; 4. Patient who had history of allergy to MZR; 5. Patient with white blood cell count 420 mol/L, and if patient who have received the treatment of allopurinol (daily 8mg/kg, 2-3 times a day) for 2 weeks, patient who can not be reduced to < 420 mmol/L; 8. Patient who had received immunosuppressant (Cyclophosphamide, Tripterygium wilfordii (Chinese traditional medicine), Mycophenolate mofetil, Azathioprine and Tacrolimus, etc.) with immunosuppressive effect within 2 weeks prior to screening; 9. Patient who is unsuitable for participating in this study in the opinion of investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Remission Rate = Complete remission rate+Partial remission rate;Total Remission Rate;Partial remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| reducing effect of proteinuria;reducing effect of steroid;Assessment of the changes and percentage change of Serum albumin, serum creatinine, eGFR, Cholesterol, triglyceride, hematuria, ß-N-acetylglucosaminidase, C reactive protein and uric acid from the baseline; | — |
Countries
China
Contacts
Public ContactZhengkun Xia
Nanjing General Hospital of Nanjing Military Command
Outcome results
None listed