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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: 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 |
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.
For general information, see Learn About Clinical Studies.
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 September 25, 2017