- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00954486
Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia
An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia
Study Overview
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- VAPAHCS
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Illinois
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Chicago, Illinois, United States, 60637
- The University of Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- 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
EXCLUSION CRITERIA:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epoetin alfa, 10,000 units/week
Epoetin alfa is a recombinant erythropoietin.
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Epoetin alfa will be administered at 10,000 units/week
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in hemoglobin (Hb) levels
Time Frame: 14 to 28 weeks
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Measured in mg/dL
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14 to 28 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improve physical function
Time Frame: 4 to 30 weeks
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Assessed by questionnaire
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4 to 30 weeks
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Improve cognitive function
Time Frame: 16 to 30 weeks
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Assessed by questionnaire
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16 to 30 weeks
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Improve quality of life
Time Frame: 4 to 30 weeks
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Assessed by questionnaire
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4 to 30 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stanley L Schrier, MD, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-15270
- SPO 36101 (Other Identifier: Stanford University)
- SU-01202009-159 (Other Identifier: Stanford University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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