Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients
Condition: Kidney Transplant Recipients
Intervention: mycophenolic acid
Intervention description: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant.
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is specifically designed to determine whether the initiation of Myfortic 2 weeks
      prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy
      in low to moderate risk patients. Specifically, the addition of Myfortic pretransplant to
      Simulect induction will be compared to standard Myfortic therapy with Thymoglobulin induction
      starting at the time of transplant in kidney transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients capable of understanding the purposes and risks of the study.

          -  Patients who can give written informed consent, and who are willing and able to
             participate in the full course of the study.

          -  Women of childbearing potential must have a negative serum pregnancy test within the
             last 48 hours prior to receiving study medication.

          -  Women of childbearing potential must use two reliable forms of contraception
             simultaneously, unless they are status post bilateral tubal ligation, bilateral
             oophorectomy, or hysterectomy. Effective contraception must be used before beginning
             study drug therapy, for the duration of the study and for 6 weeks following completion
             of the study.

        Exclusion Criteria:

          -  Patients who are recipients of a multiple organ transplant or if the patient
             previously received and organ transplant.

          -  Patients who are recipients of A-B-O incompatible transplants, all
             complement-dependent cytotoxicity (CDC) crossmatch positive transplants.

          -  Sensitized patients [most recent anti-Human Leukocyte Antigens (HLA) Class I panel
             reactive antibody (PRA) ≥ 25% by a CDC-based assay].

          -  Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus
             (HBV) except for hepatitis B surface antibody positive.

          -  Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).

          -  Patient has uncontrolled concomitant infection or any other unstable medical condition
             that could interfere with the study objectives.

          -  Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of <
             1,500/mm3); and/or leucopoenia (< 2,500/mm3), or anemia (hemoglobin < 6 g/dL) prior to
             study inclusion.

          -  Patient is taking or has been taking an investigational drug in the 30 days prior to
             transplant.

          -  Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil,
             enteric-coated mycophenolic acid, rabbit anti-thymocyte globulin, or corticosteroids.

          -  Patients with severe diarrhea or other gastrointestinal disorders that might interfere
             with their ability to absorb oral medication; diabetic patients with previously
             diagnosed diabetic gastroenteropathy, or patients with active peptic ulcer disease.

          -  Patient is receiving chronic steroid therapy at the time of transplant.

          -  Patients with a history of malignancy within the last five years, except for
             successfully excised squamous or basal cell carcinoma of the skin.

          -  Patient is pregnant or lactating, where pregnancy is defined as the state of a female
             after conception and until the termination of gestation, confirmed by positive human
             Chorionic Gonadotropin (hCG) laboratory test.

          -  Patient has any form of substance abuse, psychiatric disorder or a condition that, in
             the opinion of the investigator, may invalidate communication with the investigator.

          -  Inability to cooperate or communicate with the investigator.