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Liver Transplant European Study Into the Prevention of Fungal Infection (TENPIN)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01058174
First received: January 26, 2010
Last updated: June 5, 2015
Last verified: June 2015
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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 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 ]
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 ]
- 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 ]
| 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 (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01058174
Show 36 Study 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:
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 ) |
| Study First Received: | January 26, 2010 |
| Last Updated: | June 5, 2015 |
Keywords provided by Astellas Pharma Inc:
|
Liver transplantation Prophylaxis Prevention |
Mycoses Invasive Fungal Infection Micafungin |
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 |
ClinicalTrials.gov processed this record on July 27, 2017