Renal FailureNCT00256100
Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.
A study testing Fondaparinux Sodium in people with Renal Failure, run by Melbourne Health at 1 site in Australia.
Trial summary
The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Fondaparinux Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2004to Dec 2007
- Phase
- Interventional
- 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
- Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours.
- Patients who require continuous renal replacement therapy.
- Patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. .
- -
Who cannot join
- Patients aged less than 18 years of age.
- Patients who are pregnant
- Patients with a contraindication to anticoagulation for pre existing bleeding diathesis
- Patients or next of kin who do not consent to study inclusion. -
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Royal Melbourne Hospital Intensive Care Unit Grattan Street
Parkville, Victoria, 3050
About this study
Official title: Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure.
The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.
Read the detailed description
The study hypothesis is that when used as an anticoagulant in haemofiltration, fondaparinux prolongs the filter life when compared to enoxaparin.
Fondaparinux is the first compound of a new class of synthetic oligosaccharides with antithrombotic effects. It represents the active portion of the natural heparin molecule.
The null hypothesis is that there is no difference in filter life when using fondaparinux or enoxaparin as anticoagulation for haemofiltration.
- Conditions
- Renal Failure
- Being tested
- Fondaparinux Sodium
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fondaparinux SodiumDrug
Also called Arixtra
The active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| One | Active comparator | Enoxaparin Sodium (Clexane ) is to be used in the control arm of the study Receives: Drug: Fondaparinux Sodium |
| Two | Active comparator | Fondaparinux will be used as the anticoagulant in the sencond arm of the study Receives: Drug: Fondaparinux Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study will evaluate the duration of filter patency using fondaparinux as an anticoagulant in haemofiltration and compare this to the current standard haemofilter anticoagulant, enoxaparin.
Measured: Duration of the haemofilter life
Secondary outcomes (1)
To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.
Measured: Until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJun 2004
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Teh Priincipal investigator responsible for the trial no longer employed at the study site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Investigators
- John F Cade, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256100
- Sponsor's protocol ID
- 2004.066
- Status last verified
- Apr 2015
- First submitted
- 17 Nov 2005
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure.
- ClinicalTrials.gov ID
- NCT00256100
- Acronym / sponsor ID
- 2004.066
- Conditions
- Renal Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Teh Priincipal investigator responsible for the trial no longer employed at the study site.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 Nov 2005 (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 project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.
Detailed description
The study hypothesis is that when used as an anticoagulant in haemofiltration, fondaparinux prolongs the filter life when compared to enoxaparin.
Fondaparinux is the first compound of a new class of synthetic oligosaccharides with antithrombotic effects. It represents the active portion of the natural heparin molecule.
The null hypothesis is that there is no difference in filter life when using fondaparinux or enoxaparin as anticoagulation for haemofiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One | Active comparator | Drug: Fondaparinux SodiumEnoxaparin Sodium (Clexane ) is to be used in the control arm of the study |
| Two | Active comparator | Drug: Fondaparinux SodiumFondaparinux will be used as the anticoagulant in the sencond arm of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours.
- Patients who require continuous renal replacement therapy.
- Patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. .
- -
Key exclusion criteria (4 listed)
- Patients aged less than 18 years of age.
- Patients who are pregnant
- Patients with a contraindication to anticoagulation for pre existing bleeding diathesis
- Patients or next of kin who do not consent to study inclusion. -
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 |
|---|---|---|
| Fondaparinux SodiumAlso: ArixtraThe active group of the study will be given fondaparinux 10mg/24 hours for haemofiltration anticoagulation | Drug | One, Two |
Primary outcome
The study will evaluate the duration of filter patency using fondaparinux as an anticoagulant in haemofiltration and compare this to the current standard haemofilter anticoagulant, enoxaparin.
Time frame: Duration of the haemofilter life
1 secondary outcome
To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.
Time frame: Until hospital discharge
Results and safety
The study was stopped early (reason given: Teh Priincipal investigator responsible for the trial no longer employed at the study site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
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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.
John F Cade principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fondaparinux Sodium in people with Renal Failure, run by Melbourne Health at 1 site in Australia.
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 4 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: stopped early, as of the sponsor's last update on 12 Apr 2017. 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 Australia. 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.
Are results available for this study?
The study was stopped early (reason given: Teh Priincipal investigator responsible for the trial no longer employed at the study site.). Results are not available in the source record.
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?
The study will evaluate the duration of filter patency using fondaparinux as an anticoagulant in haemofiltration and compare this to the current standard haemofilter anticoagulant, enoxaparin. (time frame: Duration of the haemofilter life). 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 12 Apr 2017.