Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing HemodialysisPhase 3NCT01184495
Efficacy Study of Two Formulations of Erythropoietin
A Phase 3 study testing Epoetin Alfa-BioManguinhos and Epoetin Alfa-BioSimilar in people with Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis, run by Hospital de Clinicas de Porto Alegre.
Trial summary
A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis
- What is being tested?
- Epoetin Alfa-BioManguinhos and Epoetin Alfa-BioSimilar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jan 2009
- 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
- We included adult patients with chronic renal failure on hemodialysis for more than three months at the Dialysis Unit of the Department of Nephrology, HCPA and the Center for Dialysis and Transplant (CDT), characterized as as patients on chronic regular dialysis procedure. Patients already in use of EPO for at least three months, only those taking the drug by subcutaneous and agreed to participate in the study.
- Patients using different doses of EPO were included, but these were distributed across the treatment groups by randomization stratum dose of EPO, to ensure even distribution of patients in both groups.
- It was considered that patients with HIV or AIDS who were in treatment for the disease with proper clinical management would be eligible for the study (as exemplified by patients with HIV or AIDS approved for inclusion on the waiting list for cadaveric kidney transplantation) .
- Patients with a history of cancer or already treated in the oncological standpoint, and no signs of disease activity could be included.
Who cannot join
- Patients who had other causes of anemia defined for maintenance, for example, patients with liver cirrhosis, with a history of gastrointestinal bleeding, patients with chronic Gastro Intestinal, Genital or Urinary bleeding or other sites were excluded. Similarly patients with AIDS without treatment, hemolytic anemia, pancytopenia, thalassemia, sickle cell anemia, myelodysplasia, multiple myeloma or other cancers or inflammatory arthritis. There was also no inclusion of patients with intolerance or allergy to iron parenterally, patients without adherence to dialysis or with chronic inadequate dialysis blood flow of vascular access persistently below 250 mL / min, kt / v, as a measure of efficiency of hemodialysis, persistently <1.2) or frequent hospitalizations considered as possible causes of inadequate response to erythropoietin.
- We excluded patients with mental illness or condition that prevents the free consent and signature of informed consent, as well as previous reports of serious adverse effects to the drugs studied.
- Criteria for withdrawal from the clinical trial: a view of the high morbidity of hemodialysis patients, expressed by frequent hospital clinics, it was found that patients in the study would not be withdrawn from the study due to hospitalization, provided that: the hospital did not involve surgery (except vascular access surgery or hospitalization in the intensive care unit or equivalent, or that represent otherwise, a loss of patient follow-up or co-interventions in the treatment of anemia of these).
- Were withdrawn from the study patients who required blood transfusion because they have severe anemia or intervention unrelated to the usual treatment of anemia in hemodialysis patients.
About this study
Official title: Comparison of the Efficacy of Erythropoietin Produced in the Institute of Technology in Immunobiology of the Oswald Cruz Foundation (BioMaguinhos/FioCruz/MS) and Erythropoietin Industrialized in Patients With Chronic Renal Failure
A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis
- Conditions
- Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis
- Being tested
- Epoetin Alfa-BioManguinhos, Epoetin Alfa-BioSimilar
- Keywords
- Erythropoietin, Chronic renal failure, Hemodialysis, Anemia
- Medical subject headings
- Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin Alfa-BioManguinhosDrug
Subcutaneous administration of EPO-BioManguinhos
Epoetin Alfa-BioSimilarDrug
Subcutaneous administration of EPO-BioSimilar
| Study group | Role | What they receive |
|---|---|---|
| Epoetin Bio-Manguinhos | Experimental | Not described Receives: Drug: Epoetin Alfa-BioManguinhos |
| EPO-BioSimilar | Active comparator | Subcutaneous administration of EPO-BioSimilar Receives: Drug: Epoetin Alfa-BioSimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Level in blood
The evaluation of the efficacy between different formulations of recombinant EPO: the one produced by Bio-Manguinhos and produced by private industry was observed in response to EPO as measured by levels of hemoglobin (Hb) results. The mean Hb of the two groups were compared, as well as the variation observed in both groups over time follow-up (six months).
Measured: Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months
Secondary outcomes (1)
Safety
Assessing the safety of the formulation produced by Bio-Manguinhos was performed by comparing the rate of adverse events related to the use of recombinant EPO in the two study groups
Measured: Monthly assessment of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing HemodialysisStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Rio Grande do Sul State Health Department - SES/RS, Oswaldo Cruz Foundation
- Responsible party
- Principal investigator, Paulo Dornelles Picon, Hospital de Clinicas de Porto Alegre
- Investigators
- Paulo Dornelles Picon, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184495
- Sponsor's protocol ID
- 06-168
- Status last verified
- Feb 2017
- First submitted
- 17 Aug 2010
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Picon PD, Pribbernow SC, Prompt CA, Schacher SC, Antunes VV, Mentz BP, Oliveira FL, Souza CM, Schacher FC. Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis. Clinics (Sao Paulo). 2014 Aug;69(8):547-53. doi: 10.6061/clinics/2014(08)08.
PubMed 25141114
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Erythropoietin Produced in the Institute of Technology in Immunobiology of the Oswald Cruz Foundation (BioMaguinhos/FioCruz/MS) and Erythropoietin Industrialized in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT01184495
- Acronym / sponsor ID
- 06-168
- Conditions
- Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis
- Keywords
- Erythropoietin, Chronic renal failure, Hemodialysis, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Rio Grande do Sul State Health Department - SES/RS, Oswaldo Cruz Foundation
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Aug 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.
A double-blind, randomized trial aimed to compare the efficacy of two formulations of erythropoietin in patients with chronic renal failure on hemodialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epoetin Bio-Manguinhos | Experimental | Drug: Epoetin Alfa-BioManguinhos |
| EPO-BioSimilar | Active comparator | Drug: Epoetin Alfa-BioSimilarSubcutaneous administration of EPO-BioSimilar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- We included adult patients with chronic renal failure on hemodialysis for more than three months at the Dialysis Unit of the Department of Nephrology, HCPA and the Center for Dialysis and Transplant (CDT), characterized as as patients on chronic regular dialysis procedure. Patients already in use of EPO for at least three months, only those taking the drug by subcutaneous and agreed to participate in the study.
- Patients using different doses of EPO were included, but these were distributed across the treatment groups by randomization stratum dose of EPO, to ensure even distribution of patients in both groups.
- It was considered that patients with HIV or AIDS who were in treatment for the disease with proper clinical management would be eligible for the study (as exemplified by patients with HIV or AIDS approved for inclusion on the waiting list for cadaveric kidney transplantation) .
- Patients with a history of cancer or already treated in the oncological standpoint, and no signs of disease activity could be included.
Key exclusion criteria (4 listed)
- Patients who had other causes of anemia defined for maintenance, for example, patients with liver cirrhosis, with a history of gastrointestinal bleeding, patients with chronic Gastro Intestinal, Genital or Urinary bleeding or other sites were excluded. Similarly patients with AIDS without treatment, hemolytic anemia, pancytopenia, thalassemia, sickle cell anemia, myelodysplasia, multiple myeloma or other cancers or inflammatory arthritis. There was also no inclusion of patients with intolerance or allergy to iron parenterally, patients without adherence to dialysis or with chronic inadequate dialysis blood flow of vascular access persistently below 250 mL / min, kt / v, as a measure of efficiency of hemodialysis, persistently <1.2) or frequent hospitalizations considered as possible causes of inadequate response to erythropoietin.
- We excluded patients with mental illness or condition that prevents the free consent and signature of informed consent, as well as previous reports of serious adverse effects to the drugs studied.
- Criteria for withdrawal from the clinical trial: a view of the high morbidity of hemodialysis patients, expressed by frequent hospital clinics, it was found that patients in the study would not be withdrawn from the study due to hospitalization, provided that: the hospital did not involve surgery (except vascular access surgery or hospitalization in the intensive care unit or equivalent, or that represent otherwise, a loss of patient follow-up or co-interventions in the treatment of anemia of these).
- Were withdrawn from the study patients who required blood transfusion because they have severe anemia or intervention unrelated to the usual treatment of anemia in hemodialysis patients.
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 |
|---|---|---|
| Epoetin Alfa-BioManguinhosSubcutaneous administration of EPO-BioManguinhos | Drug | Epoetin Bio-Manguinhos |
| Epoetin Alfa-BioSimilarSubcutaneous administration of EPO-BioSimilar | Drug | EPO-BioSimilar |
Primary outcome
Hemoglobin Level in blood
Time frame: Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months
The evaluation of the efficacy between different formulations of recombinant EPO: the one produced by Bio-Manguinhos and produced by private industry was observed in response to EPO as measured by levels of hemoglobin (Hb) results. The mean Hb of the two groups were compared, as well as the variation observed in both groups over time follow-up (six months).
1 secondary outcome
Safety
Time frame: Monthly assessment of adverse events
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 Feb 2017.
- Derived from this study: PubMed 25141114Picon PD, Pribbernow SC, Prompt CA, Schacher SC, Antunes VV, Mentz BP, Oliveira FL, Souza CM, Schacher FC. Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis. Clinics (Sao Paulo). 2014 Aug;69(8):547-53. doi: 10.6061/clinics/2014(08)08.
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.
Paulo Dornelles Picon principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin Alfa-BioManguinhos and Epoetin Alfa-BioSimilar in people with Comparison of the Efficacy of Two Formulations of Epoetin in Patients Undergoing Hemodialysis, run by Hospital de Clinicas de Porto Alegre.
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 4 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 Feb 2017. 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?
Hemoglobin Level in blood (time frame: Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months). 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 NCT01184495, which also lists 1 linked publication.
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 Feb 2017.