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

This study is currently recruiting participants.
Verified September 2013 by Fundacion SEIMC-GESIDA
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01303549
First received: February 16, 2011
Last updated: September 11, 2013
Last verified: September 2013

February 16, 2011
September 11, 2013
November 2011
December 2013   (final data collection date for primary outcome measure)
  • Renal impairment/renal function deterioration [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
  • Renal impairment/renal function deterioration [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Compare the development of renal imparment or deterioration of baseline renal funcion in hepatic transplat recipients who receive anidulafungin or liposomal anfotericin B
  • Number of infusion related adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Compare the development infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal anfotericin B
Complete list of historical versions of study NCT01303549 on ClinicalTrials.gov Archive Site
  • Treatment discontinuation [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Compare the proportion of patiens who discontinue antifungal profilaxis in both arms
  • Hepatic toxicity [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Compare the emergence of hepatic toxicity in both arms
  • Invasive fungal infection [ Time Frame: Week 12 and week 24 ] [ Designated as safety issue: Yes ]
    Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms
  • Mortality [ Time Frame: 24 weeks post transplantation ] [ Designated as safety issue: Yes ]
    Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation
Same as current
Not Provided
Not Provided
 
Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Disease
  • Fungal Infection
  • Drug: Anidulafungin
    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.
    Other Name: Ecalta
  • Drug: Liposomal amphotericin B
    Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.
    Other Name: AmBisome
  • Experimental: Anidulafungin
    Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day.
    Intervention: Drug: Anidulafungin
  • Active Comparator: Liposomal Amphotericin B
    Liposomal amphotericin B once a day: 3 mg/kg/day
    Intervention: Drug: Liposomal amphotericin B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
94
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Miriam Ramírez, PhD +34915568025 mramirez@f-sg.org
Contact: Herminia Esteban, BSc +34915568025 hesteban@f-sg.org
Spain
 
NCT01303549
GESITRA 0110, 2011-000804-17
Yes
Fundacion SEIMC-GESIDA
Fundacion SEIMC-GESIDA
Pfizer
Study Director: Carlos Cervera, MD Hospital Clinic i Provincial
Principal Investigator: Asuncion Moreno, MD Hospital Clinic i Provincial
Principal Investigator: Carmen Fariñas, MD Hospital Marqués de Valdecilla
Fundacion SEIMC-GESIDA
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP