A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants

Study Overview
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Brief Summary
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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.

Official Title
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Pilot, Single-arm, Non-comparative, Open-label Study of Daclizumab in Combination With Mycophenolate Mofetil and Sirolimus in the Prevention of Acute Rejection in Cardiac Allografts Recipients in Risk of Deteriorated Renal Function

Conditions
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Heart Transplantation

Intervention / Treatment
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* Drug: Daclizumab
* Drug: Mycophenolate mofetil
* Drug: Silrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants greater than 18 years of age Single organ (heart) transplant recipients At risk for post-transplant renal dysfunction Exclusion Criteria: Previous organ transplant Previous treatment with mycophenolate mofetil, daclizumab or sirolimus Positive for human immunodeficiency virus (HIV) infection History of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daclizumab + Mycophenolate mofetil<br>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. | Drug: Daclizumab<br>* 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.<br>* Other names: Zenapax;Drug: Mycophenolate mofetil<br>* 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.<br>* Other names: CellCept;Drug: Silrolimus<br>* Participants will receive sirolimus orally (3 mg/day) for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with reported biopsy proven acute rejection episodes |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | up to 6 months | 
| Number of participants with malignancies |  | up to 6 months |