NCT00954486

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

August 5, 2009

Last Update Submit

March 23, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin (Hb) levels

    Measured in mg/dL

    14 to 28 weeks

Secondary Outcomes (3)

  • Improve physical function

    4 to 30 weeks

  • Improve cognitive function

    16 to 30 weeks

  • Improve quality of life

    4 to 30 weeks

Study Arms (1)

Epoetin alfa, 10,000 units/week

EXPERIMENTAL

Epoetin alfa is a recombinant erythropoietin.

Drug: Epoetin alfa

Interventions

Epoetin alfaDRUG

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

Also known as: Epogen, Procrit
Epoetin alfa, 10,000 units/week

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VAPAHCS

Palo Alto, California, 94304, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Stanley L Schrier, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 7, 2009

Study Start

December 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 24, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)