Renal InsufficiencyPhase 1FONDA PKNCT01121770
"Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"
A Phase 1 study testing fondaparinux sodium injection in people with Renal Insufficiency, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- fondaparinux sodium injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2013
- Phase
- Phase 1
- 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
- Inpatients who are 18 years or older
- estimated creatinine clearances between 20-50 ml/min
- current hospitalization for a cancer-related abdominal, breast surgery or elective orthopedic surgery
- able to give informed consent
- need for prophylactic anticoagulant therapy for increased risk of a thrombotic episode
Who cannot join
- clopidogrel, aspirin, or NSAID usage,(usage is prohibited while patients are participating in the study)
- body weight < 50 kg
- anticoagulation therapy for thrombosis or other indication
- pregnant or breast-feeding
- hypersensitivity to Arixtra®
- thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of Arixtra®
Show all 9Show fewer
- bacterial endocarditis
- brain malignancy
- increased risk of bleeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction
The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.
- Conditions
- Renal Insufficiency
- Being tested
- fondaparinux sodium injection
- 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 sodium injectionDrug
1.5mg subcutaneously every day
| Study group | Role | What they receive |
|---|---|---|
| Arixtra | Experimental | Not described Receives: Drug: fondaparinux sodium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood samples to measure specific Arixtra® concentration
peak level will be collected 2-3 hours after the dose interval level will be collected between peak and midpoint midpoint level will be collected 12 hours after the dose interval level will be collected midpoint and trough trough level will be collected just prior to the next scheduled dose
Measured: • Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra
Secondary outcomes (1)
Frequency of bleeding events and new thrombotic events
events will be used to compare to rates in patients without renal dysfunction
Measured: Daily assessments will be made for bleeding and thrombosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Thomas L Ortel, M.D, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121770
- Sponsor's protocol ID
- Pro00021052
- Other IDs
- 112972
- Acronym
- FONDA PK
- Status last verified
- Aug 2014
- First submitted
- 6 May 2010
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction
- ClinicalTrials.gov ID
- NCT01121770
- Acronym / sponsor ID
- FONDA PK / Pro00021052
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 May 2010 (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 study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arixtra | Experimental | Drug: fondaparinux sodium injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatients who are 18 years or older
- estimated creatinine clearances between 20-50 ml/min
- current hospitalization for a cancer-related abdominal, breast surgery or elective orthopedic surgery
- able to give informed consent
- need for prophylactic anticoagulant therapy for increased risk of a thrombotic episode
Key exclusion criteria (9 listed)
- clopidogrel, aspirin, or NSAID usage,(usage is prohibited while patients are participating in the study)
- body weight < 50 kg
- anticoagulation therapy for thrombosis or other indication
- pregnant or breast-feeding
- hypersensitivity to Arixtra®
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 sodium injection1.5mg subcutaneously every day | Drug | Arixtra |
Primary outcome
Blood samples to measure specific Arixtra® concentration
Time frame: • Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra
peak level will be collected 2-3 hours after the dose interval level will be collected between peak and midpoint midpoint level will be collected 12 hours after the dose interval level will be collected midpoint and trough trough level will be collected just prior to the next scheduled dose
1 secondary outcome
Frequency of bleeding events and new thrombotic events
Time frame: Daily assessments will be made for bleeding and thrombosis
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 1 Sep 2014.
- The Duke Hemostasis \& Thrombosis Center provides a multidisciplinary approach to the diagnosis and management of a wide variety of hemostatic disorders and is a leader in basic research effort. Click here for more information about this study.Link provided by the sponsor.
Related trials for Renal Insufficiency
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Thomas L Ortel, M.D, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fondaparinux sodium injection in people with Renal Insufficiency, run by Duke University at 1 site in United States.
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 9 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 1 Sep 2014. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Blood samples to measure specific Arixtra® concentration (time frame: • Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra). 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 1 Sep 2014.