Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337441
Status:
UNKNOWN
Last Update Posted:
2006-06-16
First Post:
2006-06-14
Brief Title:
Treatment of Chronic Anemia With Epoetin Alfa in Elderly
Sponsor:
Research and Education Foundation of Michael Reese Hospital
Organization:
Research and Education Foundation of Michael Reese Hospital
Study Overview
Official Title:
Chronic Anemia And Fatigue In Elderly Patients A Randomized Double-Blind Placebo-Controlled Cross-Over Study With Epoetin Alfa
Status:
UNKNOWN
Status Verified Date:
2006-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatiguequality of life or mobility among elderly
Detailed Description:
Chronic Anemia is common among elderly Given their somewhat non-specific nature the clinical symptoms of anemia are often difficult to attribute directly to the anemia itself However it is known that anemic older adults are at an increased risk of mortality disability higher risk of falls poorer quality of life worsening cognitive function increase hospitalization risk and increased healthcare utilization than their non-anemic counterparts
Yet so far there have been no treatment studies to demonstrate the benefits of correction of chronic anemia
Epoetin Alfa Procrit is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrows production of red blood cells
This study is to explore can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue quality of life or mobility among elderly
Overall this is a 32 week treatment study
In this study participants with chronic anemia will receive either Epoetin alfa or placebo saline injection under the skin for 16 weeks After 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks
At the end of 32 weeks we will compare if epoetin alfa corrected the anemia how individuals felt in respect to their fatigue levels quality of life and did mobility improve during the study
Yet so far there have been no treatment studies to demonstrate the benefits of correction of chronic anemia
Epoetin Alfa Procrit is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrows production of red blood cells
This study is to explore can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue quality of life or mobility among elderly
Overall this is a 32 week treatment study
In this study participants with chronic anemia will receive either Epoetin alfa or placebo saline injection under the skin for 16 weeks After 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks
At the end of 32 weeks we will compare if epoetin alfa corrected the anemia how individuals felt in respect to their fatigue levels quality of life and did mobility improve during the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None