The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria 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 with mild proteinuria 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 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.

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

Conditions
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Henoch-Schoenlein Purpura Nephritis

Intervention / Treatment
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* Drug: Prednisone
* Drug: ACEI


Participation Criteria
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Eligibility Criteria
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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

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: group 1<br>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. | Drug: Prednisone<br>* 1.5mg/kg/d<br>|
| Experimental: group 2<br>Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg) | Drug: ACEI<br>* 0.2-0.3mg/kg/d<br>* Other names: Lotensin;|

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 months | 

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 months | 
| Renal function | The glomerular filtration rate is normal | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild proteinuria