Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

• Status: Withdrawn
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: National Institute on Aging (NIA)
• Treatments: Epoetin Alfa

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