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
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|ClinicalTrials.gov Identifier: NCT00658333|
Recruitment Status : Terminated
First Posted : April 15, 2008
Results First Posted : March 11, 2011
Last Update Posted : August 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplantation||Drug: Enteric-coated Mycophenolate Acid (EC-MPA) Drug: Mycophenolate Mofetil (MMF) Drug: Placebo MMF Drug: Placebo EC-MPA||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Double Blind, Double Dummy Controlled Study to Assess the Tolerability of an Increased Dose of Enteric Coated MPA After Conversion From MMF in Renal Transplant Recipients Who Required MMF Dose Reductions Due to Gastrointestinal Symptoms|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Experimental: 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.
Drug: Enteric-coated Mycophenolate Acid (EC-MPA)
Other Name: myfortic®
Drug: Placebo MMF
Active Comparator: 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.
Drug: Mycophenolate Mofetil (MMF)
Other Name: CellCept®
Drug: Placebo EC-MPA
- Number of Participants With Response (Yes/no) [ Time Frame: 6 weeks ]The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.
- Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals [ Time Frame: Baseline and week 4 to week 6 ]The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658333
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