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Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients (KOPIN)

Primary Purpose

Liver Transplant Recipient

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
micafungin
Fluconazole
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplant Recipient focused on measuring Living donor, Liver transplant, antifungal prevention

Eligibility Criteria

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

Inclusion Criteria:

  • Age > 20 years.
  • Undergoing Living Donor Liver Transplantation(LDLT)

Exclusion Criteria:

  • Any systemic antifungal therapy (excluding fluconazole or SDD 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.
  • Reimplantation or orthotopic transplantation patient.

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

micafungin

Fluconazole

Arm Description

micafungin sodium IV (Mycamine®)

Fluconazole IV (use same brand in each hospital)

Outcomes

Primary Outcome Measures

Prevention of invasive fungal disease
To demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation. 'Clinical success' at the End of Prophylaxis as assessed by the investigator. Absence of a 'proven' or 'probable' IFD AND No initiation of antifungal treatment (additional antifungal medication or increase in the dose of the study drug due to lack of efficacy)

Secondary Outcome Measures

no events of proven/probable IFD
no events of proven/probable IFD at end of prophylaxis visit and end of study visit
ime to proven/probable IFD
Time to proven/probable IFD
fungal-free survival
fungal-free survival et end of study/and long-term follow-up visit
incidence of superficial mycosis infection and colonization
incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline
saftey by variables
saftey by variables of viatl sign/physical examination/laboratory test
cases of adverse events
cases of adverse events

Full Information

First Posted
October 18, 2013
Last Updated
October 27, 2013
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01974375
Brief Title
Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
Acronym
KOPIN
Official Title
Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation.
Detailed Description
This is Randomized, Open label, Non-inferiority Study of Micafungin versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients After transplant subjects will be randomized to one of the following treatment arms: Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg) Fluconazole 100~200mg/day, IV care until oral medication becomes possible Stratification according to centers. Antifungal prophylaxis will be administered once daily for a period of 21 days, or until hospital discharge, whichever occurs first. This is an open label study; Study center personnel will not be blinded to treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant Recipient
Keywords
Living donor, Liver transplant, antifungal prevention

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
micafungin
Arm Type
Experimental
Arm Description
micafungin sodium IV (Mycamine®)
Arm Title
Fluconazole
Arm Type
Active Comparator
Arm Description
Fluconazole IV (use same brand in each hospital)
Intervention Type
Drug
Intervention Name(s)
micafungin
Other Intervention Name(s)
Mycamine
Intervention Description
Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg)
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
Fluconazole 100~200mg/day, IV care until oral medication becomes possible
Primary Outcome Measure Information:
Title
Prevention of invasive fungal disease
Description
To demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus fluconzeole for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, undergoing living-donor liver transplantation. 'Clinical success' at the End of Prophylaxis as assessed by the investigator. Absence of a 'proven' or 'probable' IFD AND No initiation of antifungal treatment (additional antifungal medication or increase in the dose of the study drug due to lack of efficacy)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
no events of proven/probable IFD
Description
no events of proven/probable IFD at end of prophylaxis visit and end of study visit
Time Frame
6 months
Title
ime to proven/probable IFD
Description
Time to proven/probable IFD
Time Frame
6 months
Title
fungal-free survival
Description
fungal-free survival et end of study/and long-term follow-up visit
Time Frame
6 months
Title
incidence of superficial mycosis infection and colonization
Description
incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline
Time Frame
6 months
Title
saftey by variables
Description
saftey by variables of viatl sign/physical examination/laboratory test
Time Frame
6 months
Title
cases of adverse events
Description
cases of adverse events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 20 years. Undergoing Living Donor Liver Transplantation(LDLT) Exclusion Criteria: Any systemic antifungal therapy (excluding fluconazole or SDD 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. Reimplantation or orthotopic transplantation patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giwon Song, Professor
Phone
+82-10-8794-8701
Email
drsong71@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SUNG-GYU LEE, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giwon Song, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Namjoon Lee, Professor
Organizational Affiliation
Seoul National University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaewon Joh, Professor
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong-Lak Choi, Professor
Organizational Affiliation
Daegu Catholic University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myung Soo Kim, professor
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giwon Song, Professor
Phone
+82-10-8794-8701
Email
drsong71@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31066013
Citation
Kang WH, Song GW, Lee SG, Suh KS, Lee KW, Yi NJ, Joh JW, Kwon CHD, Kim JM, Choi DL, Kim JD, Kim MS. A Multicenter, Randomized, Open-Label Study to Compare Micafungin with Fluconazole in the Prophylaxis of Invasive Fungal Infections in Living-Donor Liver Transplant Recipients. J Gastrointest Surg. 2020 Apr;24(4):832-840. doi: 10.1007/s11605-019-04241-w. Epub 2019 May 7.
Results Reference
derived

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Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

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