| ID | Type | Description | Link |
|---|---|---|---|
| U01AG034661 | U.S. NIH Grant/Contract | View source | |
| PACTTE_01 |
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Lack of Enrollment
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Group | Experimental | 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. |
|
| Wait List Control | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iron sucrose | Drug | Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 12 weeks |
| Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Price, MD | Stanford University MC | Principal Investigator |
| Stanley Schrier, MD | Stanford University | Study Chair |
| Andrew Artz, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois, Chicago | Chicago | Illinois | 60612 | United States | ||
| University of Chicago Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. | Posted | Mean | Standard Deviation | meters | Baseline, 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations |
Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harvey J Cohen, MD | Duke University Medical Center | 919-660-7502 | harvey.cohen@dm.duke.edu |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
Not provided
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|
| iron sucrose | Drug | 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. |
|
|
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. |
| Baseline, 12 weeks |
| 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. | Baseline, 12 weeks |
| 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. | baseline, 12 weeks |
| 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:
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. | baseline, 12 weeks |
| 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. | Baseline, 12 Week |
| 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. | Baseline, 12 week |
| 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. | Baseline, 12 week |
| 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. | Baseline, 12 weeks |
| 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. | Baseline, 12 week |
| 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. | Baseline, 12 weeks |
| 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. | Baseline, 12 weeks |
| 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. | baseline, 12 weeks |
| 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. | baseline, 12 weeks |
| 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. | baseline, 12 weeks |
| 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 | baseline, 12 weeks |
| 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 | baseline, 12 weeks |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Johns Hopkins University Geriatrics Center | Baltimore | Maryland | 21224 | United States |
| Case Western Reserve University Medical Center | Cleveland | Ohio | 44106 | United States |
| Institute For Advanced Studies in Aging | Falls Church | Virginia | 22042 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| hemoglobin | Mean | Standard Deviation | g/dl |
|
| OG001 | 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. |
|
|
| 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. | Posted | Number | participants | baseline, 12 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | change in seconds per completed circle | Baseline, 12 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | t score | Baseline, 12 weeks |
|
|
|
| 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. | All intent-to-treat patients were included in the primary analysis with an assumption that any missing data were missing completely at random. | Posted | Number | correlation coefficient | baseline, 12 weeks |
|
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|
|
| 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:
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. | 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. | Posted | Number | participants | baseline, 12 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | change in Z-Score | Baseline, 12 Week |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | change in Z-score | Baseline, 12 week |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | change in Z-score | Baseline, 12 week |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | change in the total score | Baseline, 12 weeks |
|
|
|
| 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. | 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. | Posted | Number | participants | Baseline, 12 week |
|
|
|
| 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. | 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. | Posted | Number | participants | Baseline, 12 weeks |
|
|
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| 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. | 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. | Posted | Number | participants | Baseline, 12 weeks |
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| 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. | 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. | Posted | Number | correlation coefficient | baseline, 12 weeks |
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| 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. | 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. | Posted | Number | correlation coefficient | baseline, 12 weeks |
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| 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. | 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. | Posted | Number | correlation coefficient | baseline, 12 weeks |
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| 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 | 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. | Posted | Number | correlation coefficient | baseline, 12 weeks |
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| 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 | 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. | Posted | Number | correlation coefficient | baseline, 12 weeks |
|
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|
|
| 1 |
| 9 |
| 7 |
| 9 |
| EG001 | 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. | 1 | 10 | 5 | 10 |
| Escherichia urinary tract infection | Infections and infestations |
|
| Pelvic Fracture | Injury, poisoning and procedural complications |
|
| Syncope | Nervous system disorders |
|
| Gastrointestinal infection | Infections and infestations |
|
| Urinary tract infecction | Infections and infestations |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Joint swelling | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Feeling hot | General disorders |
|
| Infusion site bruising | General disorders |
|
| Spinal Pain | General disorders |
|
| Arthropod sting | Injury, poisoning and procedural complications |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Liver function test abnormal | Investigations |
|
| Anxiety | Psychiatric disorders |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders |
|
| Orthostatic hypotension | Vascular disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
Not provided
Not provided
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| Correlation btw baseline TST & change in Hgb |
|
| 0.601 |
Correlation between ferritin and change in hemoglobin in the waitlist group. Testing the correlation = 0. |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.396 | Correlation between iron and change in hemoglobin in the intermediate intervention group. Testing the correlation = 0. | 2-Sided | No | Superiority or Other |
| t-test, 2 sided | 0.106 | Correlation between iron and change in hemoglobin in the waitlist group. Testing the correlation = 0. | 2-Sided | No | Superiority or Other |
| t-test, 2 sided | 0.606 | Correlation between transferrin saturation and change in hemoglobin in the immediate intervention group. Testing the correlation = 0. | 2-Sided | No | Superiority or Other |
| t-test, 2 sided | 0.077 | Correlation between transferrin saturation and change in hemoglobin in the waitlist group. Testing the correlation = 0. | 2-Sided | No | Superiority or Other |
| 0.001 |
Correlation between soluble transfer receptor and change in hemoglobin in the wait list group. Testing the correlation =0. |
| 2-Sided |
| No |
| Superiority or Other |
| 0.111 |
Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the wait list control group. Testing correlation =0. |
| 2-Sided |
| No |
| Superiority or Other |
| Correlation TSAT |
|
| 0.798 |
Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0. |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | 0.383 | Correlation between baseline iron and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0. | 2-Sided | No | Superiority or Other |
| t-test, 2 sided | 0.732 | Correlation between baseline iron and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0. | 2-Sided | No | Superiority or Other |
| t-test, 2 sided | 0.286 | Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0. | 2-Sided | No | Superiority or Other |
| t-test, 2 sided | 0.356 | Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0. | 2-Sided | No | Superiority or Other |
| 0.396 |
Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the wait list group. Testing correlation =0. |
| 2-Sided |
| No |
| Superiority or Other |
| 0.329 |
Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the wait list group. Testing correlation =0. |
| 2-Sided |
| No |
| Superiority or Other |