Chronic Renal FailurePhase 3NCT01346215
Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
A Phase 3 study testing heparin sodium in people with Chronic Renal Failure, run by Laboratório Químico Farmacêutico Bergamo Ltda. at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment. 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 sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2011to Feb 2012
- Phase
- Phase 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
- Patients research that agree to participate in the study and sign the informed consent form;
- Patients aged over 18 years, both sexes, regardless of color or social class;
- Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
- Patients with laboratory results within specified acceptance criteria.
Who cannot join
- Patients who are taking part or took part in another clinical investigational study within 12 months;
- Hypersensitivity to heparin sodium and/or benzyl alcohol;
- History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
- History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
- Severe liver disease;
- Patients in cancer treatment;
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- Pregnant and lactating women;
- Use of glucocorticoids over physiological dose;
- Use of other anticoagulants;
- Patients undergoing any surgery performed less than 15 days;
- History of non response or exacerbated response to heparin sodium;
- Patients who do not adapt to 150 UI/kg dose.
Trial locations and contacts
1 site in 1 country.
Marcelo A. C. Orlandi, Dr. contact
Brazil1 site
Instituto de Nefrologia de Campinas
Campinas, São Paulo
Marcelo Orlandi
About this study
The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.
- Conditions
- Chronic Renal Failure
- Being tested
- heparin sodium
- Keywords
- heparin, renal insufficiency, chronic, extracorporeal dialysis, fibrinolytic agents, anticoagulants, aPTT
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin sodiumBiological
5000 UI/mL
heparin sodiumBiological
5000 UI/mL
| Study group | Role | What they receive |
|---|---|---|
| Actparin® - Laboratorio Bergamo | Experimental | Not described Receives: Biological: heparin sodium |
| Heparin sodium - APP Pharmaceuticals | Active comparator | Not described Receives: Biological: heparin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis
Measured: 4 weeks (12 consecutive sessions)
Secondary outcomes (2)
Pharmacodynamic activity of heparin observed through aPTT marker
Measured: 4 weeks (sessions 1, 6 and 12)
Safety in use of heparin by monitoring adverse events
Measured: 5 weeks (12 consecutive sessions + 1 post treatment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startOct 2011
- 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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratório Químico Farmacêutico Bergamo Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Azidus Brasil
- Investigators
- Marcelo A. C. Orlandi, Dr., Principal investigator, Instituto de Nefrologia de Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346215
- Sponsor's protocol ID
- HEPBER0211
- Status last verified
- Apr 2011
- First submitted
- 28 Apr 2011
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT01346215
- Acronym / sponsor ID
- HEPBER0211
- Conditions
- Chronic Renal Failure
- Keywords
- heparin, renal insufficiency, chronic, extracorporeal dialysis, fibrinolytic agents, anticoagulants, aPTT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Laboratório Químico Farmacêutico Bergamo Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Azidus Brasil
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 2 May 2011 (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 investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actparin® - Laboratorio Bergamo | Experimental | Biological: heparin sodium |
| Heparin sodium - APP Pharmaceuticals | Active comparator | Biological: heparin sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients research that agree to participate in the study and sign the informed consent form;
- Patients aged over 18 years, both sexes, regardless of color or social class;
- Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
- Patients with laboratory results within specified acceptance criteria.
Key exclusion criteria (12 listed)
- Patients who are taking part or took part in another clinical investigational study within 12 months;
- Hypersensitivity to heparin sodium and/or benzyl alcohol;
- History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
- History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
- Severe liver 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 |
|---|---|---|
| heparin sodium5000 UI/mL | Biological | Actparin® - Laboratorio Bergamo |
| heparin sodium5000 UI/mL | Biological | Heparin sodium - APP Pharmaceuticals |
Primary outcome
Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis
Time frame: 4 weeks (12 consecutive sessions)
2 secondary outcomes
Pharmacodynamic activity of heparin observed through aPTT marker
Time frame: 4 weeks (sessions 1, 6 and 12)
Safety in use of heparin by monitoring adverse events
Time frame: 5 weeks (12 consecutive sessions + 1 post treatment session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- MedlinePlusLink provided by the sponsor.
- Blood thinnersLink provided by the sponsor.
- DialysisLink provided by the sponsor.
- Kidney failureLink provided by the sponsor.
- Drug InformationLink provided by the sponsor.
- HeparinLink provided by the sponsor.
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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.
Marcelo A. C. Orlandi, Dr. contact
Marcelo A. C. Orlandi, Dr. principal investigator
Instituto de Nefrologia de Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing heparin sodium in people with Chronic Renal Failure, run by Laboratório Químico Farmacêutico Bergamo Ltda. 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 4 inclusion and 12 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 2 May 2011. 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 phase mean?
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?
Contact Marcelo A. C. Orlandi, Dr., or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis (time frame: 4 weeks (12 consecutive 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 2 May 2011.