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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COMPLETED
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2002-05-31
Brief Summary
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In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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mycophenolate mofetil orally 1000 mg twice a day (BID)
prednisone 0,5 mg/kg orally on alternate days
intravenous (i.v.) methylprednisolone 1000 mg, total 9
Eligibility Criteria
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Inclusion Criteria
* Serum creatinine (Screat)\> 1,5 mg/dl or ECC \< 70 ml/min or increase Screat \> 50%
* Proteinuria \> 2 g/day
Exclusion Criteria
* Pregnancy wish
* Active infection
* Liver dysfunction
* Abnormal hematology lab
* Unstable angina
* Nonsteroidal anti-inflammatory agents (NSAIDs)
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Radboud University Medical Center
OTHER
Principal Investigators
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Jack F Wetzels, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Department of Nephrology Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Countries
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References
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Branten AJ, du Buf-Vereijken PW, Vervloet M, Wetzels JF. Mycophenolate mofetil in idiopathic membranous nephropathy: a clinical trial with comparison to a historic control group treated with cyclophosphamide. Am J Kidney Dis. 2007 Aug;50(2):248-56. doi: 10.1053/j.ajkd.2007.05.015.
Other Identifiers
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RUNMN02
Identifier Type: -
Identifier Source: org_study_id