Stanford, California 94304

  • Anemia

Purpose:

Anemia is a common problem in the elderly. Approximately 30% of elderly patients with anemia do have an identifiable cause of the anemia. The purpose of this study is to evaluate whether intravenous iron administration in older adults with unexplained anemia could improve their clinical prognosis of anemia, cognitive and physical function, and overall quality of life. This study will constitute a randomized, controlled, open-label treatment versus wait-list/delayed intervention control group, multi-institutional pilot trial of intravenous iron sucrose in adults 65 years and older with unexplained anemia, a hemoglobin (Hb) between 9.0 g/dL and 11.5 g/dL for women and between 9.0 g/dL and 12.7 g/dL for men, and a serum ferritin between 20 and 100 ng/mL. Treatment will entail receiving IV iron either immediately (immediate intervention group) or following a wait list period of 12 weeks (wait list control group) on a weekly basis until total dose completion. IV iron sucrose will be administered during the treatment phase as weekly 200 mg infusions for 5 doses. Hypothesis: - Intravenous iron can improve mean 6 Minute Walk Test (6MWT) by at least 50 meters in adults 65 years and older with unexplained anemia and a serum ferritin between 20 and 100 ng/mL. - Intravenous iron will lead to an increase in hemoglobin (Hb) in adults 65 years and older with unexplained anemia and a serum ferritin between 20 and 100 ng/mL.


Criteria:

Inclusion Criteria: 1. Age >= 65 years old 2. Hb concentration >= 9.0 g/dL and < 11.5 g/dL for women and >= 9.0 to , 12.7 g/dL for men 3. Unexplained anemia 4. Serum ferritin level >= 20 and <= 100 ng/mL 5. Able to walk without the use of a walker, motorized device or the assistance of another person 6. Must be able to understand and be willing to provide written informed consent in the absence of dementia, defined as a Montreal Cognitive Assessment (MoCA) score >= 22 7. Must be able to understand and speak English Exclusion Criteria: 1. Red blood cell transfusions within the past 3 months 2. Use of erythropoiesis stimulating agents (ESA) in the past 3 months 3. Intravenous Iron Infusions within the past 3 months 4. History of unstable angina or myocardial infarction in the past 3 months 5. Distance on 6MWT above the median for age and sex adjusted population medians 6. History of stroke of transient ischemic attacks in the past 3 months 7. Uncontrolled hypertension defined as greater than the average diastolic blood pressure > 100 mm Hg or systolic blood pressure > 160 mm Hg on 2 separate occasions on 2 separate days during screening 8. Positive fecal occult blood test within the screening period 9. Elevated AST (SGOT) or ALT (SGPT) >= 2x upper limit of normal 10. Documented anaphylactic reaction to iron sucrose infusion in the past 11. Subjects initiated on oral iron supplementation within the last 6 weeks, or those initiated on oral iron within the last 3 months who have had at least a one g/dL improvement in Hb since starting oral iron supplementation


Study is Available At:


Original ID:

21230


NCT ID:

NCT01413919


Secondary ID:

1U01AG034661-01


Study Acronym:

IV iron


Brief Title:

Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia and a Serum Ferritin Between 20 and 100 ng/mL


Official Title:

Phase II: Randomized, Open-Label, Wait-list Control Trial to Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia and a Serum Ferritin Between 20 and 100 ng/mL Partnership for Anemia: Clinical and Translational Trials in the E


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

65 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Stanford University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Elizabeth A Price, MD
eaprice@stanford.edu

Study Dates

Start Date:August 2011
Primary Completion Date:December 2012
Primary Completion Type:Anticipated
Verification Date:August 2011
Last Changed Date:August 25, 2011
First Received Date:August 9, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Assess efficacy and safety of IV iron sucrose in older anemic adults; Quantify impact of anemia treatment by IV iron sucrose by geriatric evaluation panel
Time Frame:18 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change of 6MWT distance from baseline to 12 weeks
Time Frame:12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Intravenous iron sucrose
Description:Treatment will entail receiving IV iron either immediately (immediate intervention group) or following a wait list period of 12 weeks (wait list control group) on a weekly basis until total dose completion.
Arm Name:Immediate intervention
Intervention Type:Drug
Name:Intravenous iron sucrose
Description:Treatment will entail receiving IV iron either immediately (immediate intervention group) or following a wait list period of 12 weeks (wait list control group) on a weekly basis until total dose completion.
Arm Name:Wait-list control

Study Arms

Study Arm Type:Experimental
Arm Name:Immediate intervention
Study Arm Type:Experimental
Arm Name:Wait-list control

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Stanford University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 17, 2021

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