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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclizumab + Mycophenolate mofetil | Experimental | Participants will receive intravenous (IV) daclizumab (2 milligrams per kilogram [mg/kg] within 6 hours after transplantation and 1 mg/kg every 2 weeks for a total of five doses), along with mycophenolate mofetil (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg twice daily [BID] within first week and 1 grams per day [g/day] BID from second week onwards) and sirolimus (3 mg/day) for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclizumab | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with reported biopsy proven acute rejection episodes | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | up to 6 months | |
| Incidence of Opportunistic Infections | Up to 5 years post transplant | |
| Patient and graft survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A Coruña | 15006 | Spain | ||||
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|
| Mycophenolate mofetil | Drug | 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. |
|
|
| Silrolimus | Drug | Participants will receive sirolimus orally (3 mg/day) for 6 months. |
|
| up to 6 months |
| Number of participants with malignancies | up to 6 months |
| Barcelona |
| 08025 |
| Spain |
| Barcelona | 08036 | Spain |
| El Palmar Murcia | 30120 | Spain |
| L'Hospitalet de Llobregat | 08907 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28035 | Spain |
| Madrid | 28041 | Spain |
| Oviedo | 33006 | Spain |
| Pamplona | 31008 | Spain |
| Santander | 39008 | Spain |
| Seville | 41013 | Spain |
| Valencia | 46009 | Spain |
| Valladolid | 47005 | Spain |
| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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