Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia

Conditions
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Anemia

Intervention / Treatment
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* Drug: Epoetin alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin alfa, 10,000 units/week<br>Epoetin alfa is a recombinant erythropoietin. | Drug: Epoetin alfa<br>* Epoetin alfa will be administered at 10,000 units/week<br>* Other names: Procrit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin (Hb) levels | Measured in mg/dL | 14 to 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve physical function | Assessed by questionnaire | 4 to 30 weeks | 
| Improve cognitive function | Assessed by questionnaire | 16 to 30 weeks | 
| Improve quality of life | Assessed by questionnaire | 4 to 30 weeks |