Medical PatientsPhase 4NCT00927602
Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency
A Phase 4 study testing fondaparinux in people with Medical Patients and Renal Insufficiency, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Medical Patients, Renal Insufficiency
- What is being tested?
- fondaparinux
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Mar 2012
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60 years
- Acute medical disease requiring thromboprophylaxis according to international guidelines
- Anticipated immobilization of at least 4 days
- Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula
- Written informed consent
Who cannot join
- Active bleeding or bleeding in the previous 3 months
- Known bleeding diathesis
- Platelet count < 100.000
- Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists
- Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours
- Life expectancy < 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency
Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.
- Conditions
- Medical Patients, Renal Insufficiency
- Being tested
- fondaparinux
- Keywords
- renal failure, medical patient, venous thromboembolism, prophylaxis, fondaparinux
- Medical subject headings
- Renal Insufficiency, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinuxDrug
Also called Arixtra
once daily sc injection, 1,5 mg, max 14 days
| Study group | Role | What they receive |
|---|---|---|
| fondaparinux | Experimental | Not described Receives: Drug: fondaparinux |
What is being measured
The primary outcome is the main question the study is designed to answer.
major bleeding
Measured: up to 48 hours from last injection
Secondary outcomes (1)
symptomatic venous thromboembolism
Measured: last treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2011
- Study completionMar 2012
Why it stopped: study was stopped after enrolment of about 200 patients for slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medical PatientsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Ageno, Università degli Studi dell'Insubria
- Investigators
- Walter Ageno, MD, Study chair, Università degli Studi dell'InsubriaFrancesco Dentali, MD, Study director, Università degli Studi dell'InsubriaAlessandro Squizzato, MD, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927602
- Sponsor's protocol ID
- 2008-005234-79
- Other IDs
- 2008
- Status last verified
- Apr 2012
- First submitted
- 24 Jun 2009
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.
PubMed 16439370Lim W, Dentali F, Eikelboom JW, Crowther MA. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med. 2006 May 2;144(9):673-84. doi: 10.7326/0003-4819-144-9-200605020-00011.
PubMed 16670137Ageno W, Riva N, Noris P, Di Nisio M, La Regina M, Arioli D, Ria L, Monzani V, Cuppini S, Lupia E, Giorgi Pierfranceschi M, Dentali F; FONDAIR study group. Safety and efficacy of low-dose fondaparinux (1.5 mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: the FONDAIR study. J Thromb Haemost. 2012 Nov;10(11):2291-7. doi: 10.1111/j.1538-7836.2012.04908.x.
PubMed 22925036
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency
- ClinicalTrials.gov ID
- NCT00927602
- Acronym / sponsor ID
- 2008-005234-79
- Conditions
- Medical Patients, Renal Insufficiency
- Keywords
- renal failure, medical patient, venous thromboembolism, prophylaxis, fondaparinux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study was stopped after enrolment of about 200 patients for slow recruitment
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Jun 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.
Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fondaparinux | Experimental | Drug: fondaparinux |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 60 years
- Acute medical disease requiring thromboprophylaxis according to international guidelines
- Anticipated immobilization of at least 4 days
- Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula
- Written informed consent
Key exclusion criteria (6 listed)
- Active bleeding or bleeding in the previous 3 months
- Known bleeding diathesis
- Platelet count < 100.000
- Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists
- Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours
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 |
|---|---|---|
| fondaparinuxAlso: Arixtraonce daily sc injection, 1,5 mg, max 14 days | Drug | fondaparinux |
Primary outcome
major bleeding
Time frame: up to 48 hours from last injection
1 secondary outcome
symptomatic venous thromboembolism
Time frame: last treatment dose
Results and safety
The study was stopped early (reason given: study was stopped after enrolment of about 200 patients for slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
- Background: PubMed 16439370Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.
- Background: PubMed 16670137Lim W, Dentali F, Eikelboom JW, Crowther MA. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med. 2006 May 2;144(9):673-84. doi: 10.7326/0003-4819-144-9-200605020-00011.
- Derived from this study: PubMed 22925036Ageno W, Riva N, Noris P, Di Nisio M, La Regina M, Arioli D, Ria L, Monzani V, Cuppini S, Lupia E, Giorgi Pierfranceschi M, Dentali F; FONDAIR study group. Safety and efficacy of low-dose fondaparinux (1.5 mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: the FONDAIR study. J Thromb Haemost. 2012 Nov;10(11):2291-7. doi: 10.1111/j.1538-7836.2012.04908.x.
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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.
Walter Ageno, MD study chair
Università degli Studi dell'Insubria
Francesco Dentali, MD study director
Università degli Studi dell'Insubria
Alessandro Squizzato, MD principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fondaparinux in people with Medical Patients and Renal Insufficiency, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 5 inclusion and 6 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 24 Apr 2012. 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 Italy. 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 was stopped early (reason given: study was stopped after enrolment of about 200 patients for slow recruitment). 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?
major bleeding (time frame: up to 48 hours from last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927602, which also lists 3 linked publications.
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 24 Apr 2012.