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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
- Conditions
- Heart Transplantation
- 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.
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 group | Role | What they receive |
|---|---|---|
| Daclizumab + Mycophenolate mofetil | Experimental | 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. 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.
Percentage of participants with reported biopsy proven acute rejection episodes
Measured: up to 6 months
Secondary outcomes (4)
Incidence of adverse events
Measured: up to 6 months
Incidence of Opportunistic Infections
Measured: Up to 5 years post transplant
Patient and graft survival
Measured: up to 6 months
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.
- First posted18 Sep 2015 (estimated)
- Study startFeb 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02554955
- Acronym / sponsor ID
- ML17910
- Conditions
- Heart Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daclizumab + Mycophenolate mofetil | Experimental | Drug: Daclizumab, Drug: Mycophenolate mofetil, Drug: SilrolimusParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult participants greater than 18 years of age
- Single organ (heart) transplant recipients
- At risk for post-transplant renal dysfunction
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaclizumabAlso: ZenapaxParticipants 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. | Drug | Daclizumab + Mycophenolate mofetil |
| Mycophenolate mofetilAlso: CellCeptParticipants 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. | Drug | Daclizumab + Mycophenolate mofetil |
| SilrolimusParticipants will receive sirolimus orally (3 mg/day) for 6 months. | Drug | Daclizumab + Mycophenolate mofetil |
Primary outcome
Percentage of participants with reported biopsy proven acute rejection episodes
Time frame: up to 6 months
4 secondary outcomes
Incidence of adverse events
Time frame: up to 6 months
Incidence of Opportunistic Infections
Time frame: Up to 5 years post transplant
Patient and graft survival
Time frame: up to 6 months
Number of participants with malignancies
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
14 sites in 1 country: see every site and its status.
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?
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.