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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02554955

Enrollment

Registered

2015-09-18

Start date

2004-02-29

Completion date

2007-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

Brief 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.

Interventions

DRUGDaclizumab

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.

DRUGMycophenolate mofetil

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.

DRUGSilrolimus

Participants will receive sirolimus orally (3 mg/day) for 6 months.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percentage of participants with reported biopsy proven acute rejection episodes	up to 6 months

Secondary

Measure	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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026