Clinical Trial Protocol Registry
A Study of CellCept (Mycophenolate Mofetil) and Zenapax in Prevention of Acute Rejection in Heart Transplant Patients
- Protocol number:
- Hoffmann-La Roche
- Company division:
- Official Scientific Title:
- An open-label pilot study of Zenapax in combination with CellCept and sirolimus on the prevention of acute rejection in patients receiving a heart transplant at risk of impaired kidney function
- Brief summary:
- This study will evaluate the efficacy and safety of intravenous Zenapax in combination with oral CellCept and oral sirolimus in patients receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 36.
- Study phase:
- Study type:
- Interventional; Treatment; Non-randomized; Open Label; Uncontrolled; Single group; Safety/efficacy study
- Heart Transplantation
- Primary outcome:
- Efficacy: Proportion of patients experiencing a biopsy-proven acute rejection episode at end of study\n\n
- Key secondary outcomes:
- Safety; Adverse events, laboratory abnormalities, opportunistic infections, patient and graft survival, malignancies\n
- Inclusion criteria:
- adult patients >=18 years of age;
- single organ (heart) transplant recipients;
- at risk for post-transplant renal dysfunction.
- Exclusion criteria:
- previous organ transplant;
- previous treatment with CellCept, Zenapax 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.
- Males or Females
- Age limits:
- Min: 18 years Max: N/A (No limit)
- Accepts healthy volunteers:
- Anticipated start date:
- February, 2004
- Trial registration date:
- Date last updated:
- EL PALMAR MURCIA
- HOSPITALET DE LLOBREGAT
- LA CORUNA
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