A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants
NCT ID: NCT02554955
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
36 participants
INTERVENTIONAL
2004-02-29
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Daclizumab + Mycophenolate mofetil
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.
Daclizumab
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.
Mycophenolate 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.
Silrolimus
Participants will receive sirolimus orally (3 mg/day) for 6 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Daclizumab
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.
Mycophenolate 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.
Silrolimus
Participants will receive sirolimus orally (3 mg/day) for 6 months.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Single organ (heart) transplant recipients
* At risk for post-transplant renal dysfunction
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
A Coruña, , Spain
Barcelona, , Spain
Barcelona, , Spain
El Palmar Murcia, , Spain
L'Hospitalet de Llobregat, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Oviedo, , Spain
Pamplona, , Spain
Santander, , Spain
Seville, , Spain
Valencia, , Spain
Valladolid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML17910
Identifier Type: -
Identifier Source: org_study_id