The Research of Standard Diagnosis and Treatment for HSPN in Children

Last updated: February 25, 2020
Sponsor: Nanjing Children's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Nephritis

Treatment

N/A

Clinical Study ID

NCT02532777
AZhang
  • Ages 2-16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d

Exclusion

Exclusion Criteria:

  • The children with congenital diseases Proteinuria < 50 mg/kg/d

Study Design

Total Participants: 100
Study Start date:
August 01, 2015
Estimated Completion Date:
July 31, 2020

Study 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.

Connect with a study center

  • Nanjing Children's Hospital

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

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