This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 6 months, and the target sample size is 44 individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Participants will receive IV daclizumab (2 mg/kg within 6 hours after transplantation and 1 mg/kg every 2 weeks) for a total of five doses.
Participants will receive mycophenolate mofetil orally (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg BID within first week and 1 g/day BID from second week onwards) for 6 months.
Participants will receive sirolimus orally (3 mg/day) for 6 months.
Unnamed facility
A Coruña, Spain
Unnamed facility
Barcelona, Spain
Unnamed facility
Barcelona, Spain
Unnamed facility
El Palmar Murcia, Spain
Percentage of participants with reported biopsy proven acute rejection episodes
Time frame: up to 6 months
Incidence of adverse events
Time frame: up to 6 months
Incidence of Opportunistic Infections
Time frame: Up to 5 years post transplant
Patient and graft survival
Time frame: up to 6 months
Number of participants with malignancies
Time frame: up to 6 months
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Unnamed facility
L'Hospitalet de Llobregat, Spain
Unnamed facility
Madrid, Spain
Unnamed facility
Madrid, Spain
Unnamed facility
Madrid, Spain
Unnamed facility
Oviedo, Spain
Unnamed facility
Pamplona, Spain
...and 4 more locations