Liver Transplant European Study Into the Prevention of Fungal Infection
TENPIN
Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients
2 other identifiers
interventional
350
14 countries
36
Brief Summary
Prevention of invasive fungal infection in high risk patients following liver transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2009
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2009
CompletedFirst Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2012
CompletedNovember 18, 2024
November 1, 2024
2.4 years
January 26, 2010
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
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
3 months
Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator
up to 21 days & 3 months
Time to 'proven' or 'probable' IFD
up to 3 months
Fungal free survival at the End of Study and at the end of Long-term Follow-up
3 months & 6 months
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline
up to 21 days
Study Arms (2)
micafungin
EXPERIMENTALintravenous infusion
standard care
ACTIVE COMPARATORintravenous infusion
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Innsbruck, 6020, Austria
Unknown Facility
Antwerp, 2650, Belgium
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Paris, Villejuif Cedex, 94804, France
Unknown Facility
Clichy, 32110, France
Unknown Facility
Paris, 75013, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Hamburg, 20246, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Heidelberg, 69120, Germany
Unknown Facility
Budapest, 1082, Hungary
Unknown Facility
Dublin, 4, Ireland
Unknown Facility
Milan, 20146, Italy
Unknown Facility
Padua, 35127, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Udine, 33100, Italy
Unknown Facility
Coimbra, 3000-075, Portugal
Unknown Facility
Porto, 4099-001, Portugal
Unknown Facility
Bucharest, 22328, Romania
Unknown Facility
Moscow, 123182, Russia
Unknown Facility
Moscow, 129090, Russia
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Saint Petersburg, 197758, Russia
Unknown Facility
Riyadh, Saudi Arabia
Unknown Facility
Santiago de Compostela, A Coruna, 15706, Spain
Unknown Facility
Barakald, Vicaya, 48903, Spain
Unknown Facility
Barcelona, 08036, Spain
Unknown Facility
Córdoba, 14004, Spain
Unknown Facility
Madrid, 28007, Spain
Unknown Facility
Madrid, 28034, Spain
Unknown Facility
Valencia, 46009, Spain
Unknown Facility
Stockholm, 14186, Sweden
Unknown Facility
Birmingham, B15 2TH, United Kingdom
Unknown Facility
London, SE5 9RS, United Kingdom
Related Publications (1)
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.
PMID: 25520332DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 28, 2010
Study Start
December 15, 2009
Primary Completion
May 3, 2012
Study Completion
May 3, 2012
Last Updated
November 18, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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/.