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
NCT00658333 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2012-08-07
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
Conditions
- Renal Transplantation
Interventions
- DRUG
-
Enteric-coated Mycophenolate Acid (EC-MPA)
- DRUG
-
Mycophenolate Mofetil (MMF)
- DRUG
-
Placebo MMF
- DRUG
-
Placebo EC-MPA
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
Countries
- United States
Study Locations
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