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Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients (AVALTRA)

Primary Purpose

Liver Disease, Fungal Infection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Anidulafungin
Liposomal amphotericin B
Sponsored by
Fundacion SEIMC-GESIDA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Disease focused on measuring Liver transplantation, Hepatic transplant, Antifungal prophylaxis, Anidulafungin, Liposomal Amphotericin B

Eligibility Criteria

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

Inclusion Criteria:

  • At least 18 years old
  • Signature of ICF
  • Negative pregnancy test (women of child bearing potential)
  • Patients who comply with at least one of the following (A or B):

A: One of the following criteria (major criteria):

  • Re-transplant due to severe dysfunction of a previous hepatic graft
  • Requirement of any renal substitutive therapy, including dialysis or hemofiltration
  • Fulminant hepatitis requiring hepatic transplant

B: Two of the following criteria (minor criteria):

  • Post-transplant renal impairment (defined as CrCl< 50 mL/min) 30 days after transplantation
  • Intra surgery blood transfusion of at least 40 units
  • Choledochal jejunectomy
  • 2 or more Candida sp cultures (nasal, pharynx, rectal) from 48 hours pre- to 48 hours post-hepatic transplant
  • Post transplant re-intervention (laparotomy)

Exclusion Criteria:

  • Hypersensibility to amphotericin B or candin
  • Patients who have received any other antifungal (excluding fluconazole or oral nystatin for a maximum of 7 days)
  • Documented or suspected fungal infection
  • Pregnant women of women who do not accept to us a valid anticonceptive method
  • Any other disease or medical condition that makes the patient not adequate to participate in the trial

Sites / Locations

  • Hospital Clinic i Provincial
  • Hospital de Bellvitge
  • Hospital Vall d'Hebrón
  • Hospital de Cruces
  • Hospital Reina Sofia
  • Complexo Hospitalario de A Coruña
  • Hospital Doce de Octubre
  • Hospital Gregorio Marañón
  • Hospital Ramón y Cajal
  • Hospital Carlos Haya
  • Hospital Central de Asturias
  • Hospital Marqués de Valdecilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anidulafungin

Liposomal Amphotericin B

Arm Description

Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day.

Liposomal amphotericin B once a day: 3 mg/kg/day

Outcomes

Primary Outcome Measures

Renal impairment/renal function deterioration
Compare the development of renal imparment or deterioration of baseline renal function in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
Number of infusion related adverse events
Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B

Secondary Outcome Measures

Treatment discontinuation
Compare the proportion of patiens who discontinue antifungal profilaxis in both arms
Hepatic toxicity
Compare the emergence of hepatic toxicity in both arms
Invasive fungal infection
Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms
Mortality
Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation

Full Information

First Posted
February 16, 2011
Last Updated
May 29, 2014
Sponsor
Fundacion SEIMC-GESIDA
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01303549
Brief Title
Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
Acronym
AVALTRA
Official Title
Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion SEIMC-GESIDA
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B (3 mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease, Fungal Infection
Keywords
Liver transplantation, Hepatic transplant, Antifungal prophylaxis, Anidulafungin, Liposomal Amphotericin B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anidulafungin
Arm Type
Experimental
Arm Description
Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day.
Arm Title
Liposomal Amphotericin B
Arm Type
Active Comparator
Arm Description
Liposomal amphotericin B once a day: 3 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Anidulafungin
Other Intervention Name(s)
Ecalta
Intervention Description
Anidulafungin once a day for 14 days: initial dose 200 mg/day IV administered in 180 minutes. Following doses 100 mg/day IV administered in 90 minutes.
Intervention Type
Drug
Intervention Name(s)
Liposomal amphotericin B
Other Intervention Name(s)
AmBisome
Intervention Description
Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.
Primary Outcome Measure Information:
Title
Renal impairment/renal function deterioration
Description
Compare the development of renal imparment or deterioration of baseline renal function in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
Time Frame
14 days
Title
Number of infusion related adverse events
Description
Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Treatment discontinuation
Description
Compare the proportion of patiens who discontinue antifungal profilaxis in both arms
Time Frame
14 days
Title
Hepatic toxicity
Description
Compare the emergence of hepatic toxicity in both arms
Time Frame
14 days
Title
Invasive fungal infection
Description
Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms
Time Frame
Week 12 and week 24
Title
Mortality
Description
Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation
Time Frame
24 weeks post transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years old Signature of ICF Negative pregnancy test (women of child bearing potential) Patients who comply with at least one of the following (A or B): A: One of the following criteria (major criteria): Re-transplant due to severe dysfunction of a previous hepatic graft Requirement of any renal substitutive therapy, including dialysis or hemofiltration Fulminant hepatitis requiring hepatic transplant B: Two of the following criteria (minor criteria): Post-transplant renal impairment (defined as CrCl< 50 mL/min) 30 days after transplantation Intra surgery blood transfusion of at least 40 units Choledochal jejunectomy 2 or more Candida sp cultures (nasal, pharynx, rectal) from 48 hours pre- to 48 hours post-hepatic transplant Post transplant re-intervention (laparotomy) Exclusion Criteria: Hypersensibility to amphotericin B or candin Patients who have received any other antifungal (excluding fluconazole or oral nystatin for a maximum of 7 days) Documented or suspected fungal infection Pregnant women of women who do not accept to us a valid anticonceptive method Any other disease or medical condition that makes the patient not adequate to participate in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Cervera, MD
Organizational Affiliation
Hospital Clinic i Provincial
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Asuncion Moreno, MD
Organizational Affiliation
Hospital Clinic i Provincial
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmen Fariñas, MD
Organizational Affiliation
Hospital Marqués de Valdecilla
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic i Provincial
City
Barcelona
Country
Spain
Facility Name
Hospital de Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital de Cruces
City
Bilbao
Country
Spain
Facility Name
Hospital Reina Sofia
City
Córdoba
Country
Spain
Facility Name
Complexo Hospitalario de A Coruña
City
La Coruña
Country
Spain
Facility Name
Hospital Doce de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Carlos Haya
City
Malaga
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital Marqués de Valdecilla
City
Santander
Country
Spain

12. IPD Sharing Statement

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Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

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