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

February 25, 2020 updated by: Aihua Zhang, Nanjing Children's Hospital

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

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

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aihua Zhang, M.D.
  • Phone Number: +8618951769017
  • Email: bszah@163.com

Study Contact Backup

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Children's Hospital
        • Contact:
          • Aihua Zhang, M.D.
          • Phone Number: +8618951769017
          • Email: bszah@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
1.5mg/kg/d
Experimental: group 2
Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)
0.2-0.3mg/kg/d
Other Names:
  • Lotensin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disappearance of proteinuria
Time Frame: 30 months
The proteinuria is < 150mg/d
30 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Aihua Zhang, M.D., Department of Nephrology, Nanjing children's hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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