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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
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.
Time frame: 6 weeks
Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals
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).
Time frame: Baseline and week 4 to week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 27 more locations