Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

Anemia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00954486
• Other study ID #: IRB-15270
• Secondary ID: SPO 36101SU-0120
• Status: Withdrawn
• Phase: N/A
• First received: August 5, 2009
• Last updated: March 23, 2016
• Start date: December 2008
• Est. completion date: February 2011

Study information

• Verified date: March 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois
United States	VAPAHCS	Palo Alto	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin (Hb) levels	Measured in mg/dL	14 to 28 weeks	No
Secondary	Improve physical function	Assessed by questionnaire	4 to 30 weeks	No
Secondary	Improve cognitive function	Assessed by questionnaire	16 to 30 weeks	No
Secondary	Improve quality of life	Assessed by questionnaire	4 to 30 weeks	No