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Status:

WITHDRAWN

Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

Lead Sponsor:

Stanford University

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Anemia

Eligibility:

All Genders

65+ years

Phase:

NA

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 ...

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 ev...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2011

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00954486

    Start Date

    December 1 2008

    End Date

    February 1 2011

    Last Update

    March 24 2016

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    VAPAHCS

    Palo Alto, California, United States, 94304

    2

    Stanford University School of Medicine

    Stanford, California, United States, 94305

    3

    The University of Chicago

    Chicago, Illinois, United States, 60637