The Research of Standard Diagnosis and Treatment for HSPN in Children
1 other identifier
interventional
100
1 country
1
Brief Summary
This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFebruary 26, 2020
February 1, 2020
4.9 years
August 20, 2015
February 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Disappearance of proteinuria
The proteinuria is \< 150mg/d
30 mo
Secondary Outcomes (2)
Disappearance of hematuria
30 mo
Renal function
30 mo
Study Arms (3)
Prednisone & Cyclophosphamide
EXPERIMENTALDrug: 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.
Prednisone & Mycophenolate mofetil
EXPERIMENTALDrug: 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.
Prednisone & Leflunomide
EXPERIMENTALDrug: 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.
Interventions
Eligibility Criteria
You may qualify if:
- Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d
You may not qualify if:
- The children with congenital diseases Proteinuria \< 50 mg/kg/d
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Children's Hospital
Nanjing, Jiangsu, 210000, China
Related Publications (1)
Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.
PMID: 36853224DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aihua Zhang, M.D.
Department of Nephrology, Nanjing children's hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hospital vice president
Study Record Dates
First Submitted
August 20, 2015
First Posted
August 26, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
February 26, 2020
Record last verified: 2020-02