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Liver Transplant European Study Into the Prevention of Fungal Infection (TENPIN)

Primary Purpose

Liver Transplantation, Mycoses

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
micafungin
fluconazole
liposomal amphotericin B
caspofungin
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplantation focused on measuring Prophylaxis, Liver transplantation, Invasive Fungal Infection, Micafungin, Prevention, Mycoses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

micafungin

standard care

Arm Description

intravenous infusion

intravenous infusion

Outcomes

Primary Outcome Measures

'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).

Secondary Outcome Measures

Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB
Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator
Time to 'proven' or 'probable' IFD
Fungal free survival at the End of Study and at the end of Long-term Follow-up
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline

Full Information

First Posted
January 26, 2010
Last Updated
March 8, 2019
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01058174
Brief Title
Liver Transplant European Study Into the Prevention of Fungal Infection
Acronym
TENPIN
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 15, 2009 (Actual)
Primary Completion Date
May 3, 2012 (Actual)
Study Completion Date
May 3, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Mycoses
Keywords
Prophylaxis, Liver transplantation, Invasive Fungal Infection, Micafungin, Prevention, Mycoses

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
micafungin
Arm Type
Experimental
Arm Description
intravenous infusion
Arm Title
standard care
Arm Type
Active Comparator
Arm Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
micafungin
Other Intervention Name(s)
Mycamine
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
fluconazole
Other Intervention Name(s)
Diflucan
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
liposomal amphotericin B
Other Intervention Name(s)
AmBisome
Intervention Description
intravenous infusion
Intervention Type
Drug
Intervention Name(s)
caspofungin
Other Intervention Name(s)
Cancidas
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB).
Time Frame
up to 21 days
Secondary Outcome Measure Information:
Title
Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB
Time Frame
3 months
Title
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
Title
Time to 'proven' or 'probable' IFD
Time Frame
up to 3 months
Title
Fungal free survival at the End of Study and at the end of Long-term Follow-up
Time Frame
3 months & 6 months
Title
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline
Time Frame
up to 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe Ltd.
Official's Role
Study Director
Facility Information:
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Paris
State/Province
Villejuif Cedex
ZIP/Postal Code
94804
Country
France
City
Clichy
ZIP/Postal Code
32110
Country
France
City
Paris
ZIP/Postal Code
75013
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
City
Dublin
ZIP/Postal Code
4
Country
Ireland
City
Milan
ZIP/Postal Code
20146
Country
Italy
City
Padova
ZIP/Postal Code
35127
Country
Italy
City
Torino
ZIP/Postal Code
10126
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
City
Riyadh
Country
Saudi Arabia
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
City
Barakald
State/Province
Vicaya
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
25520332
Citation
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=50
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

Liver Transplant European Study Into the Prevention of Fungal Infection

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