A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
NCT ID: NCT00658333
Last Updated: 2012-08-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE4
30 participants
INTERVENTIONAL
2008-03-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Enteric-coated Mycophenolate Acid
Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
Enteric-coated Mycophenolate Acid (EC-MPA)
Placebo MMF
Mycophenolate Mofetil
Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
Mycophenolate Mofetil (MMF)
Placebo EC-MPA
Interventions
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Enteric-coated Mycophenolate Acid (EC-MPA)
Mycophenolate Mofetil (MMF)
Placebo MMF
Placebo EC-MPA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients on a reduced daily dose (500mg to 1500mg) of MMF with existing but tolerable and controlled gastrointestinal symptoms.
* Recipients who are at least 4 weeks post renal transplantation with stable renal function.
Exclusion Criteria
* History of GI disorder prior to transplant
* Evidence of GI disorder induced by infection, underlying medical condition, or con med other than MMF
* Modification of GI med or MMF dose within one week
* Evidence of graft rejection, treatment of acute rejection, unstable renal function within 1 week of (baseline) visit
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis
Phoenix, Arizona, United States
Novartis
Los Angeles, California, United States
Novartis
Los Angeles, California, United States
Novartis
Los Angeles, California, United States
Novartis
Orange, California, United States
Novartis
San Diego, California, United States
Novartis
San Francisco, California, United States
Novartis
Aurora, Colorado, United States
Novartis
Washington D.C., District of Columbia, United States
Novartis
Orlando, Florida, United States
Novartis
New Orleans, Louisiana, United States
Novartis
Portland, Maine, United States
Novartis
Baltimore, Maryland, United States
Novartis
Boston, Massachusetts, United States
Novartis
Boston, Massachusetts, United States
Novartis
Springfield, Massachusetts, United States
Novarits
Detroit, Michigan, United States
Novartis
New York, New York, United States
Novartis
New York, New York, United States
Novartis
New York, New York, United States
Novartis
Charlotte, North Carolina, United States
Novartis
Durham, North Carolina, United States
Novartis
Greenville, North Carolina, United States
Novartis
Winston-Salem, North Carolina, United States
Novarits
Fargo, North Dakota, United States
Novartis
Cleveland, Ohio, United States
Novartis
Portland, Oregon, United States
Novartis
Portland, Oregon, United States
Novartis
Philadelphia, Pennsylvania, United States
Novartis
Providence, Rhode Island, United States
Novartis
Nashville, Tennessee, United States
Novartis
Dallas, Texas, United States
Novartis
Houston, Texas, United States
Novartis
Temple, Texas, United States
Novartis
Murray, Utah, United States
Novartis
Burlington, Vermont, United States
Novartis
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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CERL080AUS67
Identifier Type: -
Identifier Source: org_study_id