An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia
Recruitment status was Recruiting
|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|
- Assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly community dwelling outpatients with unexplained anemia [ Time Frame: 14 to 28 weeks ] [ Designated as safety issue: No ]
- Assess the ability of epoetin alfa to improve physical function [ Time Frame: 4 to 30 weeks ] [ Designated as safety issue: No ]
- to assess the ability of epoetin alfa to improve cognitive function [ Time Frame: 16 to 30 weeks ] [ Designated as safety issue: No ]
- to assess the ability of epoetin alfa to improve quality of life [ Time Frame: 4 to 30 weeks ] [ Designated as safety issue: No ]
- Assess the safety of epoetin alfa in community dwelling outpatients with unexplained anemia [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||February 2011|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954486
|Contact: Renee Mehra, BS, PG Dip||(650) email@example.com|
|United States, California|
|Palo Alto, California, United States, 94304|
|Contact: Renee Mehra, BS., PG Dip 650-736-1836 firstname.lastname@example.org|
|Principal Investigator: Lawrence Leung|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Renee Mehra, BS, PG Dip 650-736-1836 email@example.com|
|Principal Investigator: Stanley L Schrier|
|Sub-Investigator: Elizabeth Price|
|United States, Illinois|
|The University of Chicago||Not yet recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Karuna Naik 773-834-2603 firstname.lastname@example.org|
|Sub-Investigator: Andrew Artz|
|Principal Investigator:||Stanley L Schrier||Stanford University|