Anemia, Unexplained Anemia (UAE)
Conditions
Keywords
Anemia, Unexplained anemia, elderly, geriatric, older adults, UAE, over 65, iron, pactte, pactee, aging, aged, old, older
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.
Interventions
DRUGiron sucrose
Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.
Sponsors
National Institute on Aging (NIA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 Minute Walk Test Results | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B | Baseline, 12 weeks | To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to week 12. |
| Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS) | Baseline, 12 weeks | To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to week 12. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population. |
| Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) | baseline, 12 weeks | Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in HB from baseline to 12 weeks. |
| Change in Frailty Component Related to Fatigue/ Exhaustion | baseline, 12 weeks | Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion: 1. In the past month, on average, have you been feeling unusually tired during the day? is answered yes and indicated as all of the time or most of the time. 2. In the past month, on average, have you felt unusually weak? is answered yes and indicated as all of the time or most of the time. 3. Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL. The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at week 12 as reported by the subject. |
| Change in Cognitive Outcome Measures as Determined by Speed of Processing | Baseline, 12 Week | To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. |
| Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing | Baseline, 12 week | To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test. |
| Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory | Baseline, 12 week | To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Higher numbers indicated a better response.There is no scale, as the results are normalized variables. |
| Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score | Baseline, 12 weeks | To quantify the impact of anemia treatment by IV iron sucrose on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 12 weeks. Scores range from 0-188 with higher scores indicating better function. |
| Number of Participants Who Had a Hemoglobin Increase >= 1g/dL | baseline, 12 weeks | To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12. |
| Change in Frailty Component as Determined by Grip Strength | Baseline, 12 weeks | To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at week 12). Grip strength is stratified by gender and BMI. For men with (BMI \<= 24 and a grip strength (GS) \<= 29) or (BMI 24.1-28 and grip strength \<= 30) or (BMI \>28 and a grip strength \<= 32) were classified as frail. For women with (BMI \<= 23 and a grip strength of \<= 17) or (BMI 23.1-26 and a GS \<= 17.3) or (BMI 26.1-29 and a GS \<= 18) or (BMI \> 29 and a GS \<= 21) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12. |
| Change in Frailty Component as Determined by the 4 Meter Walk Speed | Baseline, 12 weeks | To quantify the impact of anemia treatment by IV iron sucrose on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at week 12). 4 m walking speed is stratified by gender and height. For men, (height of \<= 173 cm and a walking speed of \<= 0.65 meter/sec) or a (height \> 173, \<= .76 meter/sec) were classified as frail. For women, (height of \<= 159 cm and a walking speed of \<=.65 meter/sec) or (height \>159 cm \<= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12. |
| 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 and the change in hemoglobin from the baseline to 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 hemoglobin from baseline to 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 serum ferritin, serum iron, and transferrin saturation and the change in 6 Minute Walk Test distance from baseline to 12 weeks. |
| Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance | baseline, 12 weeks | Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance from baseline to 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 soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance from baseline to 12 weeks |
| Change in the Frailty Component as Determined by Self-reported Activity Level | Baseline, 12 week | To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals \< 128 per week is frail. For women, Kcals \< 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter. | 9 |
| 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
iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter. | 10 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Immediate Intervention Group | Wait List Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 8 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| hemoglobin | 11.19 g/dl STANDARD_DEVIATION 0.64 | 11.3 g/dl STANDARD_DEVIATION 0.8 | 11.25 g/dl STANDARD_DEVIATION 0.71 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 9 Participants |
| Region of Enrollment United States | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 9 | 5 / 10 |
| serious Total, serious adverse events | 1 / 9 | 1 / 10 |
Outcome results
Primary
Change in 6 Minute Walk Test Results
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.
Time frame: Baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in 6 Minute Walk Test Results | 8.05 meters | Standard Deviation 55.48 |
| Wait List Control | Change in 6 Minute Walk Test Results | -11.45 meters | Standard Deviation 49.46 |
Secondary
Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing
To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test.
Time frame: Baseline, 12 week
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Wait List Control did not respond to this during their clinic visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing | 0.36 change in Z-score | Standard Deviation 1.28 |
| Wait List Control | Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing | 0.69 change in Z-score | Standard Deviation 1.19 |
Secondary
Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory
To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Higher numbers indicated a better response.There is no scale, as the results are normalized variables.
Time frame: Baseline, 12 week
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 2 subjects for each of the groups did not have a response for this data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory | 0.41 change in Z-score | Standard Deviation 1.5 |
| Wait List Control | Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory | 1.39 change in Z-score | Standard Deviation 2.36 |
Secondary
Change in Cognitive Outcome Measures as Determined by Speed of Processing
To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.
Time frame: Baseline, 12 Week
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as 1 subject for the Immediate Intervention Group did not respond to this during their clinic visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Cognitive Outcome Measures as Determined by Speed of Processing | 0.62 change in Z-Score | Standard Deviation 1 |
| Wait List Control | Change in Cognitive Outcome Measures as Determined by Speed of Processing | 1.08 change in Z-Score | Standard Deviation 0.88 |
Secondary
Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B
To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to week 12.
Time frame: Baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. The number of participants analyzed is correct as 4 subjects for the wait list control group did not respond to this during their clinic visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B | -0.77 change in seconds per completed circle | Standard Deviation 3.54 |
| Wait List Control | Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B | -4.96 change in seconds per completed circle | Standard Deviation 8.14 |
Secondary
Change in Frailty Component as Determined by Grip Strength
To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at week 12). Grip strength is stratified by gender and BMI. For men with (BMI \<= 24 and a grip strength (GS) \<= 29) or (BMI 24.1-28 and grip strength \<= 30) or (BMI \>28 and a grip strength \<= 32) were classified as frail. For women with (BMI \<= 23 and a grip strength of \<= 17) or (BMI 23.1-26 and a GS \<= 17.3) or (BMI 26.1-29 and a GS \<= 18) or (BMI \> 29 and a GS \<= 21) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12.
Time frame: Baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Three subjects in both the immediate intervention group and the wait list control groups were missing responses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Intervention Group | Change in Frailty Component as Determined by Grip Strength | 0 participants |
| Wait List Control | Change in Frailty Component as Determined by Grip Strength | 0 participants |
Secondary
Change in Frailty Component as Determined by the 4 Meter Walk Speed
To quantify the impact of anemia treatment by IV iron sucrose on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at week 12). 4 m walking speed is stratified by gender and height. For men, (height of \<= 173 cm and a walking speed of \<= 0.65 meter/sec) or a (height \> 173, \<= .76 meter/sec) were classified as frail. For women, (height of \<= 159 cm and a walking speed of \<=.65 meter/sec) or (height \>159 cm \<= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12.
Time frame: Baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Five subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Intervention Group | Change in Frailty Component as Determined by the 4 Meter Walk Speed | 0 participants |
| Wait List Control | Change in Frailty Component as Determined by the 4 Meter Walk Speed | 0 participants |
Secondary
Change in Frailty Component Related to Fatigue/ Exhaustion
Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion: 1. In the past month, on average, have you been feeling unusually tired during the day? is answered yes and indicated as all of the time or most of the time. 2. In the past month, on average, have you felt unusually weak? is answered yes and indicated as all of the time or most of the time. 3. Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL. The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at week 12 as reported by the subject.
Time frame: baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Results reported by number of participants reporting change from their baseline exhaustion, and low energy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immediate Intervention Group | Change in Frailty Component Related to Fatigue/ Exhaustion | Frailty change - self reported exhaustion | 9 participants |
| Immediate Intervention Group | Change in Frailty Component Related to Fatigue/ Exhaustion | Frailty change - self-reported low energy | 0 participants |
| Wait List Control | Change in Frailty Component Related to Fatigue/ Exhaustion | Frailty change - self reported exhaustion | 10 participants |
| Wait List Control | Change in Frailty Component Related to Fatigue/ Exhaustion | Frailty change - self-reported low energy | 0 participants |
Secondary
Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score
To quantify the impact of anemia treatment by IV iron sucrose on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 12 weeks. Scores range from 0-188 with higher scores indicating better function.
Time frame: Baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.The number of participants analyzed is correct as for each of the groups there was missing responses for subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score | 10.6 change in the total score | Standard Deviation 10 |
| Wait List Control | Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score | 0.0 change in the total score | Standard Deviation 34.7 |
Secondary
Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)
To quantify the impact of anemia treatment by IV iron sucrose on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to week 12. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.
Time frame: Baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Number of participants analyzed is correct- 2 subjects for Waitlist Group did not respond.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention Group | Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS) | -1.89 t score | Standard Deviation 2.44 |
| Wait List Control | Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS) | -3.17 t score | Standard Deviation 10.95 |
Secondary
Change in the Frailty Component as Determined by Self-reported Activity Level
To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals \< 128 per week is frail. For women, Kcals \< 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12.
Time frame: Baseline, 12 week
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Two subjects in the immediate intervention group and 5 subjects in the wait list group did not respond.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Intervention Group | Change in the Frailty Component as Determined by Self-reported Activity Level | 0 participants |
| Wait List Control | Change in the Frailty Component as Determined by Self-reported Activity Level | 0 participants |
Secondary
Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance
Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in 6 Minute Walk Test distance from baseline to 12 weeks.
Time frame: baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses from the wait list control group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immediate Intervention Group | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance | Correlation TSAT | 0.400 correlation coefficient |
| Immediate Intervention Group | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance | Correlation for ferritin | 0.617 correlation coefficient |
| Immediate Intervention Group | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance | Correlation for iron | 0.332 correlation coefficient |
| Wait List Control | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance | Correlation for ferritin | 0.100 correlation coefficient |
| Wait List Control | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance | Correlation TSAT | -0.350 correlation coefficient |
| Wait List Control | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance | Correlation for iron | -0.133 correlation coefficient |
p-value: 0.077t-test, 2 sided
p-value: 0.798t-test, 2 sided
p-value: 0.383t-test, 2 sided
p-value: 0.732t-test, 2 sided
p-value: 0.286t-test, 2 sided
p-value: 0.356t-test, 2 sided
Secondary
Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)
Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in HB from baseline to 12 weeks.
Time frame: baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Immediate Intervention Group | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) | Correlation btw baseline ferritin & change in Hgb | 0.383 correlation coefficient |
| Immediate Intervention Group | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) | Correlation btw baseline iron & change in Hgb | 0.323 correlation coefficient |
| Immediate Intervention Group | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) | Correlation btw baseline TST & change in Hgb | 0.200 correlation coefficient |
| Wait List Control | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) | Correlation btw baseline ferritin & change in Hgb | 0.189 correlation coefficient |
| Wait List Control | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) | Correlation btw baseline iron & change in Hgb | 0.541 correlation coefficient |
| Wait List Control | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) | Correlation btw baseline TST & change in Hgb | 0.584 correlation coefficient |
p-value: 0.308t-test, 2 sided
p-value: 0.601t-test, 2 sided
p-value: 0.396t-test, 2 sided
p-value: 0.106t-test, 2 sided
p-value: 0.606t-test, 2 sided
p-value: 0.077t-test, 2 sided
Secondary
Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks
Correlation between baseline soluble transferrin receptor and the change in hemoglobin from the baseline to 12 weeks.
Time frame: baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject in both the immediate intervention and the wait list control groups were missing responses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Intervention Group | Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks | -0.192 correlation coefficient |
| Wait List Control | Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks | -0.886 correlation coefficient |
p-value: 0.649t-test, 2 sided
p-value: 0.001t-test, 2 sided
Secondary
Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance
Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance from baseline to 12 weeks
Time frame: baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. One subject was missing responses in the immediate intervention group and one subject was missing responses in the wait list control group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Intervention Group | Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance | 0.192 correlation coefficient |
| Wait List Control | Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance | 0.349 correlation coefficient |
p-value: 0.649t-test, 2 sided
p-value: 0.396t-test, 2 sided
Secondary
Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin
Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin from baseline to 12 weeks.
Time frame: baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses from both the immediate intervention group and the wait list control group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Intervention Group | Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin | -0.500 correlation coefficient |
| Wait List Control | Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin | -0.714 correlation coefficient |
p-value: 0.391t-test, 2 sided
p-value: 0.111t-test, 2 sided
Secondary
Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance
Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance from baseline to 12 weeks
Time frame: baseline, 12 weeks
Population: All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. Four subjects were missing responses in the immediate intervention group and four subjects were missing responses in the wait list control group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Intervention Group | Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance | -0.300 correlation coefficient |
| Wait List Control | Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance | 0.486 correlation coefficient |
p-value: 0.624t-test, 2 sided
p-value: 0.329t-test, 2 sided
Secondary
Number of Participants Who Had a Hemoglobin Increase >= 1g/dL
To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12.
Time frame: baseline, 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate Intervention Group | Number of Participants Who Had a Hemoglobin Increase >= 1g/dL | 1 participants |
| Wait List Control | Number of Participants Who Had a Hemoglobin Increase >= 1g/dL | 0 participants |