Liver Transplant European Study Into the Prevention of Fungal Infection (TENPIN)
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ClinicalTrials.gov Identifier: NCT01058174 |
Recruitment Status
:
Completed
First Posted
: January 28, 2010
Last Update Posted
: November 22, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Transplantation Mycoses | Drug: micafungin Drug: fluconazole Drug: liposomal amphotericin B Drug: caspofungin | Phase 3 |
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 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 |
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
|
- 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). [ Time Frame: up to 21 days ]
- Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB [ Time Frame: 3 months ]
- 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 ]
- Time to 'proven' or 'probable' IFD [ Time Frame: up to 3 months ]
- Fungal free survival at the End of Study and at the end of Long-term Follow-up [ Time Frame: 3 months & 6 months ]
- Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [ Time Frame: up to 21 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | Use Central Contact | Astellas Pharma Europe Ltd. |
Additional Information:
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 |