Back to resultsThe Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children
Primary Purpose
Henoch-Schoenlein Purpura Nephritis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Prednisone
ACEI
Sponsored by
About this trial
This is an interventional treatment trial for Henoch-Schoenlein Purpura Nephritis focused on measuring Mild proteinuria
Eligibility Criteria
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
Sites / Locations
- Nanjing Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group 1
group 2
Arm Description
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.
Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)
Outcomes
Primary Outcome Measures
Disappearance of proteinuria
The proteinuria is < 150mg/d
Secondary Outcome Measures
Disappearance of hematuria
The number of red blood cells is < 3 in each high power field of vision
Renal function
The glomerular filtration rate is normal
Full Information
NCT ID
NCT02532790
First Posted
August 20, 2015
Last Updated
February 25, 2020
Sponsor
Nanjing Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02532790
Brief Title
The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children
Official Title
The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis With Mild Proteinuria in Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Henoch-Schoenlein Purpura Nephritis
Keywords
Mild proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
group 2
Arm Type
Experimental
Arm Description
Angiotension converting enzyme inhibitors(ACEI) Drug: lotensin 0.2-0.3mg/kg/d (the maximum dose is 20mg)
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
1.5mg/kg/d
Intervention Type
Drug
Intervention Name(s)
ACEI
Other Intervention Name(s)
Lotensin
Intervention Description
0.2-0.3mg/kg/d
Primary Outcome Measure Information:
Title
Disappearance of proteinuria
Description
The proteinuria is < 150mg/d
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Disappearance of hematuria
Description
The number of red blood cells is < 3 in each high power field of vision
Time Frame
30 months
Title
Renal function
Description
The glomerular filtration rate is normal
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aihua Zhang, M.D.
Phone
+8618951769017
Email
bszah@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yimei Wu
Phone
+8615951757930
Email
wym891203@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aihua Zhang, M.D.
Organizational Affiliation
Department of Nephrology, Nanjing children's hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Children's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aihua Zhang, M.D.
Phone
+8618951769017
Email
bszah@163.com
12. IPD Sharing Statement
Learn more about this trial
The Research of Standard Diagnosis and Treatment for HSPN With Mild Proteinuria in Children
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