Henoch Schonlein purpura nephritis
Conditions
Interventions
Experimental drug treatment group:Tacroximus capsule (trade name: Saifu X R), 0.1mg /kg/d, orally taken 1 hour before or 2-3 hours after meals twice a day for 24 weeks
Prednisone 1.5-2mg/kg/d was taken orally for 4 weeks and then changed to oral administration every other day for 4 weeks, gradually reducing the amount.
Control treatment group:Cyclophosphamide 8-10mg/ kg/d was given intravenously for 2 consecutive days, once every 2-4 weeks for 4 consecutive times, and once every 3 weeks for 2 consecutive times for 6
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 1 ~ <=18 years old; 2) Gender of the subject: No limitation; 3) For children newly diagnosed with HSPN (hospitalized), the classification and diagnosis criteria of HSPN are based on 2016 Evidence-based Guidelines for diagnosis and treatment of Purpura nephritis issued by the Nephrology Group of Pediatrics Branch of Chinese Medical Association, and the inclusion criteria shall be as follows: 4.Nephrotic level proteinuria, nephrotic syndrome, acute nephritis syndrome or pathological GRADE IIIb, IV; 4) Subjects and/or their guardians sign the informed consent; 5) The subject and/or his/her guardian are willing and able to cooperate with the completion of scheduled procedures such as modalities, treatment plans and laboratory tests.
Exclusion criteria
Exclusion criteria: 1) Hypertension, with mean systolic or diastolic blood pressure of 3 or more times higher than the 95th percentile of children of the same sex, age and height; 2) Diabetics or patients with abnormal fasting blood glucose (fasting blood glucose >= 6.1mmol/L twice); 3) eGFR < 60 ml/(min?1.73 m2); 4) Glaucoma or cataract; 5) Participate in clinical trials of other drugs within 1 month; 6) Other conditions in which the investigator considers it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage decrease of urinary protein at 24 h after 3 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage decrease of 24-hour urinary protein at 1 month and 6 months of treatment;Percentage change in eGFR at 1 month, 3 months, and 6 months of treatment;Percentage change in bp at 1 month, 3 months and 6 months after treatment;The percentage of hematuria disappeared at 1 month, 3 months and 6 months after treatment;The overall incidence of adverse events at 6 months of treatment; | — |
Countries
China
Contacts
Public ContactWu yubin
Shengjing Hospital of China Medical University
Outcome results
None listed