NCT02532777

The Research of Standard Diagnosis and Treatment for HSPN in Children

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Nanjing Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Henoch-Schoenlein Purpura Nephritis

Interventions

Type	Name	Description
DRUG	Prednisone
DRUG	Cyclophosphamide(CTX)
DRUG	Mycophenolate mofetil(MMF)
DRUG	Leflunomide(LEF)
DRUG	Angiotensin-converting enzyme inhibitor(ACEI)
DRUG	Methylprednisolone

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2015-08-26
• Last updated: 2020-02-26

Locations

1 site across 1 country: China