AnemiaPhase 3NCT00091910
Research Into the Treatment of Anemia for Critically Ill Patients Admitted to Intensive Care Units (ICU)
A Phase 3 study testing Epoetin alfa in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the production of red cells in the bone marrow. The purpose of this research study is to demonstrate that the administration EPO to critically ill subjects in the intensive care unit (ICU) reduces the number of patients requiring… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Epoetin alfa
- How many people
- 1,460 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Jun 2006
- 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
- Critically ill patient admitted to the ICU
- Patient is anemic when entering the study (hemoglobin </= 12.0 g/dL)
Who cannot join
- Patients with a history of blood clots (deep vein thrombosis)
- Patients with acute ischemic cardiac disease
- Patients receiving hemodialysis or peritoneal dialysis
- Patients admitted to the ICU because of acute GI bleeding
- Patients who are planned to be discharged from the ICU within 48 hours of entering the study
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects
Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the production of red cells in the bone marrow. The purpose of this research study is to demonstrate that the administration EPO to critically ill subjects in the intensive care unit (ICU) reduces the number of patients requiring red blood cell (RBC) transfusion as compared with placebo (a liquid without active medicine).
Read the detailed description
In this study the amount of drug and frequency of dosing is under investigation. Erythropoietin (EPO) will be given by subcutaneous injection (a small needle prick placed underneath the skin). The maximum number of injections a patient may receive is 3. The total expected length of time of patient participation in the study is about 140 days (about 5months).
This study consists of a screening period, treatment period and post treatment period. The study doctor will determine whether the patient is suitable for the study. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.
Eligible patients will be assigned by chance (like flipping a coin) to one of two treatment groups; 40,000 units of EPO or Placebo. Unless the need arises, neither the patient nor the study staff, will know which treatment the patient receives.
The patient will receive an injection of study drug on Study Days 1, 8 and 15 as long as they remain in the same hospital and their hemoglobin (Hb) level is less than 12g/dL. If the patient's hemoglobin level is greater than 12g/dL on any scheduled medication day, study medication will not be given. However the patient will remain in the study and a re-assessment will be done at the next dosing time point. The patient will also receive iron therapy (at least 150 mg) from Study Day 1 (if tolerated) through Study Day 29 or until the patient is discharge from the hospital or withdraws from the study (whichever comes first).
Treatment with study drug will be stopped if the patient become pregnant, or the study doctor feels that it is in the patient's best interest. If treatment is stopped before Study Day 15, the patient will be required to return for scheduled study assessments through Study Day 140.
The purpose of the post-treatment period is to monitor the patient's health status. Whether or not the patient remains hospitalized, the patient will have two more visits to monitor their health (on Study Day 42 and 140). In addition, the study doctor and nurse will contact the patient or their caregiver by phone monthly following the Study Day 29 visit until Study Day 140. Weekly subcutaneous injections (under the skin) of 40,000 units of EPO or placebo on days 1, 8 and 15.
- Conditions
- Anemia
- Being tested
- Epoetin alfa
- Keywords
- Anemia, Epoetin alfa, Erythropoietin, Blood transfusion, Intensive care units
- 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.
The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.
Secondary outcomes (1)
Cumulative number of units of red blood cell transfusions received from Study Day 1 through Study Day 42, Change in hemoglobin from Study Day 1 through Study Day 29, Mortality through Study Day 29 and Cumulative mortality through Study Day 140.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2004 (estimated)
- Study startSep 2003
- Study completionJun 2006
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 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 1,460 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
- NCT00091910
- Sponsor's protocol ID
- CR004114
- Status last verified
- Apr 2010
- First submitted
- 19 Sep 2004
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.
PubMed 17804841
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Epoetin Alfa in Critically Ill Subjects
- ClinicalTrials.gov ID
- NCT00091910
- Acronym / sponsor ID
- CR004114
- Conditions
- Anemia
- Keywords
- Anemia, Epoetin alfa, Erythropoietin, Blood transfusion, Intensive care units
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,460 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Jun 2006 (actual)
- First posted
- 21 Sep 2004 (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.
Erythropoietin (EPO) is a hormone produced in the kidney. Its function is to stimulate the production of red cells in the bone marrow. The purpose of this research study is to demonstrate that the administration EPO to critically ill subjects in the intensive care unit (ICU) reduces the number of patients requiring red blood cell (RBC) transfusion as compared with placebo (a liquid without active medicine).
Detailed description
In this study the amount of drug and frequency of dosing is under investigation. Erythropoietin (EPO) will be given by subcutaneous injection (a small needle prick placed underneath the skin). The maximum number of injections a patient may receive is 3. The total expected length of time of patient participation in the study is about 140 days (about 5months).
This study consists of a screening period, treatment period and post treatment period. The study doctor will determine whether the patient is suitable for the study. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.
Eligible patients will be assigned by chance (like flipping a coin) to one of two treatment groups; 40,000 units of EPO or Placebo. Unless the need arises, neither the patient nor the study staff, will know which treatment the patient receives.
The patient will receive an injection of study drug on Study Days 1, 8 and 15 as long as they remain in the same hospital and their hemoglobin (Hb) level is less than 12g/dL. If the patient's hemoglobin level is greater than 12g/dL on any scheduled medication day, study medication will not be given. However the patient will remain in the study and a re-assessment will be done at the next dosing time point. The patient will also receive iron therapy (at least 150 mg) from Study Day 1 (if tolerated) through Study Day 29 or until the patient is discharge from the hospital or withdraws from the study (whichever comes first).
Treatment with study drug will be stopped if the patient become pregnant, or the study doctor feels that it is in the patient's best interest. If treatment is stopped before Study Day 15, the patient will be required to return for scheduled study assessments through Study Day 140.
The purpose of the post-treatment period is to monitor the patient's health status. Whether or not the patient remains hospitalized, the patient will have two more visits to monitor their health (on Study Day 42 and 140). In addition, the study doctor and nurse will contact the patient or their caregiver by phone monthly following the Study Day 29 visit until Study Day 140. Weekly subcutaneous injections (under the skin) of 40,000 units of EPO or placebo on days 1, 8 and 15.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critically ill patient admitted to the ICU
- Patient is anemic when entering the study (hemoglobin </= 12.0 g/dL)
Key exclusion criteria (5 listed)
- Patients with a history of blood clots (deep vein thrombosis)
- Patients with acute ischemic cardiac disease
- Patients receiving hemodialysis or peritoneal dialysis
- Patients admitted to the ICU because of acute GI bleeding
- Patients who are planned to be discharged from the ICU within 48 hours of entering the 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
The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.
1 secondary outcome
Cumulative number of units of red blood cell transfusions received from Study Day 1 through Study Day 42, Change in hemoglobin from Study Day 1 through Study Day 29, Mortality through Study Day 29 and Cumulative mortality through Study Day 140.
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 8 Jun 2011.
- Results publication: PubMed 17804841Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.
- Research Into the Treatment of Anemia for Critically Ill Patients Admitted to Intensive Care Units (ICU)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 2 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 8 Jun 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?
The primary objective of this study is to demonstrate that the administration of epoetin alfa to critically ill subjects reduces the proportion of subjects requiring red blood cell (RBC) transfusion as compared with placebo at Study Day 29.. 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 NCT00091910, 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 8 Jun 2011.