Skip to main content
OpenTrials
Completed

NCT Number: NCT02554955

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Daclizumab

Drug

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

Mycophenolate mofetil

Drug

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

Silrolimus

Drug

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

Primary outcomes

  1. Percentage of participants with reported biopsy proven acute rejection episodes

    Time frame: up to 6 months

Secondary outcomes

  1. Incidence of adverse events

    Time frame: up to 6 months

  2. Incidence of Opportunistic Infections

    Time frame: Up to 5 years post transplant

  3. Patient and graft survival

    Time frame: up to 6 months

  4. Number of participants with malignancies

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 18, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.