The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria in Children
Overview
- Phase
- Phase 2
- Intervention
- Prednisone
- Conditions
- Henoch-Schoenlein Purpura Nephritis
- Sponsor
- Nanjing Children's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Disappearance of proteinuria
- Last Updated
- 6 years ago
Overview
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.
Investigators
Aihua Zhang
Hospital vice president
Nanjing Children's Hospital
Eligibility Criteria
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
Arms & Interventions
group 1
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.
Intervention: Prednisone
group 2
Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)
Intervention: ACEI
Outcomes
Primary Outcomes
Disappearance of proteinuria
Time Frame: 30 months
The proteinuria is \< 150mg/d
Secondary Outcomes
- Disappearance of hematuria(30 months)
- Renal function(30 months)