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 recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00954486
First received: August 5, 2009
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

The primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly community dwelling 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 community dwelling outpatients with unexplained anemia.


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:
  • Assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly community dwelling outpatients with unexplained anemia [ Time Frame: 14 to 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the ability of epoetin alfa to improve physical function [ Time Frame: 4 to 30 weeks ] [ Designated as safety issue: No ]
  • to assess the ability of epoetin alfa to improve cognitive function [ Time Frame: 16 to 30 weeks ] [ Designated as safety issue: No ]
  • to assess the ability of epoetin alfa to improve quality of life [ Time Frame: 4 to 30 weeks ] [ Designated as safety issue: No ]
  • Assess the safety of epoetin alfa in community dwelling outpatients with unexplained anemia [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2008
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Eligible patients will be recruited out of the companion study "Anemia in the Elderly" (PI Stanley Schrier; IRB approved eProtocol No. 5112). They will have had a full hematologic evaluation, and unexplained anemia will have been previously defined. However, their active participation in the prior trial (eProtocol No.5112) will have been completed prior to initiating this intervention. Those who fulfill all inclusion/ exclusion criteria will be asked if they would be interested in participating in this trial.

Active participation in this study will likely last 9-10 months and will include a series of visits (that may occur at either SHC or VAPAHCS) including:

  • Practice Tests Visit: Two to three weeks prior to receiving the study drug epoetin alfa, enrolled subjects will undergo practice physical function testing, including exercise testing on a treadmill and testing how far patients can walk in 6 minutes (walk test).
  • Pre-treatment Tests Visit: Up to 2 weeks prior to treatment, pre-treatment tests will be done. This will include repeating exercise test and walk test and also doing several questionnaires and tests that will assess quality of life, activity level, and mental functioning.
  • Baseline Visit At this visit, subjects will be initiated on the study drug, epoetin alfa, which will be started at a weekly dose of 10,000 units. Subjects will also be given a daily iron pill.

Subjects will be seen weekly and the study medication will be adjusted for a maximum time period of 16 weeks until the target hemoglobin is reached. Once at target, the drug will be taken for a total of 12 additional weeks. Thus, the maximum time you could be on the study drug is 28 weeks, and the minimum time you could be on the study drug is 14 weeks.

After you reach a stable dose of study medication, you will have repeat testing with the walk tests and questionnaires assessing how you feel about your quality of life.

After you have finished the period when you will be receiving the study drug, you will repeat the exercise test and walk test and also the questionnaires and tests that will assess how you feel about your quality of life, your activity level, and your mental functioning.

After you have finished the study medication, you will be seen in clinic every 4 weeks for 12 weeks to check for side effects.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:a) Aged >= 65 b) Hb <= 11 g/dL c) Outpatient at either the VA Palo Alto Health Care Systems (VAPAHCS) or Stanford Hospital and Clinics (SHC) d) Independently living in the community (i.e. not institutionalized or living in a group home) e) Ability to understand and the willingness to sign a written informed consent document f) Performance level ECOG 2 or better g) Diagnosis of unexplained anemia

Exclusion Criteria:a) Substance abuse or mental health or other problems that would affect compliance with the protocol b) Predicted mortality based on co-morbidities of less than 3 months c) On any erythropoiesis-stimulating agent in the prior 3 months d) Known HIV, hepatitis B or hepatitis C chronic infection e) Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study f) Serum albumin < 3 g/dL g) Use of an investigational medication or participation in an investigational study within 4 weeks prior to enrollment in the trial h) Liver disease as defined as total bilirubin >= 2 g/dL or AST/ALT >= 2 times the upper limit of normal i) Allergy to recombinant human erythropoietin j) Estimated glomerular filtration rate by Modification of Diet in Renal Disease (MDRD) equation of < 30 ml/min/1.73 m2 or dialysis k) History of proximal deep venous thrombosis or pulmonary embolism within the past 12 months l) 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

Contacts
Contact: Renee Mehra, BS, PG Dip (650) 736-1836 ramehra@stanford.edu

Locations
United States, California
VAPAHCS Recruiting
Palo Alto, California, United States, 94304
Contact: Renee Mehra, BS., PG Dip    650-736-1836    ramehra@stanford.edu   
Principal Investigator: Lawrence Leung         
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Renee Mehra, BS, PG Dip    650-736-1836    ramehra@stanford.edu   
Principal Investigator: Stanley L Schrier         
Sub-Investigator: Elizabeth Price         
United States, Illinois
The University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Karuna Naik    773-834-2603    knaik@bsd.uchicago.edu   
Sub-Investigator: Andrew Artz         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Stanley L Schrier Stanford University
  More Information

No publications provided

Responsible Party: Stanley L Schrier, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00954486     History of Changes
Other Study ID Numbers: SU-01202009-1598, SPO #36101, eProtocol 15270
Study First Received: August 5, 2009
Last Updated: February 18, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014