Chronic Renal FailurePhase 2/3HeparinNCT01229072
Safe Use of Heparin Sodium in Patients With Chronic Renal Failure.
A Phase 2/3 study testing Heparin sodic and heparin liquemine in people with Chronic Renal Failure, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade, especially the anti-activated factor X. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Heparin sodic and heparin liquemine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Jul 2008
- Phase
- Phase 2/3
- 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
- Adults of both sexes, regardless of color or social class;
- Age above 18 years;
- Patients who agree to participate in the study and signed the free and informed consent (attached);
- Insufficient patients in chronic renal dialysis scheme (3 times per week);
- Low Chronic Renal indication of anticoagulant during dialysis.
Who cannot join
- Not agree to the terms described in informed consent;
- Patients with sensitivity to heparin sodium;
- Volunteer search with hypersensitivity to benzyl alcohol;
- Patients with a history of bleeding or change in blood clotting that can aggravate or terminate the clinical picture, such as tables of gastric ulcer;
- Patients with a history of peptic ulcer;
- Patients with cancer of any etiology, because of the possibility of compromising the function of the variable coagulation;
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- Patients in a period of pregnancy and postpartum;
- Individuals with genetic abnormality of clotting system;
- Patients polytraumatized;
- Patients in use of glucocorticoids for at least 1 month;
- Patients in use of other anticoagulants;
- Patients with high rate of bleeding;
- Patients undergo any surgery performed less than 15 days because of the risk of the formation of hematomas at the site of surgery;
- Patients in use of drugs that affect the hemostasis;
- In addition to these, clinical characteristics that the medical criteria, can interfere with the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000
About this study
Official title: Clinical Study to Assess the Safety of the Use of the Drug Heparin Sodium Produced by the Laboratory Blausiegel Compared in Parallel to the Product Liquemine ® Laboratory Roche in Patients With Chronic Renal Failure.
The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade, especially the anti-activated factor X. The end result of these actions is the inhibition of biochemical training and synthesis of certain clotting factors that activators of critical functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use the treatment of hemodialysis need a system of anticoagulation with the direct thrombin inhibitor and / or heparinóides to prevent thrombosis.
Based on clinical studies, to control the level of plasma heparin in patients with CRF is essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa should be used as a substrate of protection for those patients on hemodialysis.
- Conditions
- Chronic Renal Failure
- Being tested
- Heparin sodic, heparin liquemine
- Keywords
- Safety, Non-inferiority
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin sodicBiological
Heparin sodic 150UI/kg
heparin liquemineBiological
Heparin sodic 150UI/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Heparin Blausiegel Receives: Biological: Heparin sodic |
| 2 | Active comparator | Liquemine Receives: Biological: heparin liquemine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety use of the heparin in patients with renal failure.
Measured: 12 dialysis sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startJul 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Azidus Brasil, Azidus Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229072
- Sponsor's protocol ID
- HEPBLA0108
- Acronym
- Heparin
- Status last verified
- Nov 2022
- First submitted
- 1 Oct 2008
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Safety of the Use of the Drug Heparin Sodium Produced by the Laboratory Blausiegel Compared in Parallel to the Product Liquemine ® Laboratory Roche in Patients With Chronic Renal Failure.
- ClinicalTrials.gov ID
- NCT01229072
- Acronym / sponsor ID
- Heparin / HEPBLA0108
- Conditions
- Chronic Renal Failure
- Keywords
- Safety, Non-inferiority
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Jul 2008 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008
- First posted
- 27 Oct 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 Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade, especially the anti-activated factor X. The end result of these actions is the inhibition of biochemical training and synthesis of certain clotting factors that activators of critical functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use the treatment of hemodialysis need a system of anticoagulation with the direct thrombin inhibitor and / or heparinóides to prevent thrombosis.
Based on clinical studies, to control the level of plasma heparin in patients with CRF is essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa should be used as a substrate of protection for those patients on hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Heparin sodicHeparin Blausiegel |
| 2 | Active comparator | Biological: heparin liquemineLiquemine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults of both sexes, regardless of color or social class;
- Age above 18 years;
- Patients who agree to participate in the study and signed the free and informed consent (attached);
- Insufficient patients in chronic renal dialysis scheme (3 times per week);
- Low Chronic Renal indication of anticoagulant during dialysis.
Key exclusion criteria (15 listed)
- Not agree to the terms described in informed consent;
- Patients with sensitivity to heparin sodium;
- Volunteer search with hypersensitivity to benzyl alcohol;
- Patients with a history of bleeding or change in blood clotting that can aggravate or terminate the clinical picture, such as tables of gastric ulcer;
- Patients with a history of peptic ulcer;
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 |
|---|---|---|
| Heparin sodicHeparin sodic 150UI/kg | Biological | 1 |
| heparin liquemineHeparin sodic 150UI/kg | Biological | 2 |
Primary outcome
Safety use of the heparin in patients with renal failure.
Time frame: 12 dialysis sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Heparin sodic and heparin liquemine in people with Chronic Renal Failure, run by Azidus Brasil at 1 site in Brazil.
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 15 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: paused, as of the sponsor's last update on 3 Nov 2022. 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 Brazil. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Safety use of the heparin in patients with renal failure. (time frame: 12 dialysis sessions). 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 3 Nov 2022.