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Trial record 42 of 1195 for:    MYCOPHENOLIC ACID

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658333
Recruitment Status : Terminated
First Posted : April 15, 2008
Results First Posted : March 11, 2011
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658333


Locations
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United States, Arizona
Novartis
Phoenix, Arizona, United States, 85012
United States, California
Novartis
Los Angeles, California, United States, 90033
Novartis
Los Angeles, California, United States, 90057
Novartis
Los Angeles, California, United States, 90095
Novartis
Orange, California, United States, 92868
Novartis
San Diego, California, United States, 92123
Novartis
San Francisco, California, United States, 94143
United States, Colorado
Novartis
Aurora, Colorado, United States, 80010
United States, District of Columbia
Novartis
Washington, District of Columbia, United States, 20007
United States, Florida
Novartis
Orlando, Florida, United States, 32804
United States, Louisiana
Novartis
New Orleans, Louisiana, United States, 70121
United States, Maine
Novartis
Portland, Maine, United States, 04102
United States, Maryland
Novartis
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Novartis
Boston, Massachusetts, United States, 02114
Novartis
Boston, Massachusetts, United States, 02215
Novartis
Springfield, Massachusetts, United States, 01107
United States, Michigan
Novarits
Detroit, Michigan, United States, 48236
United States, New York
Novartis
New York, New York, United States, 10029
Novartis
New York, New York, United States, 10032
Novartis
New York, New York, United States, 10065
United States, North Carolina
Novartis
Charlotte, North Carolina, United States, 28207
Novartis
Durham, North Carolina, United States, 27710
Novartis
Greenville, North Carolina, United States, 27834
Novartis
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Novarits
Fargo, North Dakota, United States, 58123
United States, Ohio
Novartis
Cleveland, Ohio, United States, 44106
United States, Oregon
Novartis
Portland, Oregon, United States, 97210
Novartis
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novartis
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
Novartis
Providence, Rhode Island, United States, 02903
United States, Tennessee
Novartis
Nashville, Tennessee, United States, 37232
United States, Texas
Novartis
Dallas, Texas, United States, 75230
Novartis
Houston, Texas, United States, 77054
Novartis
Temple, Texas, United States, 76508
United States, Utah
Novartis
Murray, Utah, United States, 84107
United States, Vermont
Novartis
Burlington, Vermont, United States, 05401
United States, Virginia
Novartis
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00658333    
Other Study ID Numbers: CERL080AUS67
First Posted: April 15, 2008    Key Record Dates
Results First Posted: March 11, 2011
Last Update Posted: August 7, 2012
Last Verified: July 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Renal Transplantation
Immunosuppression
Renal transplant recipients
Gastrointestinal symptoms associated with MMF therapy
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action