Heart Transplantation
Conditions
Brief summary
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
Interventions
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult (\>=18 years of age) heart transplant patients (4-6 weeks post-transplant); * receipt of first heart (single-organ) transplant; * standard care regimen of CNI, MMF, and corticosteroids since transplantation.
Exclusion criteria
* positive donor-specific cross-match at time of transplantation; * history of malignancies, other than non-melanoma skin cancer that has been totally excised with no recurrence for 2 years; * patients participating in another interventional clinical trial or requiring treatment with unmarketed investigational drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of BPAR, number of episodes of BPAR per patient, time to first BPAR, incidence of re-transplant, death, rejection including antibody treated rejection, time to graft loss or death, rejection associated with HDC\n | — |
Countries
Australia, Austria, France, Germany, Spain, United States
Outcome results
None listed