Henoch-Schoenlein Purpura Nephritis
Conditions
Keywords
Mild proteinuria
Brief summary
This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN with mild proteinuria in children.
Detailed description
Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological markers for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children. The patients who are proved to get HSPN by renal biopsy will be randomized to receive either prednisone p.o. or angiotensin-converting enzyme inhibitor(ACEI) p.o. We will follow up them for about 2.5 years and compare the efficacy and safety of both measures by monitoring several indexes.
Interventions
DRUGPrednisone
1.5mg/kg/d
DRUGACEI
0.2-0.3mg/kg/d
Sponsors
Nanjing Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Renal biopsy proved HSPN (ISKDC class II) * Proteinuria \< 25 mg/kg/d
Exclusion criteria
* The children with congenital diseases * Proteinuria≥25 mg/kg/d
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disappearance of proteinuria | 30 months | The proteinuria is \< 150mg/d |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disappearance of hematuria | 30 months | The number of red blood cells is \< 3 in each high power field of vision |
| Renal function | 30 months | The glomerular filtration rate is normal |
Countries
China
Contacts
Primary ContactAihua Zhang, M.D.
Backup ContactYimei Wu
Outcome results
None listed