The Research of Standard Diagnosis and Treatment for HSPN in Children

Study Overview
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Brief Summary
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This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

Detailed Description
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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.

Official Title
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The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children

Conditions
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Henoch-Schoenlein Purpura Nephritis

Intervention / Treatment
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* Drug: Prednisone
* Drug: Cyclophosphamide(CTX)
* Drug: Mycophenolate mofetil(MMF)
* Drug: Leflunomide(LEF)
* Drug: Angiotensin-converting enzyme inhibitor(ACEI)
* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d Exclusion Criteria: The children with congenital diseases Proteinuria < 50 mg/kg/d

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisone & Cyclophosphamide<br>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. | Drug: Prednisone<br> <br> Drug: Cyclophosphamide(CTX)<br> <br> Drug: Angiotensin-converting enzyme inhibitor(ACEI)<br> <br> * Other names: Lotensin;Drug: Methylprednisolone<br> <br> |
| Experimental: Prednisone & Mycophenolate mofetil<br>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. | Drug: Prednisone<br> <br> Drug: Mycophenolate mofetil(MMF)<br> <br> Drug: Angiotensin-converting enzyme inhibitor(ACEI)<br> <br> * Other names: Lotensin;Drug: Methylprednisolone<br> <br> |
| Experimental: Prednisone & Leflunomide<br>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. | Drug: Prednisone<br> <br> Drug: Leflunomide(LEF)<br> <br> Drug: Angiotensin-converting enzyme inhibitor(ACEI)<br> <br> * Other names: Lotensin;Drug: Methylprednisolone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disappearance of proteinuria | The proteinuria is < 150mg/d | 30 mo | 

Secondary Outcome Measures

| Outcome Measure | 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 | 30 mo |