AnemiaPhase 2NCT00104169
Idiopathic Anemia of Aging (IAA)
A Phase 2 study testing Epoetin Alfa in people with Anemia and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse idiopathic anemia. Read more about this study
- Who is it for?
- Ages 70 years and older
- What is being tested?
- Epoetin Alfa
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to May 2007
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years of age or older
- Diagnosed with anemia
- Hemoglobin level less than or equal to 11
- Able to perform most activities of daily living without restriction
Who cannot join
- History of serious heart, liver or kidney disease
- Cancer treated within the last year except for skin cancer (excluding melanoma)
- Problems with your immune system
- Received Epoetin Alfa within the last year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Epoetin Alfa in Idiopathic Anemia of Aging (IAA)
The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse idiopathic anemia.
Read the detailed description
As individuals become older, the frequency of anemia increases. While the cause of anemia in many cases can be determined and corrected, in a number of individuals there is no correctable cause found and the patient must live with their anemia. This is known as idiopathic anemia, and can have serious consequences for the individual. Numerous studies have demonstrated that anemia is associated with loss of energy and stamina, causing individuals to decrease their activities, which adversely affects both their sense of well-being as well as their physical strength. Losses in these areas are associated with the clinical manifestations of frailty.
The current pilot study will examine whether or not administration of Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse this type of anemia. We will examine the consequences of reversing the anemia in terms of physical strength and function, cardiovascular function and sense of well-being and mental function.
In this study, individuals with anemia will be treated for six months with Epoetin Alfa following the correction of their anemia and measurements done to evaluate physical strength, performance, cardiac, mental and kidney function. At the end of treatment, individuals will be followed for an additional six months to determine whether the anemia recurs and physical function decreases.
Participation in this study is voluntary. All testing and medication received are free to the participant.
- Being tested
- Epoetin Alfa
- Keywords
- Anemia, Frailty, Epoetin, Erythropoietin, EPO
- Medical subject headings
- Anemia, Frailty
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.
Response of Anemia
Secondary outcomes (1)
To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2005 (estimated)
- Study startAug 2004
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: No subject accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Non-randomised
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- William Ershler, MD, Principal investigator, NIA, NIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104169
- Sponsor's protocol ID
- AG0014
- Status last verified
- Aug 2008
- First submitted
- 23 Feb 2005
- Last updated
- 29 Aug 2008
- Results posted
- No
Publications
Cesari M, Penninx BW, Lauretani F, Russo CR, Carter C, Bandinelli S, Atkinson H, Onder G, Pahor M, Ferrucci L. Hemoglobin levels and skeletal muscle: results from the InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):249-54. doi: 10.1093/gerona/59.3.m249.
PubMed 15031309Guralnik 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 15238427Penninx BW, Guralnik JM, Onder G, Ferrucci L, Wallace RB, Pahor M. Anemia and decline in physical performance among older persons. Am J Med. 2003 Aug 1;115(2):104-10. doi: 10.1016/s0002-9343(03)00263-8.
PubMed 12893395Chaves PH, Ashar B, Guralnik JM, Fried LP. Looking at the relationship between hemoglobin concentration and prevalent mobility difficulty in older women. Should the criteria currently used to define anemia in older people be reevaluated? J Am Geriatr Soc. 2002 Jul;50(7):1257-64. doi: 10.1046/j.1532-5415.2002.50313.x.
PubMed 12133021Kikuchi M, Inagaki T, Shinagawa N. Five-year survival of older people with anemia: variation with hemoglobin concentration. J Am Geriatr Soc. 2001 Sep;49(9):1226-8. doi: 10.1046/j.1532-5415.2001.49241.x.
PubMed 11559383
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Epoetin Alfa in Idiopathic Anemia of Aging (IAA)
- ClinicalTrials.gov ID
- NCT00104169
- Acronym / sponsor ID
- AG0014
- Keywords
- Anemia, Frailty, Epoetin, Erythropoietin, EPO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No subject accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Aug 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 24 Feb 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 trial is to examine whether Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse idiopathic anemia.
Detailed description
As individuals become older, the frequency of anemia increases. While the cause of anemia in many cases can be determined and corrected, in a number of individuals there is no correctable cause found and the patient must live with their anemia. This is known as idiopathic anemia, and can have serious consequences for the individual. Numerous studies have demonstrated that anemia is associated with loss of energy and stamina, causing individuals to decrease their activities, which adversely affects both their sense of well-being as well as their physical strength. Losses in these areas are associated with the clinical manifestations of frailty.
The current pilot study will examine whether or not administration of Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse this type of anemia. We will examine the consequences of reversing the anemia in terms of physical strength and function, cardiovascular function and sense of well-being and mental function.
In this study, individuals with anemia will be treated for six months with Epoetin Alfa following the correction of their anemia and measurements done to evaluate physical strength, performance, cardiac, mental and kidney function. At the end of treatment, individuals will be followed for an additional six months to determine whether the anemia recurs and physical function decreases.
Participation in this study is voluntary. All testing and medication received are free to the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 70 years of age or older
- Diagnosed with anemia
- Hemoglobin level less than or equal to 11
- Able to perform most activities of daily living without restriction
Key exclusion criteria (4 listed)
- History of serious heart, liver or kidney disease
- Cancer treated within the last year except for skin cancer (excluding melanoma)
- Problems with your immune system
- Received Epoetin Alfa within the last year
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
Response of Anemia
1 secondary outcome
To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.
Results and safety
The study was stopped early (reason given: No subject accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2008.
- Background: PubMed 15031309Cesari M, Penninx BW, Lauretani F, Russo CR, Carter C, Bandinelli S, Atkinson H, Onder G, Pahor M, Ferrucci L. Hemoglobin levels and skeletal muscle: results from the InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):249-54. doi: 10.1093/gerona/59.3.m249.
- 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 12893395Penninx BW, Guralnik JM, Onder G, Ferrucci L, Wallace RB, Pahor M. Anemia and decline in physical performance among older persons. Am J Med. 2003 Aug 1;115(2):104-10. doi: 10.1016/s0002-9343(03)00263-8.
- Background: PubMed 12133021Chaves PH, Ashar B, Guralnik JM, Fried LP. Looking at the relationship between hemoglobin concentration and prevalent mobility difficulty in older women. Should the criteria currently used to define anemia in older people be reevaluated? J Am Geriatr Soc. 2002 Jul;50(7):1257-64. doi: 10.1046/j.1532-5415.2002.50313.x.
- Background: PubMed 11559383Kikuchi M, Inagaki T, Shinagawa N. Five-year survival of older people with anemia: variation with hemoglobin concentration. J Am Geriatr Soc. 2001 Sep;49(9):1226-8. doi: 10.1046/j.1532-5415.2001.49241.x.
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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.
William Ershler, MD principal investigator
NIA, NIH
1 site 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 in people with Anemia and Aging, run by National Institute on Aging (NIA) at 1 site 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 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: stopped early, as of the sponsor's last update on 29 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: No subject accrual). 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?
Response of Anemia. 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 NCT00104169, which also lists 5 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 29 Aug 2008.