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
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
1 other identifier
interventional
30
1 country
37
Brief Summary
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2008
Shorter than P25 for phase_4
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
March 11, 2011
CompletedAugust 7, 2012
July 1, 2012
1 year
January 23, 2008
December 2, 2010
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Response (Yes/no)
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.
6 weeks
Secondary Outcomes (1)
Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals
Baseline and week 4 to week 6
Study Arms (2)
Enteric-coated Mycophenolate Acid
EXPERIMENTALEquimolar 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.
Mycophenolate Mofetil
ACTIVE COMPARATORMycophenolate 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.
Interventions
Eligibility Criteria
You may qualify if:
- Recipients of first or second cadaveric, living unrelated or living related kidney transplant.
- 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.
You may not qualify if:
- Multi organ transplant or previous transplant with organ other than kidney
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Novartis
Phoenix, Arizona, 85012, United States
Novartis
Los Angeles, California, 90033, United States
Novartis
Los Angeles, California, 90057, United States
Novartis
Los Angeles, California, 90095, United States
Novartis
Orange, California, 92868, United States
Novartis
San Diego, California, 92123, United States
Novartis
San Francisco, California, 94143, United States
Novartis
Aurora, Colorado, 80010, United States
Novartis
Washington D.C., District of Columbia, 20007, United States
Novartis
Orlando, Florida, 32804, United States
Novartis
New Orleans, Louisiana, 70121, United States
Novartis
Portland, Maine, 04102, United States
Novartis
Baltimore, Maryland, 21201, United States
Novartis
Boston, Massachusetts, 02114, United States
Novartis
Boston, Massachusetts, 02215, United States
Novartis
Springfield, Massachusetts, 01107, United States
Novarits
Detroit, Michigan, 48236, United States
Novartis
New York, New York, 10029, United States
Novartis
New York, New York, 10032, United States
Novartis
New York, New York, 10065, United States
Novartis
Charlotte, North Carolina, 28207, United States
Novartis
Durham, North Carolina, 27710, United States
Novartis
Greenville, North Carolina, 27834, United States
Novartis
Winston-Salem, North Carolina, 27103, United States
Novarits
Fargo, North Dakota, 58123, United States
Novartis
Cleveland, Ohio, 44106, United States
Novartis
Portland, Oregon, 97210, United States
Novartis
Portland, Oregon, 97239, United States
Novartis
Philadelphia, Pennsylvania, 19140, United States
Novartis
Providence, Rhode Island, 02903, United States
Novartis
Nashville, Tennessee, 37232, United States
Novartis
Dallas, Texas, 75230, United States
Novartis
Houston, Texas, 77054, United States
Novartis
Temple, Texas, 76508, United States
Novartis
Murray, Utah, 84107, United States
Novartis
Burlington, Vermont, 05401, United States
Novartis
Charlottesville, Virginia, 22908, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the insufficient number of patients enrolled in the study, no conclusions can be made from the data.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
April 15, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
August 7, 2012
Results First Posted
March 11, 2011
Record last verified: 2012-07