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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Change in 6 Minute Walk Test Results
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Immediate Intervention Group
Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.
干预措施: iron sucrose (Drug)
Wait List Control
Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up
干预措施: iron sucrose (Drug)
结局指标
主要结局
Change in 6 Minute Walk Test Results
时间窗: Baseline, 12 weeks
Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented.
次要结局
- Number of Participants Who Had a Hemoglobin Increase >= 1g/dL(baseline, 12 weeks)
- Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B(Baseline, 12 weeks)
- Change in Frailty Component as Determined by the 4 Meter Walk Speed(Baseline, 12 weeks)
- Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance(baseline, 12 weeks)
- Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance(baseline, 12 weeks)
- Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)(Baseline, 12 weeks)
- Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory(Baseline, 12 week)
- Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks(baseline, 12 weeks)
- Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin(baseline, 12 weeks)
- Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance(baseline, 12 weeks)
- Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)(baseline, 12 weeks)
- Change in Frailty Component Related to Fatigue/ Exhaustion(baseline, 12 weeks)
- Change in Cognitive Outcome Measures as Determined by Speed of Processing(Baseline, 12 Week)
- Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score(Baseline, 12 weeks)
- Change in the Frailty Component as Determined by Self-reported Activity Level(Baseline, 12 week)
- Change in Frailty Component as Determined by Grip Strength(Baseline, 12 weeks)
- Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing(Baseline, 12 week)