Clinical trial NCT01309659: Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia
Official title: A 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 200 ng/mL
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anemia
Unexplained Anemia (UAE)
Keywords: Anemia
Unexplained anemia
elderly
geriatric
older adults
UAE
over 65
iron
pactte
pactee
aging
aged
old
older
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-03-07
Enrollment: 19
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether treatment of unexplained anemia in older adults with a short course of weekly intravenous iron infusions can improve physical activity and therefore quality of life.

Detailed description: There is a tremendous morbidity and mortality associated with anemia in the elderly and the increasing proportion of elderly adults underscores the population's attributable risk of anemia. As a potentially modifiable factor, an urgent need exists to delineate the impact of anemia correction in the elderly. The Partnership for Anemia: Clinical and Translational Trials in the Elderly (PACTTE) consortium has been created to focus on treatment strategies for anemia in elderly patients. The data presented in this protocol provides a compelling rationale to evaluate the impact of a well-tolerated IV iron preparation in community dwelling older anemic adults with intermediate serum ferritin values.

Subjects will be 65 years or older adults with unexplained anemia and a serum ferritin between 20 and 200 ng/mL.

Subjects will be randomized on a 1:1 basis to either receive a 5 week course of treatment with intravenous iron immediately or to a waitlist control group who will receive treatment with intravenous iron following a 12 week observation period. Both groups will ultimately receive 200mg of intravenous iron sucrose weekly for 5 weeks to determine if this can lead to improvement in 6 Minute Walk Test results. The primary endpoint is change in 6 Minute Walk Test distances from baseline to 12 weeks. The procedures in this protocol will include the use of outcomes tools that have been selected for their ability to show improvement in quality of life in this patient population. Blood samples will also be collected for analysis both at the local lab (safety tests - eg hemoglobin or Hb) or at a central lab for research purposes.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years old
* Hemoglobin concentration ≥ 9.0 g/dL and \< 11.5 g/dL (women) or \< 12.7 g/dL (men)
* Unexplained anemia
* Serum ferritin level ≥ 20 and ≤ 200 ng/mL
* Able to walk without the use of a walker, motorized device or the assistance of another person.
* Able to understand and willing to provide written informed consent in the absence of dementia
* Must be able to understand and speak in English

Exclusion Criteria:

* Red blood cell transfusions within the past 3 months
* Use of erythropoiesis stimulating agents (ESA) in the past 3 months
* Intravenous Iron Infusions within the past 3 months
* Distance on baseline 6MWT (6 minute walk test) above the median for age and sex
* History of unstable angina or myocardial infarction in the past 3 months
* History of stroke or TIA (transient ischemic attack) the past 3 months
* Uncontrolled hypertension (diastolic blood pressure \> 100 mm Hg or systolic blood pressure \> 160 mm Hg on 2 separate occasions)
* Positive fecal occult blood test within the screening period
* Elevated AST (aspartate aminotransferase) or ALT (alanine aminotransferase) ≥ 2x upper limit of normal
* Documented anaphylactic reaction to iron sucrose infusion in the past
* 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 gram/dL improvement in Hb since starting oral iron supplementation

Primary outcomes:
measure: Change in 6 Minute Walk Test Results
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Number of Participants Who Had a Hemoglobin Increase >= 1g/dL
timeFrame: baseline, 12 weeks
measure: Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B
timeFrame: Baseline, 12 weeks
measure: Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)
timeFrame: Baseline, 12 weeks
measure: Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)
timeFrame: baseline, 12 weeks
measure: Change in Frailty Component Related to Fatigue/ Exhaustion
timeFrame: baseline, 12 weeks
measure: Change in Cognitive Outcome Measures as Determined by Speed of Processing
timeFrame: Baseline, 12 Week
measure: Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing
timeFrame: Baseline, 12 week
measure: Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory
timeFrame: Baseline, 12 week
measure: Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score
timeFrame: Baseline, 12 weeks
measure: Change in the Frailty Component as Determined by Self-reported Activity Level
timeFrame: Baseline, 12 week
measure: Change in Frailty Component as Determined by Grip Strength
timeFrame: Baseline, 12 weeks
measure: Change in Frailty Component as Determined by the 4 Meter Walk Speed
timeFrame: Baseline, 12 weeks
measure: Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks
timeFrame: baseline, 12 weeks
measure: Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin
timeFrame: baseline, 12 weeks
measure: Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance
timeFrame: baseline, 12 weeks
measure: Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance
timeFrame: baseline, 12 weeks
measure: Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance
timeFrame: baseline, 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois, Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University Geriatrics Center
state: Maryland
city: Cleveland
country: United States
facility: Case Western Reserve University Medical Center
state: Ohio
city: Falls Church
country: United States
facility: Institute For Advanced Studies in Aging
state: Virginia
Study officials:
affiliation: Stanford University MC
name: Elizabeth Price, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Stanley Schrier, MD
role: STUDY_CHAIR
affiliation: University of Chicago
name: Andrew Artz, MD
role: PRINCIPAL_INVESTIGATOR
References: