Transcript Slide 1
RAD
Immunosuppression in Heart Transplant
Recipients
Duke Heart Failure Research
Pager: 970-0736
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
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.
Interventions
Investigational drug:
Everolimus (Certican)
Control drug:
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.
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
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.
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.
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)