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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00425724 |
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Date of registration:
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22/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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HSP-glomerulonephritis Trial: MP vs CyA
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Scientific title:
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Date of first enrolment:
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January 2000 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00425724 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Finland
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Contacts
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Name:
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Matti Nuutinen, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. of Pediatrics, Oulu University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- On the basis of a renal biopsy, the patient has been diagnosed for crescentic HSP
glomerulonephritis of ISKDC grade III or IV or HSP glomerulonephritis of ISKDC grade
II + a definite nephrotic syndrome (proteinuria > 40 mg/m2/h).
Exclusion Criteria:
- The child is on regular medication known to interact with cyclosporine. Such
medication includes cisapride, phenytoin, phenobarbital, carbamazepine, digoxin and
anti-inflammatory pain medication.
Age minimum:
2 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Purpura, Schoenlein-Henoch
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Intervention(s)
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Drug: Methylprednisolone pulses plus prednisone versus Cyclosporine A
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Primary Outcome(s)
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Renal function (measured by Cr-EDTA-Cl- GFR)
[Time Frame: 24 mo]
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Disappearance of proteinuria/ hematuria
[Time Frame: 24 mo]
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Renal biopsy findings
[Time Frame: 24 mo]
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Secondary Outcome(s)
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Need for additional medication
[Time Frame: 24 mo]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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