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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria in Children

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 Summary:

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.


Sponsor: Nanjing Children's Hospital

Current Primary Outcome: Disappearance of proteinuria [ Time Frame: 30 months ]

The proteinuria is < 150mg/d


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disappearance of hematuria [ Time Frame: 30 months ]
    The number of red blood cells is < 3 in each high power field of vision
  • Renal function [ Time Frame: 30 months ]
    The glomerular filtration rate is normal


Original Secondary Outcome: Same as current

Information By: Nanjing Children's Hospital

Dates:
Date Received: August 20, 2015
Date Started: August 2015
Date Completion: July 2018
Last Updated: October 29, 2016
Last Verified: October 2016