The Research of Standard Diagnosis and Treatment for HSPN in Children
NCT ID: NCT02532777
Last Updated: 2020-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2015-08-31
2020-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Prednisone
Cyclophosphamide(CTX)
Angiotensin-converting enzyme inhibitor(ACEI)
Methylprednisolone
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.
Prednisone
Mycophenolate mofetil(MMF)
Angiotensin-converting enzyme inhibitor(ACEI)
Methylprednisolone
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.
Prednisone
Leflunomide(LEF)
Angiotensin-converting enzyme inhibitor(ACEI)
Methylprednisolone
Interventions
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Prednisone
Cyclophosphamide(CTX)
Mycophenolate mofetil(MMF)
Leflunomide(LEF)
Angiotensin-converting enzyme inhibitor(ACEI)
Methylprednisolone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2 Years
16 Years
ALL
No
Sponsors
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Nanjing Children's Hospital
OTHER
Responsible Party
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Aihua Zhang
Hospital vice president
Principal Investigators
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Aihua Zhang, M.D.
Role: STUDY_CHAIR
Department of Nephrology, Nanjing children's hospital
Locations
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Nanjing Children's Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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AZhang
Identifier Type: -
Identifier Source: org_study_id
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