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| Sponsor: | Stanford University |
|---|---|
| Collaborator: |
National Institute on Aging (NIA) |
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT00954486 |
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 |
| 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) |
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:
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 |
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| Contact: Renee Mehra, BS, PG Dip | (650) 736-1836 | ramehra@stanford.edu |
| 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 | |
| Principal Investigator: | Stanley L Schrier | Stanford University |
More Information
| 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 |
|
Anemia Hematologic Diseases Epoetin Alfa Hematinics |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
