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RAD Immunosuppression in Heart Transplant Recipients Duke Heart Failure Research Pager: 970-0736
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Purpose Evaluate efficacy and safety comparing two concentrations of Certican with reduced Neoral dose vs. MMF* with standard Neoral dose in de novo heart transplant recipients This is a study of immunosuppressant drugs *Mycophenolate mofetil (Cellcept) = MMF
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Inclusion Criteria Male or female cardiac recipients 18-70 years old undergoing heart transplantation. Graft is functional at time of randomization. Females must have negative pregnancy test prior to randomization and use of effective contraception during the treatment and 3 months after medications are discontinued. This study is not currently enrolling.
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Interventions Investigational drug: Everolimus (Certican) Everolimus (Certican) Control drug: Mycophenolate mofetil (Cellcept) Mycophenolate mofetil (Cellcept) Both drugs in combination with Cyclosporine (Neoral) and corticosteroids. There is not a placebo in this study. These drugs are supplied by the investigational pharmacy except for the corticosteroids. Investigational pharmacy # 684-3543.
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Interventions Randomized to 1 of 3 groups 72 hours after transplantation Certican 0.75 mg BID, Neoral (reduced dose), steroids Certican 1.5 mg BID, Neoral (reduced dose), steroids MMF 1500 mg BID, Neoral (standard dose), steroids
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In Certican groups, therapeutic drug levels will be monitored throughout the study. Treatment lasts 24 months. No follow-up. Serious adverse effects are recorded for 4 weeks after the treatment ends.
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Nursing Roles If an enrolled subject is admitted to the hospital, please notify the research study team (970-0736) to obtain study medications. The admitting MD may enter a CPOE order stating patient may take home study meds x24 hrs until the study drugs can be obtained from the investigational pharmacy.
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Outcomes Why is this study being done? To compare the investigational drug Everolimus (Certican) with control drug Mycophenolate mofetil (Cellcept) to determine: Efficacy failure rates (evidence of acute rejection by biopsy) Rates of graft loss or re-transplant, death, or loss to follow-up Renal function (GFR)
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