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

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ClinicalTrials.gov Identifier: NCT01303549
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : May 30, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA

Tracking Information
First Submitted Date  ICMJE February 16, 2011
First Posted Date  ICMJE February 24, 2011
Last Update Posted Date May 30, 2014
Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2012)
  • Renal impairment/renal function deterioration [ Time Frame: 14 days ]
    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 ]
    Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • Renal impairment/renal function deterioration [ Time Frame: 14 days ]
    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 ]
    Compare the development infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal anfotericin B
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • Treatment discontinuation [ Time Frame: 14 days ]
    Compare the proportion of patiens who discontinue antifungal profilaxis in both arms
  • Hepatic toxicity [ Time Frame: 14 days ]
    Compare the emergence of hepatic toxicity in both arms
  • Invasive fungal infection [ Time Frame: Week 12 and week 24 ]
    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 ]
    Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
Official Title  ICMJE Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Disease
  • Fungal Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2014)
61
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2011)
94
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303549
Other Study ID Numbers  ICMJE GESITRA 0110
2011-000804-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundacion SEIMC-GESIDA
Study Sponsor  ICMJE Fundacion SEIMC-GESIDA
Collaborators  ICMJE Pfizer
Investigators  ICMJE
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
PRS Account Fundacion SEIMC-GESIDA
Verification Date September 2013

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