AnemiaNCT00954486
Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia
A study testing Epoetin alfa in people with Anemia, run by Stanford University at 3 sites in United States.
Trial summary
The primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary objectives of this study are to assess the ability of epoetin alfa to improve physical function; cognitive function; and quality of life, and to… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2008to Feb 2011
- Phase
- Interventional
- 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
- Aged ≥ 65
- Hb ≤ 11 g/dL
- Outpatient at either the VA Palo Alto Health Care Systems (VAPAHCS) or Stanford Hospital and Clinics (SHC)
- Independently living in the community (ie, not institutionalized or living in a group home)
- Ability to understand and the willingness to sign a written informed consent document
- Performance level ECOG 2 or better
- Diagnosis of unexplained anemia
Who cannot join
- Substance abuse or mental health or other problems that would affect compliance with the protocol
- Predicted mortality based on co-morbidities of less than 3 months
- On any erythropoiesis-stimulating agent in the prior 3 months
- Known HIV; hepatitis B; or hepatitis C chronic infection
- Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study
- Serum albumin < 3 g/dL
Show all 12Show fewer
- Use of an investigational medication or participation in an investigational study within 4 weeks prior to enrollment in the trial
- Liver disease as defined as total bilirubin ≥ 2 g/dL or AST/ALT ≥ 2 times the upper limit of normal
- Allergy to recombinant human erythropoietin
- Estimated glomerular filtration rate by Modification of Diet in Renal Disease (MDRD) equation of < 30 mL/min/1.73 m2 or dialysis
- History of proximal deep venous thrombosis or pulmonary embolism within the past 12 months
- Known contraindication to exercise testing
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Chicago
Chicago, Illinois, 60637
VAPAHCS
Palo Alto, California, 94304
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia
The primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary objectives of this study are to assess the ability of epoetin alfa to improve physical function; cognitive function; and quality of life, and to assess the safety of epoetin alfa in the study population.
Read the detailed description
Eligible subjects will be recruited out of the companion study "Anemia in the Elderly" (NCT00640172), after active participation in that study is complete. Subjects will have had a full hematologic evaluation, and unexplained anemia will have been previously defined.
Subjects will provide baseline physical function testing, including exercise testing on a treadmill and testing how far patients can walk in 6 minutes (walk test), as well as quality of life; activity level; and mental functioning.
Study visits will be weekly, and the dose level may be adjusted to achieve the target hemoglobin level within 16 weeks. Once at target, the drug will be taken for a total of 12 additional weeks. The maximum time on the study drug could be 28 weeks, and the minimum time be on the 14 weeks.
The walk tests and questionnaires will be repeated when the target hemoglobin level is reached, and when treatment is completed. The tests about quality of life, activity level, and mental functioning will be repeated at the end of treatment. Follow-up visits will be every 4 weeks for 12 weeks to check for side effects.
- Conditions
- Anemia
- Being tested
- Epoetin alfa
- 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
Also called Epogen, Procrit
Epoetin alfa will be administered at 10,000 units/week
| Study group | Role | What they receive |
|---|---|---|
| Epoetin alfa, 10,000 units/week | Experimental | Epoetin alfa is a recombinant erythropoietin. Receives: Drug: Epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin (Hb) levels
Measured in mg/dL
Measured: 14 to 28 weeks
Secondary outcomes (3)
Improve physical function
Assessed by questionnaire
Measured: 4 to 30 weeks
Improve cognitive function
Assessed by questionnaire
Measured: 16 to 30 weeks
Improve quality of life
Assessed by questionnaire
Measured: 4 to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startDec 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Difficulty in identifying interested subjects.
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.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Stanley L Schrier, Stanford University
- Investigators
- Stanley L Schrier, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954486
- Sponsor's protocol ID
- IRB-15270
- Other IDs
- SPO 36101, SU-01202009-159
- Status last verified
- Mar 2016
- First submitted
- 5 Aug 2009
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia
- ClinicalTrials.gov ID
- NCT00954486
- Acronym / sponsor ID
- IRB-15270
- Conditions
- Anemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty in identifying interested subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 7 Aug 2009 (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 primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary objectives of this study are to assess the ability of epoetin alfa to improve physical function; cognitive function; and quality of life, and to assess the safety of epoetin alfa in the study population.
Detailed description
Eligible subjects will be recruited out of the companion study "Anemia in the Elderly" (NCT00640172), after active participation in that study is complete. Subjects will have had a full hematologic evaluation, and unexplained anemia will have been previously defined.
Subjects will provide baseline physical function testing, including exercise testing on a treadmill and testing how far patients can walk in 6 minutes (walk test), as well as quality of life; activity level; and mental functioning.
Study visits will be weekly, and the dose level may be adjusted to achieve the target hemoglobin level within 16 weeks. Once at target, the drug will be taken for a total of 12 additional weeks. The maximum time on the study drug could be 28 weeks, and the minimum time be on the 14 weeks.
The walk tests and questionnaires will be repeated when the target hemoglobin level is reached, and when treatment is completed. The tests about quality of life, activity level, and mental functioning will be repeated at the end of treatment. Follow-up visits will be every 4 weeks for 12 weeks to check for side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin alfa, 10,000 units/week | Experimental | Drug: Epoetin alfaEpoetin alfa is a recombinant erythropoietin. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Aged ≥ 65
- Hb ≤ 11 g/dL
- Outpatient at either the VA Palo Alto Health Care Systems (VAPAHCS) or Stanford Hospital and Clinics (SHC)
- Independently living in the community (ie, not institutionalized or living in a group home)
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (12 listed)
- Substance abuse or mental health or other problems that would affect compliance with the protocol
- Predicted mortality based on co-morbidities of less than 3 months
- On any erythropoiesis-stimulating agent in the prior 3 months
- Known HIV; hepatitis B; or hepatitis C chronic infection
- Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational 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 alfaAlso: Epogen, ProcritEpoetin alfa will be administered at 10,000 units/week | Drug | Epoetin alfa, 10,000 units/week |
Primary outcome
Change in hemoglobin (Hb) levels
Time frame: 14 to 28 weeks
Measured in mg/dL
3 secondary outcomes
Improve physical function
Time frame: 4 to 30 weeks
Improve cognitive function
Time frame: 16 to 30 weeks
Improve quality of life
Time frame: 4 to 30 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Stanley L Schrier, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epoetin alfa in people with Anemia, run by Stanford University at 3 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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in hemoglobin (Hb) levels (time frame: 14 to 28 weeks). 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 24 Mar 2016.