ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01058174
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Prevention of invasive fungal infection in high risk patients following liver transplant.

Condition or disease Intervention/treatment Phase
Liver Transplantation Mycoses Drug: micafungin Drug: fluconazole Drug: liposomal amphotericin B Drug: caspofungin Phase 3

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 15, 2009
Actual Primary Completion Date : May 3, 2012
Actual Study Completion Date : May 3, 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: micafungin
intravenous infusion
 Drug: micafungin
intravenous infusion
Other Name: Mycamine
Active Comparator: standard care
intravenous infusion
 Drug: fluconazole
intravenous infusion
Other Name: Diflucan

Drug: liposomal amphotericin B
intravenous infusion
Other Name: AmBisome

Drug: caspofungin
intravenous infusion
Other Name: Cancidas


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). [ Time Frame: up to 21 days ]

Secondary Outcome Measures :
  1. Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB [ Time Frame: 3 months ]
  2. 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 ]
  3. Time to 'proven' or 'probable' IFD [ Time Frame: up to 3 months ]
  4. Fungal free survival at the End of Study and at the end of Long-term Follow-up [ Time Frame: 3 months & 6 months ]
  5. Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [ Time Frame: up to 21 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058174


  Show 36 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Link to results on Astellas Clinical Study Results website  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01058174     History of Changes
Other Study ID Numbers: 9463-EC-0001
2008-005214-49 ( EudraCT Number )
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
URL: http://

Keywords provided by Astellas Pharma Inc:
Prophylaxis
Liver transplantation
Invasive Fungal Infection
 Micafungin
Prevention
Mycoses

Additional relevant MeSH terms:
Mycoses
Fluconazole
Amphotericin B
Liposomal amphotericin B
Micafungin
Echinocandins
Caspofungin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents