Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
Condition: Heart Diseases; Heart Transplantation
MeSH terms: Heart Diseases
Intervention: Tacrolimus; Cyclosporine; Mycophenolate mofetil; Methylprednisolone; Prednisone
Intervention description: Oral; Oral; Intravenous and Oral; Intravenous; Oral
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisone; Methylprednisolone; Tacrolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 111.0
Sex: All
Healthy volunteers: No
Keywords: Antirejection; Treatment Outcome; Immunosuppression; Treatment Effectiveness; Anti-rejection therapy

Summary:

      The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart
      transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients (or their legal guardians) who are capable of understanding, and who have
             been fully informed of the purpose of the study and the risks of participation.

          -  Patients (or their legal guardians) who have signed and dated the Informed Consent
             form and are willing and able to follow the study protocol.

          -  Patients who are primary cadaveric heart transplant recipients.

          -  Males or females from birth.

          -  Female patients of child-bearing potential who have a current negative pregnancy test
             and agree to practice effective birth control, as judged by the investigator, while
             participating in the study. Prepubescent pediatric patients will not require pregnancy
             testing.

          -  Patients able to tolerate oral medication and who do not have a gastrointestinal
             condition likely to affect the absorption kinetics or metabolism of the oral study
             medications.

        Exclusion Criteria:

          -  Previous organ transplant recipients.

          -  Multi-organ transplant recipients.

          -  Recipients of a heart from a donor with incompatible ABO blood type.

          -  Patients with significant graft dysfunction and/or significant de novo infection(s) at
             time of randomization

          -  Patients with known hypersensitivity to tacrolimus, cyclosporine, mycophenolate
             mofetil (MMF), daclizumab, prednisone, cremophor, polysorbate 80 and/or polyoxyl 60
             hydrogenated castor oil (HCO-60).

          -  Patients who are pregnant or lactating or planning to become pregnant prior to
             completion of the study.

          -  Patients who have consumed an investigational product in the 30 days prior to
             transplantation or at any time during post-transplantation follow-up.

          -  Patients receiving cholestyramine or colestipol.

          -  Patients having any one of the following at enrolment:

               1. History of malignancy, not chart-documented as cured or active malignancy (with
                  exception of eradicable non-metastatic in-situ basal cell or squamous cell
                  carcinoma).

               2. Leukopenia (white cell count < 2500/cu mm).

               3. Anemia (hemoglobin < 80 g/L).

               4. Positive test for hepatitis B surface antigen and/or hepatitis C.

               5. Historical positive test for human immunodeficiency virus (HIV).

               6. Serum creatinine > 230 umol/l.

               7. Continual elevation of AST and/or ALT to >= 3X the upper limit of normal.

               8. Body mass index (weight in kg/height in m2) > 30.

          -  Undiagnosed diabetes mellitus as determined by 2 hour (2h) oral glucose tolerance test
             (OGTT) or fasting glucose test or uncontrolled diabetes mellitus at screening. In
             either case, the patient may be declared as no longer excluded by this criterion upon
             establishment of control of the diabetes through appropriate medical management.

          -  Blood glucose >= 11.1 mmol/L at pre-operative assessment.

          -  Patients having a significant disease, substance dependency, or disability that may
             prevent adherence to, or understanding of, the protocol and/or the investigator's
             instructions.