The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children

Phase 2

• Conditions: Henoch-Schoenlein Purpura Nephritis
• Interventions: Drug: ACEI; Drug: Prednisone

• Registration Number: NCT02532790
• Lead Sponsor: Nanjing Children's Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Renal biopsy proved HSPN (ISKDC class II)
• Proteinuria < 25 mg/kg/d

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Exclusion Criteria

• The children with congenital diseases
• Proteinuria≥25 mg/kg/d

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	ACEI	Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)
group 1	Prednisone	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.

Primary Outcome Measures

Name	Time	Method
Disappearance of proteinuria	30 months	The proteinuria is \< 150mg/d

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nanjing Children's Hospital; 🇨🇳 Nanjing, Jiangsu, China