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Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

This study has been withdrawn prior to enrollment.
(Difficulty in identifying interested subjects.)
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Stanley L Schrier, Stanford University
ClinicalTrials.gov Identifier:
NCT00954486
First received: August 5, 2009
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
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 Intervention
Anemia
Drug: Epoetin alfa

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change in hemoglobin (Hb) levels [ Time Frame: 14 to 28 weeks ] [ Designated as safety issue: No ]
    Measured in mg/dL


Secondary Outcome Measures:
  • Improve physical function [ Time Frame: 4 to 30 weeks ] [ Designated as safety issue: No ]
    Assessed by questionnaire

  • Improve cognitive function [ Time Frame: 16 to 30 weeks ] [ Designated as safety issue: No ]
    Assessed by questionnaire

  • Improve quality of life [ Time Frame: 4 to 30 weeks ] [ Designated as safety issue: No ]
    Assessed by questionnaire


Enrollment: 0
Study Start Date: December 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954486

Locations
United States, California
VAPAHCS
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)
Investigators
Principal Investigator: Stanley L Schrier, MD Stanford University
  More Information

Responsible Party: Stanley L Schrier, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00954486     History of Changes
Other Study ID Numbers: IRB-15270  SPO 36101  SU-01202009-159 
Study First Received: August 5, 2009
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on September 29, 2016