Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance

Completed · Phase 4 · Has a placebo group

Conditions studied: Renal Transplantation

In brief

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

Key facts

Study ID

NCT00400400

Run by

Novartis Pharmaceuticals

People needed

400

Starts

2006-10-01

Last updated by the study team

2011-08-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females aged 18-75 years, Recipients of first or second cadaveric, living unrelated or living related kidney transplant
• 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.

You may not qualify if…

• Multi-organ transplant patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (second kidney transplant is allowed)
• 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.
• Other protocol defined inclusion/exclusion criteria may apply.

Where it is running

• 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
• AKDHC Medical Research Services, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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