An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia - NCT00954486-94305(Clinical Trial 422001)
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Stanford |
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State:
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CA |
| Zip Code: |
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94305 |
| Conditions: |
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Anemia |
| Purpose: |
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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 community dwelling 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 community dwelling outpatients with unexplained anemia.
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| Study summary: |
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Eligible patients will be recruited out of the companion study "Anemia in the Elderly" (PI
Stanley Schrier; IRB approved eProtocol No. 5112). They will have had a full hematologic
evaluation, and unexplained anemia will have been previously defined. However, their active
participation in the prior trial (eProtocol No.5112) will have been completed prior to
initiating this intervention. Those who fulfill all inclusion/ exclusion criteria will be
asked if they would be interested in participating in this trial.
Active participation in this study will likely last 9-10 months and will include a series of
visits (that may occur at either SHC or VAPAHCS) including:
- Practice Tests Visit: Two to three weeks prior to receiving the study drug epoetin
alfa, enrolled subjects will undergo practice physical function testing, including
exercise testing on a treadmill and testing how far patients can walk in 6 minutes
(walk test).
- Pre-treatment Tests Visit: Up to 2 weeks prior to treatment, pre-treatment tests will
be done. This will include repeating exercise test and walk test and also doing several
questionnaires and tests that will assess quality of life, activity level, and mental
functioning.
- Baseline Visit At this visit, subjects will be initiated on the study drug, epoetin
alfa, which will be started at a weekly dose of 10,000 units. Subjects will also be
given a daily iron pill.
Subjects will be seen weekly and the study medication will be adjusted for a maximum time
period of 16 weeks until the target hemoglobin is reached. Once at target, the drug will be
taken for a total of 12 additional weeks. Thus, the maximum time you could be on the study
drug is 28 weeks, and the minimum time you could be on the study drug is 14 weeks.
After you reach a stable dose of study medication, you will have repeat testing with the
walk tests and questionnaires assessing how you feel about your quality of life.
After you have finished the period when you will be receiving the study drug, you will
repeat the exercise test and walk test and also the questionnaires and tests that will
assess how you feel about your quality of life, your activity level, and your mental
functioning.
After you have finished the study medication, you will be seen in clinic every 4 weeks for
12 weeks to check for side effects. |
| Criteria: |
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Inclusion Criteria:a) Aged >= 65 b) Hb <= 11 g/dL c) Outpatient at either the VA Palo Alto
Health Care Systems (VAPAHCS) or Stanford Hospital and Clinics (SHC) d) Independently
living in the community (i.e. not institutionalized or living in a group home) e) Ability
to understand and the willingness to sign a written informed consent document f)
Performance level ECOG 2 or better g) Diagnosis of unexplained anemia
Exclusion Criteria:a) Substance abuse or mental health or other problems that would affect
compliance with the protocol b) Predicted mortality based on co-morbidities of less than 3
months c) On any erythropoiesis-stimulating agent in the prior 3 months d) Known HIV,
hepatitis B or hepatitis C chronic infection e) Clinically significant and uncontrolled
medical condition considered a high risk for participation in an investigational study f)
Serum albumin < 3 g/dL g) Use of an investigational medication or participation in an
investigational study within 4 weeks prior to enrollment in the trial h) Liver disease as
defined as total bilirubin >= 2 g/dL or AST/ALT >= 2 times the upper limit of normal i)
Allergy to recombinant human erythropoietin j) Estimated glomerular filtration rate by
Modification of Diet in Renal Disease (MDRD) equation of < 30 ml/min/1.73 m2 or dialysis
k) History of proximal deep venous thrombosis or pulmonary embolism within the past 12
months l) Known contraindication to exercise testing |
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| Study is available at: |
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Stanford University School of Medicine
Stanford, CA 94305
United States
Primary Contact:
Renee Mehra, BS, PG Dip
Email: ramehra@stanford.edu
Phone: 650-736-1836
Secondary Contact:
Renee Mehra, BS, PG Dip
Email: ramehra@stanford.edu
Phone: (650) 736-1836 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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