Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

An Open-Label, Single-Arm Pilot Study of the Efficacy of Erythropoietin Alfa in Improving Peak Oxygen Consumption in Elderly Subjects With Unexplained Anemia

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.

Study Overview

• Status: Withdrawn
• Conditions: Anemia
• Intervention / Treatment: Drug: Epoetin alfa

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VAPAHCS
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin (Hb) levels	Measured in mg/dL	14 to 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve physical function	Assessed by questionnaire	4 to 30 weeks
Improve cognitive function	Assessed by questionnaire	16 to 30 weeks
Improve quality of life	Assessed by questionnaire	4 to 30 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Stanley L Schrier, MD, Stanford University

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: August 5, 2009
• First Submitted That Met QC Criteria: August 6, 2009
• First Posted (Estimate): August 7, 2009

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Hematinics; Epoetin Alfa
• Other Study ID Numbers: IRB-15270; SPO 36101 (Other Identifier: Stanford University); SU-01202009-159 (Other Identifier: Stanford University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO