Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients
Condition: Transplants and Implants
Intervention: Enteric coated mycophenolate sodium; Mycophenolate mofetil
Intervention description: Patients in this group will receive Myfortic (enteric-coated mycophenolate sodium) in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.; Patients in this group will receive CellCept (mycophenolate mofetil) or its generic equivalent formulation manufactured by Sandoz, in combination with Thymoglobulin (rabbit Anti-thymocyte globulin) induction immunosuppression, Prograf (tacrolimus) or its generic equivalent, and corticosteroid immunosuppression.
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study consisted of 2 parallel active comparator arms.
Masking: None (Open Label)
Masking description: Masking description is not applicable since no masking was used in this study.
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: African American; Kidney Transplant

Summary:

      Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness
      to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients.
      However, enteric coated mycophenolate sodium has been thought to possibly be associated with
      fewer gastrointestinal side effects. Mycophenolate mofetil and enteric coated mycophenolate
      sodium pharmacokinetics (how the drug is absorbed and broken down) have not been well-studied
      in African American kidney transplant recipients. The investigators are interested in
      studying enteric coated mycophenolate sodium and mycophenolate mofetil pharmacokinetics and
      gastrointestinal side effects in African American kidney transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipients of a deceased donor or living donor kidney transplant

          -  Recipients of age greater than 18 years but less than 76 years

          -  African Americans (self-reported patients of Black African descent who live in the
             United States)

          -  Willingness to participate in a randomized, clinical trial, as indicated by signed
             informed consent

          -  Patients with a history of gastrointestinal complications including any of the
             following: a history of diarrhea, constipation, acid reflux, or abdominal pain as
             reported by the patient

          -  For women of childbearing age, effective contraception must be used before beginning
             CellCept or Myfortic, during therapy and 6 weeks after therapy has been discontinued
             (childbearing women should have a negative serum or urine pregnancy test within 1 week
             prior to starting CellCept or Myfortic therapy)

        Exclusion Criteria:

          -  Recipients with any prior solid organ transplant (including kidney)

          -  Recipients receiving a concurrent solid organ (heart, liver, pancreas) or cell (islet,
             bone marrow, stem cell) transplant

          -  Recipient age is less than 18 years old or greater than 75 years old

          -  Recipients who are not African American (self-reported patients of Black African
             descent who live in the United States)

          -  Recipients on proton pump inhibitor therapy at the time of initial screening
             (pre-transplant to 2 days post-transplant)

          -  Recipients with a gastrointestinal bleed within the past three months

          -  Recipients who are pregnant or breast feeding

          -  Recipients with known human immunodeficiency virus (HIV) infection

          -  Allergy to any of the immunosuppressant medications

          -  Concurrent investigational medication

          -  Any medical or psychosocial condition, which, in the opinion of the investigators,
             would hinder compliance with the study requirements

          -  Inability or unwillingness of patient to provide informed consent