Acute Renal FailurePhase 2NCT00892359
Anidulafungin During Continuous Venovenous Hemofiltration (CVVHF)
A Phase 2 study testing Anidulafungin in people with Acute Renal Failure and Infection, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this trial is to study the pharmacokinetics of anidulafungin during continuous venovenous hemofiltration. Background: Anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Acute Renal Failure, Infection
- What is being tested?
- Anidulafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2009to Apr 2010
- Phase
- Phase 2
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 to 70 years
- Suspected or proven infection requiring parenteral antifungal therapy.
- Continuous venovenous hemofiltration because of an acute renal failure.
Who cannot join
- Known history of hypersensitivity to echinocandins.
- An expected survival of less than three days.
- Known alcohol dependency, epilepsy, pregnancy or liver failure.
- Neutropenic patients
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Judith M Leitner, M.D., +43140400, judith.leitner@meduniwien.ac.at
Judith M Leitner, M.D.
About this study
Official title: The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration
The purpose of this trial is to study the pharmacokinetics of anidulafungin during continuous venovenous hemofiltration.
Background: Anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of this class of antifungal agents are known to inhibit the synthesis of glucan polymers in fungal cell walls. The spectrum of activity of anidulafungin includes Candida (all species, including strains resistant to fluconazole), Aspergillus, and Pneumocystis.
Read more
In intensive care patients continuous venovenous haemodiafiltration (CVVHF) is a well-established extracorporal renal replacement therapy with a high clearance rate.
Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHF are rare. No data about anidulafungin in CVVHF are available although intensive care patients are perfect candidates for anidulafungin treatment due to their high risk profile for systemic fungal infections.
Study objective: The study is conducted to investigate the pharmacokinetics of anidulafungin during CVVHF in critically ill patients.
Study design: open, 1 arm
Study population: 10 critically ill adult patients administered to the ICU with acute renal failure and suspected or proven fungal infection.
Treatment/Dosage/Route: On the first day 200 mg of anidulafungin will be administered intravenously over 3 hours (loading dose). The following days 100 mg of anidulafungin will be administered intravenously over 1.5 hours.
Main outcome variables: The following pharmacokinetic parameters will be determined: area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.
Methods: High pressure liquid chromatography (HPLC) will be used to determine anidulafungin concentrations.
- Conditions
- Acute Renal Failure, Infection
- Being tested
- Anidulafungin
- Keywords
- pharmacokinetics, renal replacement therapy, hemofiltration, anidulafungin
- Medical subject headings
- Acute Kidney Injury, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnidulafunginDrug
treatment for 3 days, 200 mg intravenously on the first treatment day and 100 mg on the 2 following treatment days each.
| Study group | Role | What they receive |
|---|---|---|
| Anidulafungin | Experimental | Not described Receives: Drug: Anidulafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892359
- Sponsor's protocol ID
- 1.1 - Leitner
- Status last verified
- Apr 2009
- First submitted
- 30 Apr 2009
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Anidulafungin During Continuous Venovenous Hemofiltration
- ClinicalTrials.gov ID
- NCT00892359
- Acronym / sponsor ID
- 1.1 - Leitner
- Conditions
- Acute Renal Failure, Infection
- Keywords
- pharmacokinetics, renal replacement therapy, hemofiltration, anidulafungin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (estimated)
- First posted
- 4 May 2009 (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 purpose of this trial is to study the pharmacokinetics of anidulafungin during continuous venovenous hemofiltration.
Background: Anidulafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of this class of antifungal agents are known to inhibit the synthesis of glucan polymers in fungal cell walls. The spectrum of activity of anidulafungin includes Candida (all species, including strains resistant to fluconazole), Aspergillus, and Pneumocystis.
In intensive care patients continuous venovenous haemodiafiltration (CVVHF) is a well-established extracorporal renal replacement therapy with a high clearance rate.
Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHF are rare. No data about anidulafungin in CVVHF are available although intensive care patients are perfect candidates for anidulafungin treatment due to their high risk profile for systemic fungal infections.
Study objective: The study is conducted to investigate the pharmacokinetics of anidulafungin during CVVHF in critically ill patients.
Study design: open, 1 arm
Study population: 10 critically ill adult patients administered to the ICU with acute renal failure and suspected or proven fungal infection.
Treatment/Dosage/Route: On the first day 200 mg of anidulafungin will be administered intravenously over 3 hours (loading dose). The following days 100 mg of anidulafungin will be administered intravenously over 1.5 hours.
Main outcome variables: The following pharmacokinetic parameters will be determined: area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.
Methods: High pressure liquid chromatography (HPLC) will be used to determine anidulafungin concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anidulafungin | Experimental | Drug: Anidulafungin |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 19 to 70 years
- Suspected or proven infection requiring parenteral antifungal therapy.
- Continuous venovenous hemofiltration because of an acute renal failure.
Key exclusion criteria (4 listed)
- Known history of hypersensitivity to echinocandins.
- An expected survival of less than three days.
- Known alcohol dependency, epilepsy, pregnancy or liver failure.
- Neutropenic patients
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 |
|---|---|---|
| Anidulafungintreatment for 3 days, 200 mg intravenously on the first treatment day and 100 mg on the 2 following treatment days each. | Drug | Anidulafungin |
Primary outcome
Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anidulafungin in people with Acute Renal Failure and Infection, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith M Leitner, M.D. (+43140400 ext. 4440, judith.leitner@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anidulafungin area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction. (time frame: 1 year). 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 4 May 2009.