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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02554955
Collaborator
(none)
36
Enrollment
14
Locations
1
Arm
46
Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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.
Other Names:
  • Zenapax

    • Drug: 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.
    Other Names:
  • CellCept

    • Drug: Silrolimus
    Participants will receive sirolimus orally (3 mg/day) for 6 months.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants with reported biopsy proven acute rejection episodes [up to 6 months]

    Secondary Outcome Measures

    1. Incidence of adverse events [up to 6 months]

    2. Incidence of Opportunistic Infections [Up to 5 years post transplant]

    3. Patient and graft survival [up to 6 months]

    4. Number of participants with malignancies [up to 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barcelona Spain 08025
    2 Barcelona Spain 08036
    3 El Palmar Murcia Spain 30120
    4 Hospitalet de Llobregat Spain 08907
    5 La Coruna Spain 15006
    6 Madrid Spain 28007
    7 Madrid Spain 28035
    8 Madrid Spain 28041
    9 Oviedo Spain 33006
    10 Pamplona Spain 31008
    11 Santander Spain 39008
    12 Sevilla Spain 41013
    13 Valencia Spain 46009
    14 Valladolid Spain 47005

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Chair: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02554955
    Other Study ID Numbers:
    • ML17910
    First Posted:
    Sep 18, 2015
    Last Update Posted:
    Nov 2, 2016
    Last Verified:
    Nov 1, 2016
    Additional relevant MeSH terms:
    Mycophenolic Acid
    Daclizumab

    Study Results

    No Results Posted as of Nov 2, 2016