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Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

Primary Purpose

Anemia

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Epoetin alfa

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

Aged ≥ 65
Hb ≤ 11 g/dL
Outpatient at either the VA Palo Alto Health Care Systems (VAPAHCS) or Stanford Hospital and Clinics (SHC)
Independently living in the community (ie, not institutionalized or living in a group home)
Ability to understand and the willingness to sign a written informed consent document
Performance level ECOG 2 or better
Diagnosis of unexplained anemia

EXCLUSION CRITERIA:

Substance abuse or mental health or other problems that would affect compliance with the protocol
Predicted mortality based on co-morbidities of less than 3 months
On any erythropoiesis-stimulating agent in the prior 3 months
Known HIV; hepatitis B; or hepatitis C chronic infection
Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study
Serum albumin < 3 g/dL
Use of an investigational medication or participation in an investigational study within 4 weeks prior to enrollment in the trial
Liver disease as defined as total bilirubin ≥ 2 g/dL or AST/ALT ≥ 2 times the upper limit of normal
Allergy to recombinant human erythropoietin
Estimated glomerular filtration rate by Modification of Diet in Renal Disease (MDRD) equation of < 30 mL/min/1.73 m2 or dialysis
History of proximal deep venous thrombosis or pulmonary embolism within the past 12 months
Known contraindication to exercise testing

Sites / Locations

VAPAHCS
Stanford University School of Medicine
The University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epoetin alfa, 10,000 units/week

Arm Description

Epoetin alfa is a recombinant erythropoietin.

Outcomes

Primary Outcome Measures

Change in hemoglobin (Hb) levels

Measured in mg/dL

Secondary Outcome Measures

Improve physical function

Assessed by questionnaire

Improve cognitive function

Assessed by questionnaire

Improve quality of life

Assessed by questionnaire

Full Information

NCT ID

NCT00954486

First Posted

August 5, 2009

Last Updated

March 23, 2016

Sponsor

Stanford University

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT00954486

Brief Title

Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Difficulty in identifying interested subjects.

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary objectives of this study are to assess the ability of epoetin alfa to improve physical function; cognitive function; and quality of life, and to assess the safety of epoetin alfa in the study population.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epoetin alfa, 10,000 units/week

Arm Type

Experimental

Arm Description

Epoetin alfa is a recombinant erythropoietin.

Intervention Type

Drug

Intervention Name(s)

Epoetin alfa

Other Intervention Name(s)

Epogen, Procrit

Intervention Description

Epoetin alfa will be administered at 10,000 units/week

Primary Outcome Measure Information:

Title

Change in hemoglobin (Hb) levels

Description

Measured in mg/dL

Time Frame

14 to 28 weeks

Secondary Outcome Measure Information:

Title

Improve physical function

Description

Assessed by questionnaire

Time Frame

4 to 30 weeks

Title

Improve cognitive function

Description

Assessed by questionnaire

Time Frame

16 to 30 weeks

Title

Improve quality of life

Description

Assessed by questionnaire

Time Frame

4 to 30 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Aged ≥ 65 Hb ≤ 11 g/dL Outpatient at either the VA Palo Alto Health Care Systems (VAPAHCS) or Stanford Hospital and Clinics (SHC) Independently living in the community (ie, not institutionalized or living in a group home) Ability to understand and the willingness to sign a written informed consent document Performance level ECOG 2 or better Diagnosis of unexplained anemia EXCLUSION CRITERIA: Substance abuse or mental health or other problems that would affect compliance with the protocol Predicted mortality based on co-morbidities of less than 3 months On any erythropoiesis-stimulating agent in the prior 3 months Known HIV; hepatitis B; or hepatitis C chronic infection Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study Serum albumin < 3 g/dL Use of an investigational medication or participation in an investigational study within 4 weeks prior to enrollment in the trial Liver disease as defined as total bilirubin ≥ 2 g/dL or AST/ALT ≥ 2 times the upper limit of normal Allergy to recombinant human erythropoietin Estimated glomerular filtration rate by Modification of Diet in Renal Disease (MDRD) equation of < 30 mL/min/1.73 m2 or dialysis History of proximal deep venous thrombosis or pulmonary embolism within the past 12 months Known contraindication to exercise testing

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stanley L Schrier, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

VAPAHCS

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

The University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

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