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

Randomized, Open Label, Non-inferiority Study of Micafungin Versus Fluconazole for the Korean Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

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.

Study Overview

• Status: Unknown
• Conditions: Liver Transplant Recipient
• Intervention / Treatment: Drug: micafungin; Drug: Fluconazole

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.

• Study Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Giwon Song, Professor; Phone Number: +82-10-8794-8701; Email: drsong71@hotmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center
    • Contact: Giwon Song, Professor; Phone Number: +82-10-8794-8701; Email: drsong71@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: micafungin; micafungin sodium IV (Mycamine®)	Drug: micafungin; Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg); Other Names: Mycamine
Active Comparator: Fluconazole; Fluconazole IV (use same brand in each hospital)	Drug: Fluconazole; Fluconazole 100~200mg/day, IV care until oral medication becomes possible

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
no events of proven/probable IFD	no events of proven/probable IFD at end of prophylaxis visit and end of study visit	6 months
ime to proven/probable IFD	Time to proven/probable IFD	6 months
fungal-free survival	fungal-free survival et end of study/and long-term follow-up visit	6 months
incidence of superficial mycosis infection and colonization	incidence of superficial mycosis infection and colonization at the end of prophylaxis compare to baseline	6 months
saftey by variables	saftey by variables of viatl sign/physical examination/laboratory test	6 months
cases of adverse events	cases of adverse events	6 months

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Giwon Song, Professor, Asan Medical Center; Principal Investigator: SUNG-GYU LEE, Professor, Asan Medical Center; Principal Investigator: Namjoon Lee, Professor, Seoul National University; Principal Investigator: Jaewon Joh, Professor, Samsung Medical Center; Principal Investigator: Dong-Lak Choi, Professor, Daegu Catholic University Medical Center; Principal Investigator: Myung Soo Kim, professor, Severance Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 27, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 27, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Liver transplant; Living donor; antifungal prevention
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Micafungin; Fluconazole
• Other Study ID Numbers: MYC-LT-01