Clinical Trial: The Research of Standard Diagnosis and Treatment for HSPN 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 in Children
Brief Summary: This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN 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 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.
Sponsor: Nanjing Children's Hospital
Current Primary Outcome: Disappearance of proteinuria [ Time Frame: 30 mo ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Disappearance of hematuria [ Time Frame: 30 mo ]The number of red blood cells is < 3 in each high power field of vision
- Renal function [ Time Frame: 30 mo ]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