Hemodialysis ComplicationPhase 3HEPIRCNCT05148377
UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.
A Phase 3 study testing Liquaemin and Heptar in people with Hemodialysis Complication, run by Eurofarma Laboratorios S.A..
Trial summary
The objective of this study was to verify the clinical non-inferiority of the pharmacodynamic effects and the safety of use of the drug Heptar® manufactured by Eurofarma Laboratory, compared to the drug Liquemine®, manufactured by by Roche Laboratory in patients with renal failure undergoing hemodialysis treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Liquaemin and Heptar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2007to 1 Dec 2008
- 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
- Adults of both sexes, regardless of color or social class;
- Age over 18 years, with good clinical characteristics at medical discretion;
- Research patients who agree to participate in the study and sign the consent form free and informed;
- Chronic renal failure patients on dialysis regimen (3 times a week).
- Chronic Kidney Failure with indication for anticoagulant during dialysis
Who cannot join
- Not agreeing with the terms described in the informed consent;
- Research patients with sensitivity to sadistic heparin;
- Research patients with hypersensitivity to benzyl alcohol;
- Research patients with a history of bleeding or disease that change in coagulation may worsen or terminate the clinical picture, such as ulcer gastric;
- Research patients with a history of peptic ulcer.
About this study
The objective of this study was to verify the clinical non-inferiority of the pharmacodynamic effects and the safety of use of the drug Heptar® manufactured by Eurofarma Laboratory, compared to the drug Liquemine®, manufactured by by Roche Laboratory in patients with renal failure undergoing hemodialysis treatment
Read the detailed description
Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparino tested. The study was conducted with the participation of 110 chronic renal failure patients of both sexes. over 18 years old who are undergoing hemodialysis treatment 3 times a week and who fit inclusion and exclusion criteria. The investigational products properly patients were administered during 12 consecutive treatment sessions. Hemodialysis at a dose of 150 IU per kg of weight. The study patients were followed clinically and on a laboratory basis in all hemodialysis sessions according to criteria established by the protocol for verifying the safety in use of the product in study.
The evaluation parameters are:
- Pharmacodynamic effect curve (activity) of heparin verified by dosing of TYPE and anti-Xa markers.
- Effectiveness in maintaining blood coagulation during hemodialysis.
- Blood loss by coagulation of the system;
- Blood clotting and venous capillary loss;
- Trunk of the capillary diolysor in the 12 follow-up sessions.
- Safety in drug use through event monitoring complicating the use of heparin as:
- Increased hematocrit of the patient;
- Thrombocytopenia;
- Bruise;
- Fever;
- Reactions to allergic agents;
- Conditions
- Hemodialysis Complication
- Being tested
- Liquaemin, Heptar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquaeminDrug
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
HeptarDrug
Also called Sodium heparin
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
| Study group | Role | What they receive |
|---|---|---|
| Sodium heparin (Heptar) | Experimental | Sodium heparin (Heptar®) produced by Eurofarma Laboratory, Receives: Drug: Heptar |
| Liquemine® | Active comparator | Roche Lab's Liquemine® Receives: Drug: Liquaemin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss due to system coagulation during 4 weeks of hemodialysis
Evaluation of the change of the useful volume of the system below
Measured: 4 weeks
Loss of venous capillary by clot formation during 4 weeks of hemodialysis
Absolut difference of dialyzer lost between the two groups of treatment in the 12 hemodialysis sessions
Measured: 4 weeks
Change of the useful volume of the system in the dialyzer (priming of dialyzer)
Occurrence of events related to the reduction of the useful volume of the system below 80% by thrombus formation in the dialyzer in the 12 hemodialysis sessions
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Aug 2007
- Primary completion1 Dec 2008
- Study completion1 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparin tested.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148377
- Sponsor's protocol ID
- EF101
- Acronym
- HEPIRC
- Status last verified
- Jan 2020
- First submitted
- 26 Dec 2019
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.
- ClinicalTrials.gov ID
- NCT05148377
- Acronym / sponsor ID
- HEPIRC / EF101
- Conditions
- Hemodialysis Complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 1 Dec 2008 (actual)
- Study completion
- 1 Dec 2008 (actual)
- First posted
- 8 Dec 2021 (actual)
- 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 objective of this study was to verify the clinical non-inferiority of the pharmacodynamic effects and the safety of use of the drug Heptar® manufactured by Eurofarma Laboratory, compared to the drug Liquemine®, manufactured by by Roche Laboratory in patients with renal failure undergoing hemodialysis treatment
Detailed description
Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparino tested. The study was conducted with the participation of 110 chronic renal failure patients of both sexes. over 18 years old who are undergoing hemodialysis treatment 3 times a week and who fit inclusion and exclusion criteria. The investigational products properly patients were administered during 12 consecutive treatment sessions. Hemodialysis at a dose of 150 IU per kg of weight. The study patients were followed clinically and on a laboratory basis in all hemodialysis sessions according to criteria established by the protocol for verifying the safety in use of the product in study.
The evaluation parameters are:
- Pharmacodynamic effect curve (activity) of heparin verified by dosing of TYPE and anti-Xa markers.
- Effectiveness in maintaining blood coagulation during hemodialysis.
- Blood loss by coagulation of the system;
- Blood clotting and venous capillary loss;
- Trunk of the capillary diolysor in the 12 follow-up sessions.
- Safety in drug use through event monitoring complicating the use of heparin as:
- Increased hematocrit of the patient;
- Thrombocytopenia;
- Bruise;
- Fever;
- Reactions to allergic agents;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparin tested.
| Arm | Type | Receives |
|---|---|---|
| Sodium heparin (Heptar) | Experimental | Drug: HeptarSodium heparin (Heptar®) produced by Eurofarma Laboratory, |
| Liquemine® | Active comparator | Drug: LiquaeminRoche Lab's Liquemine® |
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 over 18 years, with good clinical characteristics at medical discretion;
- Research patients who agree to participate in the study and sign the consent form free and informed;
- Chronic renal failure patients on dialysis regimen (3 times a week).
- Chronic Kidney Failure with indication for anticoagulant during dialysis
Key exclusion criteria (5 listed)
- Not agreeing with the terms described in the informed consent;
- Research patients with sensitivity to sadistic heparin;
- Research patients with hypersensitivity to benzyl alcohol;
- Research patients with a history of bleeding or disease that change in coagulation may worsen or terminate the clinical picture, such as ulcer gastric;
- Research 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 |
|---|---|---|
| LiquaeminThe standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment. | Drug | Liquemine® |
| HeptarAlso: Sodium heparinThe standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment. | Drug | Sodium heparin (Heptar) |
Primary outcome
Blood loss due to system coagulation during 4 weeks of hemodialysis
Time frame: 4 weeks
Evaluation of the change of the useful volume of the system below
Loss of venous capillary by clot formation during 4 weeks of hemodialysis
Time frame: 4 weeks
Absolut difference of dialyzer lost between the two groups of treatment in the 12 hemodialysis sessions
Change of the useful volume of the system in the dialyzer (priming of dialyzer)
Time frame: 4 weeks
Occurrence of events related to the reduction of the useful volume of the system below 80% by thrombus formation in the dialyzer in the 12 hemodialysis sessions
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 27 Dec 2021.
- Individual participant dataSharing planned: No
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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 3 study testing Liquaemin and Heptar in people with Hemodialysis Complication, run by Eurofarma Laboratorios S.A..
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 5 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 27 Dec 2021. 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 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?
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?
Blood loss due to system coagulation during 4 weeks of hemodialysis (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 27 Dec 2021.