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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Daclizumab; Everolimus; Immunoglobulin G; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

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