Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00954486
Recruitment Status : Withdrawn (Difficulty in identifying interested subjects.)
First Posted : August 7, 2009
Last Update Posted : March 24, 2016
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Stanley L Schrier, Stanford University

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Epoetin alfa Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Epoetin alfa, 10,000 units/week
Epoetin alfa is a recombinant erythropoietin.
Drug: Epoetin alfa
Epoetin alfa will be administered at 10,000 units/week
Other Names:
  • Epogen
  • Procrit

Primary Outcome Measures :
  1. Change in hemoglobin (Hb) levels [ Time Frame: 14 to 28 weeks ]
    Measured in mg/dL

Secondary Outcome Measures :
  1. Improve physical function [ Time Frame: 4 to 30 weeks ]
    Assessed by questionnaire

  2. Improve cognitive function [ Time Frame: 16 to 30 weeks ]
    Assessed by questionnaire

  3. Improve quality of life [ Time Frame: 4 to 30 weeks ]
    Assessed by questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954486

United States, California
Palo Alto, California, United States, 94304
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
Stanford University
National Institute on Aging (NIA)
Principal Investigator: Stanley L Schrier, MD Stanford University

Responsible Party: Stanley L Schrier, Principle Investigator, Stanford University Identifier: NCT00954486     History of Changes
Other Study ID Numbers: IRB-15270
SPO 36101 ( Other Identifier: Stanford University )
SU-01202009-159 ( Other Identifier: Stanford University )
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hematologic Diseases
Epoetin Alfa