PharmacodynamicsPhase 2/3NCT01034488

Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure

A Phase 2/3 study testing Suine in people with Pharmacodynamics, run by Azidus Brasil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

1. Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pharmacodynamics
What is being tested?: Suine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: No sites listed yet
Study dates: Aug 2010to Feb 2012
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 over 18 years, with good clinical doctor's discretion;
Patients research that agree to participate in the study and sign the informed consent form (attached);
Chronic renal failure patients in hemodialysis (3 times per week). chronic renal failure patients with indication for anticoagulation during dialysis

Who cannot join

Non compliance with the terms described in the informed consent FICT;
Patients suffering from sensitivity studies heparin sodium;
Patients with hypersensitivity to search benzyl alcohol;
Patients with search history of bleeding disorders or disease that a bleeding disorder can worsen or terminate the clinical picture, for example, frames of gastric ulcer;
Patients with a history of research peptic ulcer;
Patient with cancer research because of the possibility of impairment of variable coagulation function;

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Patients who are research during pregnancy and postpartum;
Individuals with a genetic abnormality of the coagulation system;
Trauma patients;
Patients on glucocorticoid therapy for at least 1 month;
Patients using other anticoagulants;
Patients with a high rate of bleeding;
Patients undergoing any surgery performed less than 15 days due to the risk of bruising at the site of surgery.
Patients using drugs that affect hemostasis
Patients using the following drugs: Salicylates systemic aspirin and other NSAIDs, including ketorolac, Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.

About this study

Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. In addition, heparin and ATIII inactivate other proteases of the coagulation cascade, especially the anti-activated factor X. The outcome of these biochemical actions is the inhibition of the formation and synthesis of activators of the clotting factors that exert critical functions in the genesis of the blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent thrombosis. Based on clinical studies, the control of plasma heparin level in patients with CRF is essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa factor to be used as a substrate for protection for those patients undergoing hemodialysis.
Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in patients with renal failure who do hemodialysis treatment.

Conditions: Pharmacodynamics
Being tested: Suine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SuineBiological
5000UI /mL
SuineBiological
5000UI/mL

Study groups in NCT01034488
Study group	Role	What they receive
Heparin sodium - APP	Active comparator	5000UI / mL Receives: Biological: Suine
Heparin - Eurofarma	Experimental	5000 UI/ mL Receives: Biological: Suine

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect (activity) of heparin observed for markers for aPTT and anti-Xa.
Measured: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.

Secondary outcomes (2)

Effectiveness in maintaining the absence clotting during hemodialysis.
Measured: 12 consecutive sessions
Safety in use of the drug by monitoring events complicating the use of heparin
Measured: 12 consecutive sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Feb 2012

First posted17 Dec 2009 (estimated)
Study startAug 2010
Primary completionDec 2011 (estimated)
Study completionFeb 2012 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PharmacodynamicsStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01034488
Sponsor's protocol ID: HEPEUR1009
Other IDs: Version 01
Status last verified: Jan 2011
First submitted: 16 Dec 2009
Last updated: 28 Jan 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pharmacodynamics trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure
ClinicalTrials.gov ID: NCT01034488
Acronym / sponsor ID: HEPEUR1009
Conditions: Pharmacodynamics
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 128 participants (estimated)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Dec 2011 (estimated)
Study completion: Feb 2012 (estimated)
First posted: 17 Dec 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.

Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. In addition, heparin and ATIII inactivate other proteases of the coagulation cascade, especially the anti-activated factor X. The outcome of these biochemical actions is the inhibition of the formation and synthesis of activators of the clotting factors that exert critical functions in the genesis of the blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent thrombosis. Based on clinical studies, the control of plasma heparin level in patients with CRF is essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa factor to be used as a substrate for protection for those patients undergoing hemodialysis.
Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in patients with renal failure who do hemodialysis treatment.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Heparin sodium - APP	Active comparator	Biological: Suine5000UI / mL
Heparin - Eurofarma	Experimental	Biological: Suine5000 UI/ mL

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults of both sexes, regardless of color or social class;
Age over 18 years, with good clinical doctor's discretion;
Patients research that agree to participate in the study and sign the informed consent form (attached);
Chronic renal failure patients in hemodialysis (3 times per week). chronic renal failure patients with indication for anticoagulation during dialysis

Key exclusion criteria (15 listed)

Non compliance with the terms described in the informed consent FICT;
Patients suffering from sensitivity studies heparin sodium;
Patients with hypersensitivity to search benzyl alcohol;
Patients with search history of bleeding disorders or disease that a bleeding disorder can worsen or terminate the clinical picture, for example, frames of gastric ulcer;
Patients with a history of research 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
Suine5000UI /mL	Biological	Heparin sodium - APP
Suine5000UI/mL	Biological	Heparin - Eurofarma

Primary outcome

Effect (activity) of heparin observed for markers for aPTT and anti-Xa.
Time frame: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.

2 secondary outcomes

Effectiveness in maintaining the absence clotting during hemodialysis.
Time frame: 12 consecutive sessions
Safety in use of the drug by monitoring events complicating the use of heparin
Time frame: 12 consecutive sessions

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.

Related trials for Pharmacodynamics

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Suine in people with Pharmacodynamics, run by Azidus Brasil.

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 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: status not confirmed, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

Effect (activity) of heparin observed for markers for aPTT and anti-Xa. (time frame: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.). 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 NCT01034488.

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 28 Jan 2011.