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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08025
      • El Palmar Murcia, Spain, 30120
      • Hospitalet de Llobregat, Spain, 08907
      • La Coruna, Spain, 15006
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Madrid, Spain, 28035
      • Oviedo, Spain, 33006
      • Pamplona, Spain, 31008
      • Santander, Spain, 39008
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46009
      • Valladolid, Spain, 47005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: up to 6 months
up to 6 months
Incidence of Opportunistic Infections
Time Frame: Up to 5 years post transplant
Up to 5 years post transplant
Patient and graft survival
Time Frame: up to 6 months
up to 6 months
Number of participants with malignancies
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML17910

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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