NCT01303549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 30, 2014

Status Verified

September 1, 2013

Enrollment Period

2.5 years

First QC Date

February 16, 2011

Last Update Submit

May 29, 2014

Conditions

Liver DiseaseFungal Infection

Keywords

Liver transplantationHepatic transplantAntifungal prophylaxisAnidulafunginLiposomal Amphotericin B

Outcome Measures

Primary Outcomes (2)

  • 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

    14 days

  • 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

    14 days

Secondary Outcomes (4)

  • Treatment discontinuation

    14 days

  • Hepatic toxicity

    14 days

  • Invasive fungal infection

    Week 12 and week 24

  • Mortality

    24 weeks post transplantation

Study Arms (2)

Anidulafungin

EXPERIMENTAL

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

Drug: Anidulafungin

Liposomal Amphotericin B

ACTIVE COMPARATOR

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

Drug: Liposomal amphotericin B

Interventions

AnidulafunginDRUG

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.

Also known as: Ecalta
Anidulafungin
Liposomal amphotericin BDRUG

Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.

Also known as: AmBisome
Liposomal Amphotericin B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • or more Candida sp cultures (nasal, pharynx, rectal) from 48 hours pre- to 48 hours post-hepatic transplant
  • Post transplant re-intervention (laparotomy)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital Reina Sofia

Córdoba, Córdoba, Spain

Location

Complexo Hospitalario de A Coruña

A Coruña, Spain

Location

Hospital Clinic i Provincial

Barcelona, Spain

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital Vall d'Hebrón

Barcelona, Spain

Location

Hospital de Cruces

Bilbao, Spain

Location

Hospital Doce de Octubre

Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

Hospital Central de Asturias

Oviedo, Spain

Location

Hospital Marqués de Valdecilla

Santander, Spain

Location

MeSH Terms

Conditions

Liver DiseasesMycoses

Interventions

Anidulafunginliposomal amphotericin B

Condition Hierarchy (Ancestors)

Digestive System DiseasesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

EchinocandinsPeptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Carlos Cervera, MD

    Hospital Clinic i Provincial

    STUDY DIRECTOR

  • Asuncion Moreno, MD

    Hospital Clinic i Provincial

    PRINCIPAL INVESTIGATOR

  • Carmen Fariñas, MD

    Hospital Marqués de Valdecilla

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 24, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 30, 2014

Record last verified: 2013-09

Locations

ES(12)