Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in hemoglobin (Hb) levels [ Time Frame: 14 to 28 weeks ] [ Designated as safety issue: No ]Measured in mg/dL
- Improve physical function [ Time Frame: 4 to 30 weeks ] [ Designated as safety issue: No ]Assessed by questionnaire
- Improve cognitive function [ Time Frame: 16 to 30 weeks ] [ Designated as safety issue: No ]Assessed by questionnaire
- Improve quality of life [ Time Frame: 4 to 30 weeks ] [ Designated as safety issue: No ]Assessed by questionnaire
|Study Start Date:||December 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|