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Heart TransplantationPhase 4NCT02554955

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

A Phase 4 study testing Daclizumab, Mycophenolate mofetil and Silrolimus in people with Heart Transplantation, run by Hoffmann-La Roche at 14 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Transplantation
What is being tested?
Daclizumab, Mycophenolate mofetil and Silrolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
14 sitesSpain
Study dates
Feb 2004to Dec 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants greater than 18 years of age
  • Single organ (heart) transplant recipients
  • At risk for post-transplant renal dysfunction

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Spain14 sites

  • Study site

    A Coruña, 15006

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08036

  • Study site

    El Palmar Murcia, 30120

  • Study site

    L'Hospitalet de Llobregat, 08907

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28035

  • Study site

    Madrid, 28041

  • Study site

    Oviedo, 33006

  • Study site

    Pamplona, 31008

  • Study site

    Santander, 39008

  • Study site

    Seville, 41013

  • Study site

    Valencia, 46009

  • Study site

    Valladolid, 47005

Other trials in Spain

About this study

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

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.

Being tested
Daclizumab, Mycophenolate mofetil, Silrolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaclizumabDrug

    Also called Zenapax

    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 mofetilDrug

    Also called CellCept

    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.

  • SilrolimusDrug

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

Study groups in NCT02554955
Study groupRoleWhat they receive
Daclizumab + Mycophenolate mofetilExperimentalParticipants 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.
Receives: Drug: Daclizumab; Drug: Mycophenolate mofetil; Drug: Silrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 6 months

Secondary outcomes (4)

  1. Incidence of adverse events

    Measured: up to 6 months

  2. Incidence of Opportunistic Infections

    Measured: Up to 5 years post transplant

  3. Patient and graft survival

    Measured: up to 6 months

  4. Number of participants with malignancies

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2015 (estimated)
  2. Study startFeb 2004
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02554955
Sponsor's protocol ID
ML17910
Status last verified
Nov 2016
First submitted
17 Sep 2015
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Daclizumab, Mycophenolate mofetil and Silrolimus in people with Heart Transplantation, run by Hoffmann-La Roche at 14 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with reported biopsy proven acute rejection episodes (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02554955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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