Trial Outcomes & Findings for Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia (NCT NCT01309659)

Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia

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.

To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12.

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.

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 HB from baseline to 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.

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.

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.

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.

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.

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.

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.

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 hemoglobin from the baseline to 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 from baseline to 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 from baseline to 12 weeks