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

Roche

Status and phase: Completed; Phase 4

Conditions: Heart Transplantation

Treatments: Drug: Mycophenolate mofetil; Drug: Silrolimus; Drug: Daclizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02554955

ML17910

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Daclizumab + Mycophenolate mofetil

Experimental group

Description:

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.

Treatment:

Drug: Silrolimus

Drug: Daclizumab

Drug: Mycophenolate mofetil