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This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN 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 marker 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 given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone & Cyclophosphamide | Experimental | Drug: prednisone & cyclophosphamide & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. |
|
| Prednisone & Mycophenolate mofetil | Experimental | Drug: prednisone & mycophenolate mofetil & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. |
|
| Prednisone & Leflunomide | Experimental | Drug: prednisone & leflunomide & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Disappearance of proteinuria | The proteinuria is < 150mg/d | 30 mo |
| Measure | Description | Time Frame |
|---|---|---|
| Disappearance of hematuria | The number of red blood cells is < 3 in each high power field of vision | 30 mo |
| 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 Aihua, 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 |
| D009173 | Mycophenolic Acid |
| D000077339 | Leflunomide |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| C044946 | benazepril |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Cyclophosphamide(CTX) |
| Drug |
|
| Mycophenolate mofetil(MMF) | Drug |
|
| Leflunomide(LEF) | Drug |
|
| Angiotensin-converting enzyme inhibitor(ACEI) | Drug |
|
|
| Methylprednisolone | Drug |
|
| 30 mo |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |