Liver TransplantationPhase 3TENPINNCT01058174
Liver Transplant European Study Into the Prevention of Fungal Infection
A Phase 3 study testing micafungin, fluconazole and liposomal amphotericin B in people with Liver Transplantation and Mycoses, run by Astellas Pharma Inc at 36 sites in 14 countries.
Trial summary
Prevention of invasive fungal infection in high risk patients following liver transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Mycoses
- What is being tested?
- micafungin, fluconazole and liposomal amphotericin B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 36 sitesin 14 countries
- Study dates
- 15 Dec 2009to 3 May 2012
- Phase
- Phase 3
- 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
- Undergoing orthotopic whole or split liver allograft transplantation
- Patients at 'high risk' of invasive fungal infection due to the presence of at least one of the following risk factors:
- Re-transplantation
- Acute liver failure
- Pre- or post-operative renal impairment (defined as creatinine clearance ≤40 ml/min) or need for renal replacement therapy
- Admission to Intensive Care Unit (ICU) for greater than 48 hours prior to liver transplant
Show all 12Show fewer
- Re-operation (abdominal surgery) within 5 days of liver transplant
- Presence of choledocojejunostomy
- Perioperative colonization with fungi, defined as two or more positive clinical site surveillance cultures for Candida spp., obtained within 96 hours before or after liver transplant
- Need for prolonged mechanical ventilation for greater than 48 hours following liver transplant
- Transfusion intraoperatively of 20 or more units of cellular blood products
- Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain effective birth control during the study
Who cannot join
- Any systemic antifungal therapy (excluding fluconazole or oral nystatin for a maximum of 7 days) within 14 days prior to randomization
- Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria)
- Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients
Trial locations and contacts
36 sites in 14 countries.
36 sites in 14 countries
Spain7 sites
Study site
Barakald, Vicaya, 48903
Study site
Barcelona, 08036
Study site
Córdoba, 14004
Study site
Madrid, 28007
Study site
Madrid, 28034
Study site
Santiago de Compostela, A Coruna, 15706
Study site
Valencia, 46009
Belgium4 sites
Study site
Antwerp, 2650
Study site
Brussels, 1070
Study site
Brussels, 1200
Study site
Ghent, 9000
France4 sites
Study site
Clichy, 32110
Study site
Paris, Villejuif Cedex, 94804
Study site
Paris, 75013
Study site
Toulouse, 31059
Germany4 sites
Study site
Berlin, 13353
Study site
Hamburg, 20246
Study site
Hanover, 30625
Study site
Heidelberg, 69120
Italy4 sites
Study site
Milan, 20146
Study site
Padova, 35127
Study site
Torino, 10126
Study site
Udine, 33100
Russia3 sites
Study site
Moscow, 123182
Study site
Moscow, 129090
Study site
Saint Petersburg, 197758
United Kingdom2 sites
Study site
Birmingham, B15 2TH
Study site
London, SE5 9RS
About this study
Official title: Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients
Prevention of invasive fungal infection in high risk patients following liver transplant.
Read the detailed description
After receiving liver transplant, subjects will be randomized to one of the two treatment arms.
Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first.
Additionally, mortality data will be collected at the Long-term Follow-up.
- Conditions
- Liver Transplantation, Mycoses
- Being tested
- micafungin, fluconazole, liposomal amphotericin B, caspofungin
- Keywords
- Prophylaxis, Liver transplantation, Invasive Fungal Infection, Micafungin, Prevention, Mycoses
- Medical subject headings
- Mycoses, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micafunginDrug
Also called Mycamine
intravenous infusion
fluconazoleDrug
Also called Diflucan
intravenous infusion
liposomal amphotericin BDrug
Also called AmBisome
intravenous infusion
caspofunginDrug
Also called Cancidas
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| micafungin | Experimental | intravenous infusion Receives: Drug: micafungin |
| standard care | Active comparator | intravenous infusion Receives: Drug: fluconazole; Drug: liposomal amphotericin B; Drug: caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
Measured: up to 21 days
Secondary outcomes (5)
Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB
Measured: 3 months
Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator
Measured: up to 21 days & 3 months
Time to 'proven' or 'probable' IFD
Measured: up to 3 months
Fungal free survival at the End of Study and at the end of Long-term Follow-up
Measured: 3 months & 6 months
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study start15 Dec 2009
- Primary completion3 May 2012
- Study completion3 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058174
- Sponsor's protocol ID
- 9463-EC-0001
- Other IDs
- 2008-005214-49, 2008
- Acronym
- TENPIN
- Status last verified
- Nov 2024
- First submitted
- 26 Jan 2010
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Saliba F, Pascher A, Cointault O, Laterre PF, Cervera C, De Waele JJ, Cillo U, Langer RM, Lugano M, Goran-Ericzon B, Phillips S, Tweddle L, Karas A, Brown M, Fischer L; TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators; TENPIN Liver Transplant European Study Into the Prevention of Fungal Infection Investigators. Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients. Clin Infect Dis. 2015 Apr 1;60(7):997-1006. doi: 10.1093/cid/ciu1128. Epub 2014 Dec 17.
PubMed 25520332
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT01058174
- Acronym / sponsor ID
- TENPIN / 9463-EC-0001
- Conditions
- Liver Transplantation, Mycoses
- Keywords
- Prophylaxis, Liver transplantation, Invasive Fungal Infection, Micafungin, Prevention, Mycoses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2009 (actual)
- Primary completion
- 3 May 2012 (actual)
- Study completion
- 3 May 2012 (actual)
- First posted
- 28 Jan 2010 (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.
Prevention of invasive fungal infection in high risk patients following liver transplant.
Detailed description
After receiving liver transplant, subjects will be randomized to one of the two treatment arms.
Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first.
Additionally, mortality data will be collected at the Long-term Follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| micafungin | Experimental | Drug: micafunginintravenous infusion |
| standard care | Active comparator | Drug: fluconazole, Drug: liposomal amphotericin B, Drug: caspofunginintravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Undergoing orthotopic whole or split liver allograft transplantation
- Patients at 'high risk' of invasive fungal infection due to the presence of at least one of the following risk factors:
- Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain effective birth control during the study
Key exclusion criteria (3 listed)
- Any systemic antifungal therapy (excluding fluconazole or oral nystatin for a maximum of 7 days) within 14 days prior to randomization
- Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria)
- Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients
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 |
|---|---|---|
| micafunginAlso: Mycamineintravenous infusion | Drug | micafungin |
| fluconazoleAlso: Diflucanintravenous infusion | Drug | standard care |
| liposomal amphotericin BAlso: AmBisomeintravenous infusion | Drug | standard care |
| caspofunginAlso: Cancidasintravenous infusion | Drug | standard care |
Primary outcome
'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
Time frame: up to 21 days
5 secondary outcomes
Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB
Time frame: 3 months
Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator
Time frame: up to 21 days & 3 months
Time to 'proven' or 'probable' IFD
Time frame: up to 3 months
Fungal free survival at the End of Study and at the end of Long-term Follow-up
Time frame: 3 months & 6 months
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline
Time frame: up to 21 days
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 18 Nov 2024.
- Derived from this study: PubMed 25520332Saliba F, Pascher A, Cointault O, Laterre PF, Cervera C, De Waele JJ, Cillo U, Langer RM, Lugano M, Goran-Ericzon B, Phillips S, Tweddle L, Karas A, Brown M, Fischer L; TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators; TENPIN Liver Transplant European Study Into the Prevention of Fungal Infection Investigators. Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients. Clin Infect Dis. 2015 Apr 1;60(7):997-1006. doi: 10.1093/cid/ciu1128. Epub 2014 Dec 17.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Use Central Contact study director
Astellas Pharma Europe Ltd.
36 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing micafungin, fluconazole and liposomal amphotericin B in people with Liver Transplantation and Mycoses, run by Astellas Pharma Inc at 36 sites in 14 countries.
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 12 inclusion and 3 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 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Spain, Belgium, France, Germany, Italy and 9 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). (time frame: up to 21 days). 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 NCT01058174, which also lists 1 linked publication.
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 18 Nov 2024.