AnemiaPhase 2NCT00337441
Treatment of Chronic Anemia With Epoetin Alfa in Elderly
A Phase 2 study testing Epoetin Alfa (drug) in people with Anemia, run by Research and Education Foundation of Michael Reese Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or mobility among elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Epoetin Alfa (drug)
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2003to Jul 2005
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years of age or older Diagnosed with chronic anemia Hemoglobin level less than or equal to 11.5 g/dl Community dwelling Able to make monthly clinic visits
Who cannot join
- Currently on Epoetin alfa or similar preparations Having nutritional anemia Having active cancer or received recent treatment for cancer On treatment for Kidney disease Diagnosis of dementia Inability to ambulate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
Mercy Hospital and Medical Center
Chicago, Illinois, 60616-2477
About this study
Official title: Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa.
The purpose of this study is to determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or mobility among elderly.
Read the detailed description
Chronic Anemia is common among elderly. Given their somewhat non-specific nature, the clinical symptoms of anemia are often difficult to attribute directly to the anemia itself. However, it is known that anemic older adults are at an increased risk of mortality, disability, higher risk of falls, poorer quality of life, worsening cognitive function, increase hospitalization risk, and increased healthcare utilization than their non-anemic counterparts.
Yet so far, there have been no treatment studies to demonstrate the benefits of correction of chronic anemia.
Epoetin Alfa (Procrit) is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrow's production of red blood cells.
This study is to explore, can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue, quality of life or mobility among elderly.
Overall this is a 32 week treatment study.
In this study, participants with chronic anemia will receive either Epoetin alfa or placebo (saline injection) under the skin for 16 weeks. After 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks.
At the end of 32 weeks we will compare, if epoetin alfa corrected the anemia, how individuals felt in respect to their fatigue levels, quality of life and did mobility improve during the study.
- Conditions
- Anemia
- Being tested
- Epoetin Alfa (drug)
- Keywords
- Chronic Anemia, Anemia, Chronic Diseases, Elderly, Epoetin alfa, Fatigue, Quality of life, Mobility
- Medical subject headings
- Anemia, Chronic Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin Alfa (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Fatigue
Quality of Life
Secondary outcomes (2)
Quality of Life
Mobility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJan 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 62 participants
Sponsor and investigators
- Lead sponsor
- Research and Education Foundation of Michael Reese Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C., Cook County Health, Mercy Hospital and Medical Center, Illinois
- Investigators
- Parag Agnihotri, Principal investigator, Research and Education Foundation of Michael Reese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337441
- Sponsor's protocol ID
- PR02-32-031
- Status last verified
- Jun 2006
- First submitted
- 14 Jun 2006
- Last updated
- 16 Jun 2006
- Results posted
- No
Publications
Guralnik JM, Eisenstaedt RS, Ferrucci L, Klein HG, Woodman RC. Prevalence of anemia in persons 65 years and older in the United States: evidence for a high rate of unexplained anemia. Blood. 2004 Oct 15;104(8):2263-8. doi: 10.1182/blood-2004-05-1812. Epub 2004 Jul 6.
PubMed 15238427Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PubMed 15758012Penninx BW, Pahor M, Cesari M, Corsi AM, Woodman RC, Bandinelli S, Guralnik JM, Ferrucci L. Anemia is associated with disability and decreased physical performance and muscle strength in the elderly. J Am Geriatr Soc. 2004 May;52(5):719-24. doi: 10.1111/j.1532-5415.2004.52208.x.
PubMed 15086651Cella D, Zagari MJ, Vandoros C, Gagnon DD, Hurtz HJ, Nortier JW. Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. J Clin Oncol. 2003 Jan 15;21(2):366-73. doi: 10.1200/JCO.2003.02.136.
PubMed 12525531
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Anemia And Fatigue In Elderly Patients: A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa.
- ClinicalTrials.gov ID
- NCT00337441
- Acronym / sponsor ID
- PR02-32-031
- Conditions
- Anemia
- Keywords
- Chronic Anemia, Anemia, Chronic Diseases, Elderly, Epoetin alfa, Fatigue, Quality of life, Mobility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants
- Lead sponsor
- Research and Education Foundation of Michael Reese HospitalUniversity, hospital or other
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C., Cook County Health, Mercy Hospital and Medical Center, Illinois
- Study start
- Jan 2003
- Study completion
- Jul 2005
- First posted
- 16 Jun 2006 (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 determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or mobility among elderly.
Detailed description
Chronic Anemia is common among elderly. Given their somewhat non-specific nature, the clinical symptoms of anemia are often difficult to attribute directly to the anemia itself. However, it is known that anemic older adults are at an increased risk of mortality, disability, higher risk of falls, poorer quality of life, worsening cognitive function, increase hospitalization risk, and increased healthcare utilization than their non-anemic counterparts.
Yet so far, there have been no treatment studies to demonstrate the benefits of correction of chronic anemia.
Epoetin Alfa (Procrit) is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrow's production of red blood cells.
This study is to explore, can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue, quality of life or mobility among elderly.
Overall this is a 32 week treatment study.
In this study, participants with chronic anemia will receive either Epoetin alfa or placebo (saline injection) under the skin for 16 weeks. After 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks.
At the end of 32 weeks we will compare, if epoetin alfa corrected the anemia, how individuals felt in respect to their fatigue levels, quality of life and did mobility improve during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years of age or older Diagnosed with chronic anemia Hemoglobin level less than or equal to 11.5 g/dl Community dwelling Able to make monthly clinic visits
Key exclusion criteria (1 listed)
- Currently on Epoetin alfa or similar preparations Having nutritional anemia Having active cancer or received recent treatment for cancer On treatment for Kidney disease Diagnosis of dementia Inability to ambulate
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) | Drug | – |
Primary outcome
Hemoglobin
Fatigue
Quality of Life
2 secondary outcomes
Quality of Life
Mobility
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2006.
- Background: PubMed 15238427Guralnik JM, Eisenstaedt RS, Ferrucci L, Klein HG, Woodman RC. Prevalence of anemia in persons 65 years and older in the United States: evidence for a high rate of unexplained anemia. Blood. 2004 Oct 15;104(8):2263-8. doi: 10.1182/blood-2004-05-1812. Epub 2004 Jul 6.
- Background: PubMed 15758012Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
- Background: PubMed 15086651Penninx BW, Pahor M, Cesari M, Corsi AM, Woodman RC, Bandinelli S, Guralnik JM, Ferrucci L. Anemia is associated with disability and decreased physical performance and muscle strength in the elderly. J Am Geriatr Soc. 2004 May;52(5):719-24. doi: 10.1111/j.1532-5415.2004.52208.x.
- Background: PubMed 12525531Cella D, Zagari MJ, Vandoros C, Gagnon DD, Hurtz HJ, Nortier JW. Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. J Clin Oncol. 2003 Jan 15;21(2):366-73. doi: 10.1200/JCO.2003.02.136.
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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.
Parag Agnihotri principal investigator
Research and Education Foundation of Michael Reese
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epoetin Alfa (drug) in people with Anemia, run by Research and Education Foundation of Michael Reese Hospital at 2 sites in United States.
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 1 inclusion and 1 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 16 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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. 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?
On the ClinicalTrials.gov record for NCT00337441, which also lists 4 linked publications.
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 16 Jun 2006.