HemodialysisPhase 4NCT00347490
HENOX: Enoxaparine in Hemodialysis
A Phase 4 study testing Enoxaparine in people with Hemodialysis, run by Sanofi at 1 site in Thailand.
Trial summary
Primary objective: To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic hemodialysis Secondary objective: To assess safety and tolerability by the number of spontaneously reported adverse events by patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Enoxaparine
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- May 2006to Jun 2007
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage renal failure requiring maintenance hemodialysis at least twice a week
- Has arterio-venous fistula or arterio-venous graft in upper extremities which can apply to blood flow > or = 250ml/min as a vascular access for hemodialysis.
- Stable hemodialysis prescription at least 1 month before enrollment
- UFH (Unfractionated Heparin) was prescribed as an anticoagulant in the previous hemodialysis prescription
- No sign of active infection .
- Absence of recent cardiovascular complication such as myocardial infarction, DVT (Deep Venous Thrombosis), arterial occlusion, pulmonary embolism, cerebrovascular disease in previous 3 months.
Who cannot join
- Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception
- Patients with any evidence of an active bleeding disorder
- Contraindication to anticoagulation:
- Prior history of cerebral hemorrhage at any time
- Coagulopathy (acquired or inherited)
- Recent surgery
Show all 18Show fewer
- Major surgery such as neurosurgery within the past 3 months
- Minor surgery such as intraocular surgery within 1 month.
- Uncontrolled predialytic arterial hypertension (systolic BP > 200 mmHg or diastolic BP > 110 mmHg) at 2 successive readings
- Impaired hemostasis i.e., known or suspected coagulopathy (acquired or inherited): baseline platelet count <100,000/mm3 in patients without baseline diagnosis of active cancer and undergoing chemotherapy treatment (for patients with diagnosis of cancer and undergoing chemotherapy, baseline platelet count >70,000/mm3); aPTT (activated Partial Thromboplastin Time) 1.5X the laboratory upper limit of normal; or international normalized ratio (INR) >1.5
- Indication for thrombolytic therapy such as ischemic heart disease, ischemic stroke.
- Need for a curative treatment of anticoagulant therapy(DVT ,pulmonary embolism, ischemic heart disease)
- Patients treated with oral anticoagulant therapy within 72 hours prior to inclusion
- Patients who have had spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
- Abnormal liver enzyme and total bilirubin within 2 weeks (SGPT, SGOT, total bilirubin above 2 times of Upper normal limit)
- Known hypersensitivity to heparin or LMWH (Low Molecular Weight Heparin), or pork derived products
- History of documented episode of heparin or LMWH induced thrombocytopenia and/or thrombosis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety in Hemodialysis With Enoxaparine
Primary objective:
To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic hemodialysis
Secondary objective:
To assess safety and tolerability by the number of spontaneously reported adverse events by patients
- Conditions
- Hemodialysis
- Being tested
- Enoxaparine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fibrin / clot formation in dialyser and line grade in 10-point scale
Secondary outcomes (1)
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sompob Paibulsirijit, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347490
- Sponsor's protocol ID
- ENOXA_L_00821
- Status last verified
- Jan 2008
- First submitted
- 30 Jun 2006
- Last updated
- 24 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety in Hemodialysis With Enoxaparine
- ClinicalTrials.gov ID
- NCT00347490
- Acronym / sponsor ID
- ENOXA_L_00821
- Conditions
- Hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 4 Jul 2006 (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.
Primary objective:
To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic hemodialysis
Secondary objective:
To assess safety and tolerability by the number of spontaneously reported adverse events by patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- End stage renal failure requiring maintenance hemodialysis at least twice a week
- Has arterio-venous fistula or arterio-venous graft in upper extremities which can apply to blood flow > or = 250ml/min as a vascular access for hemodialysis.
- Stable hemodialysis prescription at least 1 month before enrollment
- UFH (Unfractionated Heparin) was prescribed as an anticoagulant in the previous hemodialysis prescription
- No sign of active infection .
Key exclusion criteria (18 listed)
- Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception
- Patients with any evidence of an active bleeding disorder
- Contraindication to anticoagulation:
- Indication for thrombolytic therapy such as ischemic heart disease, ischemic stroke.
- Need for a curative treatment of anticoagulant therapy(DVT ,pulmonary embolism, ischemic heart disease)
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 |
|---|---|---|
| Enoxaparine | Drug | – |
Primary outcome
Rate of fibrin / clot formation in dialyser and line grade in 10-point scale
1 secondary outcome
Adverse events
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 24 Jan 2008.
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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.
Sompob Paibulsirijit study director
Sanofi
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 Enoxaparine in people with Hemodialysis, run by Sanofi at 1 site in Thailand.
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 6 inclusion and 18 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 24 Jan 2008. 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 Thailand. 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?
Rate of fibrin / clot formation in dialyser and line grade in 10-point scale. 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 24 Jan 2008.