The Research of Standard Diagnosis and Treatment for HSPN 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 in Children

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

Study Overview

Status

Unknown

Conditions

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 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.

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

Study Contact Backup

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

Study Locations

  • China
    • 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 Proteinuria ≥ 50 mg/kg/d

Exclusion Criteria:

  • The children with congenital diseases Proteinuria < 50 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: Prednisone & Cyclophosphamide

Drug: prednisone & cyclophosphamide & Angiotensin-converting enzyme inhibitor(ACEI).

Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.

cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
Drug: Prednisone
Drug: Methylprednisolone
Drug: Cyclophosphamide(CTX)
Drug: Angiotensin-converting enzyme inhibitor(ACEI)
Other Names:
  • Lotensin
Experimental: Prednisone & Mycophenolate mofetil

Drug: prednisone & mycophenolate mofetil & Angiotensin-converting enzyme inhibitor(ACEI).

Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.

mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
Drug: Prednisone
Drug: Methylprednisolone
Drug: Angiotensin-converting enzyme inhibitor(ACEI)
Other Names:
  • Lotensin
Drug: Mycophenolate mofetil(MMF)
Experimental: Prednisone & Leflunomide

Drug: prednisone & leflunomide & Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.

Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d.

Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy.
Drug: Prednisone
Drug: Methylprednisolone
Drug: Angiotensin-converting enzyme inhibitor(ACEI)
Other Names:
  • Lotensin
Drug: Leflunomide(LEF)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Nanjing Children's Hospital

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 23, 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

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZhang

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.

Clinical Trials on Henoch-Schoenlein Purpura Nephritis

Clinical Trials on Prednisone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe