Liver DiseasePhase 4AVALTRANCT01303549
Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
A Phase 4 study testing Anidulafungin and Liposomal amphotericin B in people with Liver Disease and Fungal Infection, run by Fundacion SEIMC-GESIDA at 12 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease, Fungal Infection
- What is being tested?
- Anidulafungin and Liposomal amphotericin B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 12 sitesSpain
- Study dates
- Nov 2011to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Complexo Hospitalario de A Coruña
A Coruña
Hospital Clinic i Provincial
Barcelona
Hospital de Bellvitge
Barcelona
Hospital Vall d'Hebrón
Barcelona
Hospital de Cruces
Bilbao
Hospital Reina Sofia
Córdoba, Córdoba
Hospital Doce de Octubre
Madrid
Hospital Gregorio Marañón
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Carlos Haya
Málaga
Hospital Central de Asturias
Oviedo
Hospital Marqués de Valdecilla
Santander
About this study
Official title: 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.
- Conditions
- Liver Disease, Fungal Infection
- Being tested
- Anidulafungin, Liposomal amphotericin B
- Keywords
- Liver transplantation, Hepatic transplant, Antifungal prophylaxis, Anidulafungin, Liposomal Amphotericin B
- Medical subject headings
- Liver Diseases, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnidulafunginDrug
Also called Ecalta
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.
Liposomal amphotericin BDrug
Also called AmBisome
Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Anidulafungin | Experimental | Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day. Receives: Drug: Anidulafungin |
| Liposomal Amphotericin B | Active comparator | Liposomal amphotericin B once a day: 3 mg/kg/day Receives: Drug: Liposomal amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 14 days
Secondary outcomes (4)
Treatment discontinuation
Compare the proportion of patiens who discontinue antifungal profilaxis in both arms
Measured: 14 days
Hepatic toxicity
Compare the emergence of hepatic toxicity in both arms
Measured: 14 days
Invasive fungal infection
Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms
Measured: Week 12 and week 24
Mortality
Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation
Measured: 24 weeks post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Carlos Cervera, MD, Study director, Hospital Clinic i ProvincialAsuncion Moreno, MD, Principal investigator, Hospital Clinic i ProvincialCarmen Fariñas, MD, Principal investigator, Hospital Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303549
- Sponsor's protocol ID
- GESITRA 0110
- Other IDs
- 2011-000804-17
- Acronym
- AVALTRA
- Status last verified
- Sep 2013
- First submitted
- 16 Feb 2011
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients
- ClinicalTrials.gov ID
- NCT01303549
- Acronym / sponsor ID
- AVALTRA / GESITRA 0110
- Conditions
- Liver Disease, Fungal Infection
- Keywords
- Liver transplantation, Hepatic transplant, Antifungal prophylaxis, Anidulafungin, Liposomal Amphotericin B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anidulafungin | Experimental | Drug: AnidulafunginAnidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day. |
| Liposomal Amphotericin B | Active comparator | Drug: Liposomal amphotericin BLiposomal amphotericin B once a day: 3 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
- Re-transplant due to severe dysfunction of a previous hepatic graft
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnidulafunginAlso: EcaltaAnidulafungin 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. | Drug | Anidulafungin |
| Liposomal amphotericin BAlso: AmBisomeLiposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes. | Drug | Liposomal Amphotericin B |
Primary outcome
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
4 secondary outcomes
Treatment discontinuation
Time frame: 14 days
Hepatic toxicity
Time frame: 14 days
Invasive fungal infection
Time frame: Week 12 and week 24
Mortality
Time frame: 24 weeks post transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Cervera, MD study director
Hospital Clinic i Provincial
Asuncion Moreno, MD principal investigator
Hospital Clinic i Provincial
Carmen Fariñas, MD principal investigator
Hospital Marqués de Valdecilla
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anidulafungin and Liposomal amphotericin B in people with Liver Disease and Fungal Infection, run by Fundacion SEIMC-GESIDA at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal impairment/renal function deterioration (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.