AnemiaPhase 3NCT00270179
A Study to Evaluate the Effectiveness and Safety of Epoetin Alfa During the Period When One is Donating One's Own Blood Before Surgery.
A Phase 3 study testing epoetin alfa in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow to produce red blood cells and therefore increases a patient's ability to self-donate blood prior to major surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia
- What is being tested?
- epoetin alfa
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Start not givento May 1988
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for major orthopedic surgery
- expected to have surgery between 25 and 35 days after starting epoetin alfa and expected to require transfusion of at least 3 units of red blood
- in good general health, with no clinically significantly abnormalities in blood and urine test values, blood clotting, or tests that check for blood in the feces
- who are not severely obese
Who cannot join
- Patients with a history of blood disease other than mild anemia or currently having a percentage of red blood cells >50% of the blood
- having the presence or history of significant diseases, especially those known to be carried in the blood, to affect the blood, or that require chemotherapy or other drugs that suppress resistance to disease or red blood cells
- having a history of seizure or uncontrolled hypertension
- having clinically significant bleeding in the stomach/intestines or elsewhere
- received a blood transfusion or received androgen therapy within 1 month prior to the start of study
About this study
Official title: A Double-Blind, Placebo-Controlled Study to Determine Whether R-huEPO Can Facilitate Presurgical Autologous Blood Donation and to Determine Its Safety for This Purpose
The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow to produce red blood cells and therefore increases a patient's ability to self-donate blood prior to major surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Read the detailed description
Major surgical procedures may require several units of blood. Blood transfusions from other people may be associated with transfusion reactions that cause fever or uncommonly, blood-borne infections. However, self-blood collections may cause anemia in a patient who will be undergoing surgery a few weeks later. Previous research with epoetin alfa suggests that it increases the rate of red blood cell production and has a beneficial effect on anemia. This randomized, double-blind, placebo-controlled 21-day study is designed to determine whether intravenous epoetin alfa will stimulate a patient's bone marrow to produce red blood cells and therefore increase a patient's ability to self-donate blood prior to major surgery for joint disease. Patients will be randomly assigned to receive either epoetin alfa 600 units per kilogram of body weight or a matching volume of placebo injected into a vein on the first study day and every 3 to 4 days thereafter for 21 days, for a total of 6 doses. The primary measures of effectiveness will be determined by the number of units of blood that can be obtained from patients during the study, the change in hemoglobin and hematocrit from pre-study to post-study, and the number of transfusions required around the time of surgery. Safety will be evaluated based on laboratory tests, vital signs, and the incidence and severity of any adverse or unusual experiences associated with drug administration. The study hypothesis is that patients treated with epoetin alfa will be able to donate more units of blood for their own surgery while receiving epoetin alfa than patients receiving placebo. Epoetin alfa 600 units per kilogram or an equal volume of placebo injected into a vein on the first day of the study, and every 3 to 4 days thereafter until day 21, for a total of 6 doses.
- Conditions
- Anemia
- Being tested
- epoetin alfa
- Keywords
- Anemia, blood transfusion, epoetin alfa, erythropoietin, surgery, self-blood donation
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Units of blood that can be obtained per patient; Change from pre-study to post-study in hemoglobin and hematocrit; Transfusions required around the time of surgery
Secondary outcomes (1)
Safety (clinical laboratory tests, vital signs, incidence and severity of any adverse or unusual experiences associated with drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study completionMay 1988
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Masking
- Double blind
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270179
- Sponsor's protocol ID
- CR005926
- Status last verified
- Apr 2010
- First submitted
- 22 Dec 2005
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study to Determine Whether R-huEPO Can Facilitate Presurgical Autologous Blood Donation and to Determine Its Safety for This Purpose
- ClinicalTrials.gov ID
- NCT00270179
- Acronym / sponsor ID
- CR005926
- Conditions
- Anemia
- Keywords
- Anemia, blood transfusion, epoetin alfa, erythropoietin, surgery, self-blood donation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study completion
- May 1988 (actual)
- First posted
- 26 Dec 2005 (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 evaluate the whether epoetin alfa stimulates the bone marrow to produce red blood cells and therefore increases a patient's ability to self-donate blood prior to major surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Detailed description
Major surgical procedures may require several units of blood. Blood transfusions from other people may be associated with transfusion reactions that cause fever or uncommonly, blood-borne infections. However, self-blood collections may cause anemia in a patient who will be undergoing surgery a few weeks later. Previous research with epoetin alfa suggests that it increases the rate of red blood cell production and has a beneficial effect on anemia. This randomized, double-blind, placebo-controlled 21-day study is designed to determine whether intravenous epoetin alfa will stimulate a patient's bone marrow to produce red blood cells and therefore increase a patient's ability to self-donate blood prior to major surgery for joint disease. Patients will be randomly assigned to receive either epoetin alfa 600 units per kilogram of body weight or a matching volume of placebo injected into a vein on the first study day and every 3 to 4 days thereafter for 21 days, for a total of 6 doses. The primary measures of effectiveness will be determined by the number of units of blood that can be obtained from patients during the study, the change in hemoglobin and hematocrit from pre-study to post-study, and the number of transfusions required around the time of surgery. Safety will be evaluated based on laboratory tests, vital signs, and the incidence and severity of any adverse or unusual experiences associated with drug administration. The study hypothesis is that patients treated with epoetin alfa will be able to donate more units of blood for their own surgery while receiving epoetin alfa than patients receiving placebo. Epoetin alfa 600 units per kilogram or an equal volume of placebo injected into a vein on the first day of the study, and every 3 to 4 days thereafter until day 21, for a total of 6 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for major orthopedic surgery
- expected to have surgery between 25 and 35 days after starting epoetin alfa and expected to require transfusion of at least 3 units of red blood
- in good general health, with no clinically significantly abnormalities in blood and urine test values, blood clotting, or tests that check for blood in the feces
- who are not severely obese
Key exclusion criteria (5 listed)
- Patients with a history of blood disease other than mild anemia or currently having a percentage of red blood cells >50% of the blood
- having the presence or history of significant diseases, especially those known to be carried in the blood, to affect the blood, or that require chemotherapy or other drugs that suppress resistance to disease or red blood cells
- having a history of seizure or uncontrolled hypertension
- having clinically significant bleeding in the stomach/intestines or elsewhere
- received a blood transfusion or received androgen therapy within 1 month prior to the start of study
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 | Drug | – |
Primary outcome
Units of blood that can be obtained per patient; Change from pre-study to post-study in hemoglobin and hematocrit; Transfusions required around the time of surgery
1 secondary outcome
Safety (clinical laboratory tests, vital signs, incidence and severity of any adverse or unusual experiences associated with drug administration)
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 18 May 2011.
- A study to evaluate the effectiveness and safety of epoetin alfa during the period when one is donating one's own blood before surgery.Link 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 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 18 May 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 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?
Units of blood that can be obtained per patient; Change from pre-study to post-study in hemoglobin and hematocrit; Transfusions required around the time of surgery. 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 18 May 2011.