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:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Transplantation
| 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 :
- 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 :
- 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).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
| 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
| 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:
|
Mycophenolic Acid Antibiotics, Antineoplastic Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents |
Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |