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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01058174
First received: January 26, 2010
Last updated: November 26, 2013
Last verified: October 2012
  Purpose

Prevention of invasive fungal infection in high risk patients following liver transplant.


Condition Intervention Phase
Liver Transplantation
Mycoses
Drug: micafungin
Drug: fluconazole
Drug: liposomal amphotericin B
Drug: caspofungin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to 'proven' or 'probable' IFD [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Fungal free survival at the End of Study and at the end of Long-term Follow-up [ Time Frame: 3 months & 6 months ] [ Designated as safety issue: No ]
  • Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: December 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: micafungin Drug: micafungin
intravenous infusion
Other Name: Mycamine
Active Comparator: standard care Drug: fluconazole
intravenous infusion
Other Name: Diflucan
Drug: liposomal amphotericin B
intravenous infusion
Other Name: AmBisome
Drug: caspofungin
intravenous infusion
Other Name: Cancidas

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058174

  Show 36 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01058174     History of Changes
Other Study ID Numbers: 9463-EC-0001, 2008-005214-49
Study First Received: January 26, 2010
Last Updated: November 26, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ethics Committee
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation
Saudi Arabia: Ministry of Health
Romania: National Medicines Agency
Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Mycoses
Amphotericin B
Liposomal amphotericin B
Fluconazole
Caspofungin
Micafungin
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014