Treatment of Chronic Anemia With Epoetin Alfa in Elderly | NCT00337441

Studies
Treatment of Chronic Anemia With Epoetin Alfa in Elderly

NCT00337441

Sponsor

Research and Education Foundation of Michael Reese Hospital

Status

Unknown status

Last Update Posted

Jun 16, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Anemia

Interventions

Epoetin Alfa (drug)

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

Jun 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Jun 14, 2006

First Submission Date that Met QC Criteria

Jun 14, 2006

First Posted Date

Jun 16, 2006Estimated

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

Jun 14, 2006

Last Update Posted Date

Jun 16, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Research and Education Foundation of Michael Reese HospitalOTHER

Collaborators

Name	Class
Ortho Biotech Clinical Affairs, L.L.C.	INDUSTRY
Cook County Health	OTHER_GOV
Mercy Hospital and Medical Center, Illinois	OTHER

Description Module

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 fatigue,quality 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 marrow's 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.

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

Name	Type	Description	Arm Group Labels	Other Names
Epoetin Alfa (drug)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin
Fatigue
Quality of Life

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life
Mobility

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 years of age or older Diagnosed with chronic anemia Hemoglobin level less than or equal to 11.5 g/dl Community dwelling Able to make monthly clinic visits

Exclusion Criteria:

Currently on Epoetin alfa or similar preparations Having nutritional anemia Having active cancer or received recent treatment for cancer On treatment for Kidney disease Diagnosis of dementia Inability to ambulate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 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
Parag Agnihotri	Research and Education Foundation of Michael Reese	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John H. Stroger Jr. Hospital of Cook County		Chicago	Illinois	60612	United States
Mercy Hospital and Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
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.
15758012	Background	Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.

ID	Term
D000740	Anemia
D002908	Chronic Disease
D005221	Fatigue

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D020969	Disease Attributes
D010335	Pathologic Processes

ID	Term
D000068817	Epoetin Alfa
D004364	Pharmaceutical Preparations

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