Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
NCT ID: NCT00400400
Last Updated: 2011-08-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
400 participants
INTERVENTIONAL
2006-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance
NCT00150020
Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation
NCT00239005
Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil
NCT00400647
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
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
NCT00149942
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enteric-coated mycophenolate sodium
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
Enteric-coated mycophenolate sodium (EC-MPS)
Enteric-coated mycophenolate sodium supplied as 180 mg tablets.
Placebo to mycophenolate mofetil
Placebo to mycophenolate mofetil matching capsules.
Mycophenolate mofetil
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
Mycophenolate mofetil
Mycophenolate mofetil supplied as 250 mg capsules.
Placebo to mycophenolate sodium
Placebo to mycophenolate sodium matching tablets.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enteric-coated mycophenolate sodium (EC-MPS)
Enteric-coated mycophenolate sodium supplied as 180 mg tablets.
Mycophenolate mofetil
Mycophenolate mofetil supplied as 250 mg capsules.
Placebo to mycophenolate sodium
Placebo to mycophenolate sodium matching tablets.
Placebo to mycophenolate mofetil
Placebo to mycophenolate mofetil matching capsules.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Recipients who are at least 4 weeks post renal transplantation with stable renal function, Patients currently receiving MMF (all dosages are allowed) and either cyclosporine USP (MODIFIED) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks prior to study start
* Patients with at least one mild and/or moderate and/or severe upper or lower gastrointestinal (GI) complaints clearly associated with MMF therapy as determined by the treating physician. Additional mild GI complaints may coexist
* Patients' immunosuppressive regimen other than steroids (doses and type) as well as medication for treatment of GI symptoms must be unchanged for at least 1 week prior to study start
* Females of childbearing potential must have a negative pregnancy test prior to the inclusion period. The test should be performed locally at Baseline visit. If positive, the patient will not be included. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication
* Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Exclusion Criteria
* History of GI disorder (diarrhea, Gastroesophageal Reflux Disease (GERD), dyspepsia, Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS) prior to transplantation
* Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MMF, Modification of GI medication or MMF dose within last 1 week
* Evidence of graft rejection, treatment of acute rejection, or unstable renal function within 4 weeks prior to the Baseline visit, Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry
* Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
* Pregnant or nursing (lactating) women, Women of child-bearing potential (WOCBP) not using an acceptable method of contraception such as: surgical sterilization, hormonal contraception, or double-barrier methods.
* Contraception should be maintained throughout the study and for 4 weeks after study drug discontinuation.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Novartis Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis
Role: STUDY_DIRECTOR
Novartis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
National Institute of Transplantation
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
University of California, San Diego
San Diego, California, United States
University of California
San Francisco, California, United States
Denver Nephrology
Denver, Colorado, United States
University of Colorado Health Science Center
Denver, Colorado, United States
Yale University Transplantation
New Haven, Connecticut, United States
Washington Hospital Transplant Research
Washington D.C., District of Columbia, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Clarian Health Partners
Indianapolis, Indiana, United States
Univ of KS Medical Ctr
Kansas City, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, United States
WKHS/LSUHSC Regional Transplant Center
Shreveport, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Mid-Atlantic Nephrology Associates
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
St. John Hospital Medical Center
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
St. Baranabas Medical Center
Livingston, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Tennessee Health Science Center
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
CRSTI
Dallas, Texas, United States
Baylor All Saints
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CERL080AUS51
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.