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

Nanjing Children's Hospital

Status and phase: Unknown; Phase 2

Conditions: Henoch-Schoenlein Purpura Nephritis

Treatments: Drug: Prednisone; Drug: ACEI

Study type: Interventional

Funder types: Other

Identifiers

NCT02532790

AiZhang

Details and patient eligibility

About

This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN with mild proteinuria in children.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

group 1

Experimental group

Description:

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.

Treatment:

Drug: Prednisone

group 2

Experimental group

Description:

Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)

Treatment:

Drug: ACEI