Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS
NCT ID: NCT01801280
Last Updated: 2019-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2012-01-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Mycophenolate mofetil (C)
Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks.
Mycophenolate mofetil
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
Mycophenolate mofetil+Pantoprazole (C+P)
Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks.
Pantoprazole
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Mycophenolate mofetil
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
Mycophenolate sodium (M)
Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks.
Mycophenolate sodium
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
Mycophenolate sodium+Pantoprazole (M+P)
Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks.
Mycophenolate sodium
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
Pantoprazole
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Interventions
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Mycophenolate sodium
Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
Pantoprazole
Daily dose: 40mg. Application together with CellCept® or Myfortic® .
Mycophenolate mofetil
Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients who are on stable immunosuppressive therapy for at least one month with ciclosporin, EC-MPS or MMF +/- corticosteroids
* renal transplantation, at least 6 months prior study inclusion
* suitable and willing to switch treatment according to the study plan
* women of childbearing potential must have a negative serum pregnancy test before study start and effective contraception must be used (method with PEARL index \<1%)
Exclusion Criteria
* patients who are not on stable treatment with enzyme inductors or enzyme inhibitors for \<1 month before study entry
* patients who take medication which is known for interfering with MPA absorption for \<1 month before study entry
* known anamnestic hypersensitivity to one of the investigational products or drugs with similar chemical structure and to other components of the investigational products, respectively
* patients on treatment with clopidogrel
* acute rejection \< 1 month before study inclusion
* patients who are HIV positive, hepatitis C virus (HCV) positive, HBsAg positive
* patients with gastrointestinal disorders which could affect resorption
* pregnancy and/or lactation
* drug or alcohol abuse in patient's history
* patients with history of psychological illness or condition, which might interfere with the ability to understand the requirements, consequences, possible outcome of the study and patients who are not willing to give valid informed consent
* patients with insufficient co-operation with the clinical investigator (e.g. suspicion of non-compliance)
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Klemens Budde
OTHER
Responsible Party
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Klemens Budde
Professor Dr Klemens Budde
Principal Investigators
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Klemens Budde, Prof Dr
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité Hospital Campus Mitte
Berlin, , Germany
Countries
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Other Identifiers
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2010-021275-92
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CERL 080A DE 20 T
Identifier Type: -
Identifier Source: org_study_id
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