Idiopathic Anemia of Aging (IAA) | NCT00104169

Studies
Idiopathic Anemia of Aging (IAA)

NCT00104169

Sponsor

National Institute on Aging (NIA)

Status

Terminated

Last Update Posted

Aug 29, 2008Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Anemia
Aging

Interventions

Epoetin Alfa

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No subject accrual

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

May 2007Actual

Completion Date

May 2007Actual

First Submitted Date

Feb 23, 2005

First Submission Date that Met QC Criteria

Feb 23, 2005

First Posted Date

Feb 24, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2008

Last Update Posted Date

Aug 29, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Institute on Aging (NIA)NIH

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse idiopathic anemia.

Detailed Description

As individuals become older, the frequency of anemia increases. While the cause of anemia in many cases can be determined and corrected, in a number of individuals there is no correctable cause found and the patient must live with their anemia. This is known as idiopathic anemia, and can have serious consequences for the individual. Numerous studies have demonstrated that anemia is associated with loss of energy and stamina, causing individuals to decrease their activities, which adversely affects both their sense of well-being as well as their physical strength. Losses in these areas are associated with the clinical manifestations of frailty.

The current pilot study will examine whether or not administration of Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse this type of anemia. We will examine the consequences of reversing the anemia in terms of physical strength and function, cardiovascular function and sense of well-being and mental function.

In this study, individuals with anemia will be treated for six months with Epoetin Alfa following the correction of their anemia and measurements done to evaluate physical strength, performance, cardiac, mental and kidney function. At the end of treatment, individuals will be followed for an additional six months to determine whether the anemia recurs and physical function decreases.

Participation in this study is voluntary. All testing and medication received are free to the participant.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Epoetin Alfa	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response of Anemia

Secondary Outcomes

Measure	Description	Time Frame
To determine if there is a beneficial effect of quality of life, cognitive function, and physical function.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

70 years of age or older
Diagnosed with anemia
Hemoglobin level less than or equal to 11
Able to perform most activities of daily living without restriction

Exclusion Criteria:

History of serious heart, liver or kidney disease
Cancer treated within the last year except for skin cancer (excluding melanoma)
Problems with your immune system
Received Epoetin Alfa within the last year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Ershler, MD	NIA, NIH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harbor Hospital		Baltimore	Maryland	21225	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15031309	Background	Cesari M, Penninx BW, Lauretani F, Russo CR, Carter C, Bandinelli S, Atkinson H, Onder G, Pahor M, Ferrucci L. Hemoglobin levels and skeletal muscle: results from the InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):249-54. doi: 10.1093/gerona/59.3.m249.
15238427	Background	Guralnik JM, Eisenstaedt RS, Ferrucci L, Klein HG, Woodman RC. Prevalence of anemia in persons 65 years and older in the United States: evidence for a high rate of unexplained anemia. Blood. 2004 Oct 15;104(8):2263-8. doi: 10.1182/blood-2004-05-1812. Epub 2004 Jul 6.

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

ID	Term
D000740	Anemia
D000073496	Frailty