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This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN with mild proteinuria in children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | Prednisone Drug : prednisone 1.5mg/kg/d for 4-6 weeks, then 1.5mg/kg/d qod for 4 weeks, reduce 5mg every 2-4 weeks If the proteinuria decreases by less than 50% after treating for two months, this candidate reaches the ending point. |
|
| group 2 | Experimental | Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 1.5mg/kg/d |
| |
| ACEI |
| Measure | Description | Time Frame |
|---|---|---|
| Disappearance of proteinuria | The proteinuria is < 150mg/d | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disappearance of hematuria | The number of red blood cells is < 3 in each high power field of vision | 30 months |
| Renal function | The glomerular filtration rate is normal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aihua Zhang, M.D. | Contact | +8618951769017 | bszah@163.com | |
| Yimei Wu | Contact | +8615951757930 | wym891203@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Aihua Zhang, M.D. | Department of Nephrology, Nanjing children's hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Children's Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36853224 | Derived | Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4. |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C044946 | benazepril |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
0.2-0.3mg/kg/d |
|
|
| 30 months |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |