Back to resultsThe Research of Standard Diagnosis and Treatment for HSPN in Children
Primary Purpose
Henoch-Schoenlein Purpura Nephritis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Prednisone
Cyclophosphamide(CTX)
Mycophenolate mofetil(MMF)
Leflunomide(LEF)
Angiotensin-converting enzyme inhibitor(ACEI)
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Henoch-Schoenlein Purpura Nephritis
Eligibility Criteria
Inclusion Criteria:
- Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d
Exclusion Criteria:
- The children with congenital diseases Proteinuria < 50 mg/kg/d
Sites / Locations
- Nanjing Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Prednisone & Cyclophosphamide
Prednisone & Mycophenolate mofetil
Prednisone & Leflunomide
Arm Description
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 & 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 & 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.
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
NCT02532777
First Posted
August 20, 2015
Last Updated
February 25, 2020
Sponsor
Nanjing Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02532777
Brief Title
The Research of Standard Diagnosis and Treatment for HSPN in Children
Official Title
The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis 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 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Henoch-Schoenlein Purpura Nephritis
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
Prednisone & Cyclophosphamide
Arm Type
Experimental
Arm Description
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.
Arm Title
Prednisone & Mycophenolate mofetil
Arm Type
Experimental
Arm Description
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.
Arm Title
Prednisone & Leflunomide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide(CTX)
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil(MMF)
Intervention Type
Drug
Intervention Name(s)
Leflunomide(LEF)
Intervention Type
Drug
Intervention Name(s)
Angiotensin-converting enzyme inhibitor(ACEI)
Other Intervention Name(s)
Lotensin
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Primary Outcome Measure Information:
Title
Disappearance of proteinuria
Description
The proteinuria is < 150mg/d
Time Frame
30 mo
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 mo
Title
Renal function
Description
The glomerular filtration rate is normal
Time Frame
30 mo
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 Proteinuria ≥ 50 mg/kg/d
Exclusion Criteria:
The children with congenital diseases Proteinuria < 50 mg/kg/d
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aihua Aihua, 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
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The Research of Standard Diagnosis and Treatment for HSPN in Children
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