Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia
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|ClinicalTrials.gov Identifier: NCT00954486|
Recruitment Status : Withdrawn (Difficulty in identifying interested subjects.)
First Posted : August 7, 2009
Last Update Posted : March 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Epoetin alfa||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Experimental: Epoetin alfa, 10,000 units/week
Epoetin alfa is a recombinant erythropoietin.
Drug: Epoetin alfa
Epoetin alfa will be administered at 10,000 units/week
- Change in hemoglobin (Hb) levels [ Time Frame: 14 to 28 weeks ]Measured in mg/dL
- Improve physical function [ Time Frame: 4 to 30 weeks ]Assessed by questionnaire
- Improve cognitive function [ Time Frame: 16 to 30 weeks ]Assessed by questionnaire
- Improve quality of life [ Time Frame: 4 to 30 weeks ]Assessed by questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954486
|United States, California|
|Palo Alto, California, United States, 94304|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Stanley L Schrier, MD||Stanford University|