Trial information
A Study of CellCept (Mycophenolate Mofetil) and Zenapax in Prevention of Acute Rejection in Heart Transplant Patients
Status: Completed
Protocol number: ML17910
Sponsor: Roche Farma SA
Company division: Pharmaceutical
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 44.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Heart Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Efficacy: Proportion of patients experiencing a biopsy-proven acute rejection episode at end of study
Key secondary outcomes: 1. Safety; Adverse events, laboratory abnormalities, opportunistic infections, patient and graft survival, malignancies
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Spain
- Barcelona
- Madrid
- Pamplona
- Santander
- Sevilla
