Chronic Renal FailurePhase 2/3heparinNCT00828776
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
A Phase 2/3 study testing Heparin sodic - Cristália and heparin - Liquemine (Roche) in people with Chronic Renal Failure, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and… 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 - Cristália and heparin - Liquemine (Roche)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2007to Mar 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 over 18 years with a good clinical medical criteria
- Patients who agreed to participate and signed the Informed Consent
- Insufficient patients in chronic renal dialysis schedule (3 times per week)
- Patients with creatinine clearance <30ml/min
- Patients with indication for anticoagulation during hemodialysis
Who cannot join
- Patients with sensitivity to heparin sodium;
- Patients with hypersensitivity to benzyl alcohol
- Patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer
- Patients with a history of peptic ulcer
- Patients with body mass index greater than 30
- Cancer patients because of the possibility of compromising the function of the variable coagulation
Show all 16Show fewer
- Patients in period of pregnancy or after delivery
- Patients with genetic abnormality of the clotting system
- Polytraumatized patients
- Patients using glucocorticoids for at least 1 month
- Patients using other anticoagulants
- Patients with high rate of bleeding
- Patients undergoing any surgery performed less than 15 days due to the risk of training of hematoma at the site of surgery
- Hypertension above 140/90 mmHg
- Patients using medications that could affect hemostasis
- Patients using the following medicines: hormonal anti not including Ketorolac; Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.
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 Trial of Pharmacodynamic Effects and Non-Clinical Inferiority of the Drug Heparin Sodium Produced by the Laboratory Cristália When Compared With the Product Liquemine of Roche Laboratory in Patients With Chronic Renal Failure
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.
- Conditions
- Chronic Renal Failure
- Being tested
- Heparin sodic - Cristália, heparin - Liquemine (Roche)
- Keywords
- TTPa, Anti-Xa, Adverse Reactions
- 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 sodic - CristáliaBiological
5000UI/mL
heparin - Liquemine (Roche)Biological
5000UI/mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Heparin Cristália Receives: Biological: Heparin sodic - Cristália |
| 2 | Active comparator | Heparin - Roche Receives: Biological: heparin - Liquemine (Roche) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTPA Anti-Xa Adverse Reactions
Measured: 12 consecutive sessions of hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionMar 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828776
- Sponsor's protocol ID
- HEPCRI0907
- Acronym
- heparin
- Status last verified
- Jan 2009
- First submitted
- 23 Jan 2009
- Last updated
- 26 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Pharmacodynamic Effects and Non-Clinical Inferiority of the Drug Heparin Sodium Produced by the Laboratory Cristália When Compared With the Product Liquemine of Roche Laboratory in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT00828776
- Acronym / sponsor ID
- heparin / HEPCRI0907
- Conditions
- Chronic Renal Failure
- Keywords
- TTPa, Anti-Xa, Adverse Reactions
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 26 Jan 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.
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of 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 sodic - CristáliaHeparin Cristália |
| 2 | Active comparator | Biological: heparin - Liquemine (Roche)Heparin - Roche |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults of both sexes, regardless of color or social class
- Age over 18 years with a good clinical medical criteria
- Patients who agreed to participate and signed the Informed Consent
- Insufficient patients in chronic renal dialysis schedule (3 times per week)
- Patients with creatinine clearance <30ml/min
Key exclusion criteria (16 listed)
- Patients with sensitivity to heparin sodium;
- Patients with hypersensitivity to benzyl alcohol
- Patients with a history of bleeding or illness that can change the blood coagulation aggravate or terminate the clinical picture, such as tables of gastric ulcer
- Patients with a history of peptic ulcer
- Patients with body mass index greater than 30
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 sodic - Cristália5000UI/mL | Biological | 1 |
| heparin - Liquemine (Roche)5000UI/mL | Biological | 2 |
Primary outcome
TTPA Anti-Xa Adverse Reactions
Time frame: 12 consecutive sessions of hemodialysis
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 26 Jan 2009.
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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 - Cristália and heparin - Liquemine (Roche) 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 6 inclusion and 16 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 26 Jan 2009. 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?
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?
TTPA Anti-Xa Adverse Reactions (time frame: 12 consecutive sessions of hemodialysis). 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 26 Jan 2009.