Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
Condition: Renal Transplantation
Intervention: Enteric-coated mycophenolate sodium (EC-MPS); Mycophenolate mofetil; Placebo to mycophenolate sodium; Placebo to mycophenolate mofetil
Intervention description: Enteric-coated mycophenolate sodium supplied as 180 mg tablets.; Mycophenolate mofetil supplied as 250 mg capsules.; Placebo to mycophenolate sodium matching tablets.; Placebo to mycophenolate mofetil matching capsules.
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: RenalTransplantation; KidneyTransplantation; MPA; EC-MPS

Summary:

      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).
    

Eligibility criteria:

        Inclusion criteria:

          -  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.

        Exclusion criteria:

          -  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.