An observational study in Anemia and Chronic Kidney Disease, sponsored by Amgen. Completed. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-25.
Sponsored by Amgen · Observational
This is a prospective, multicenter, observational, hypothesis-generating study exploring mobility, Quality of Life and other physical performance measures among older, long-term stay Nursing Home residents with CKD, with versus without anemia. Enrolled patients will participate in the study up to a total of 26 weeks and be assessed at Weeks 1, 2, 14 and 26/End of Study. Based upon Week 1 hemoglobin and serum creatinine lab results, participants will be categorized into 1 of 4 groups.
Study Design: Multicenter, non-interventional, 26-week, prospective, observational study of older, long-term stay residents with CKD, with and without anemia, in US Nursing Homes.
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This study's enrollment of 815 is above the median of 200 across 331 observational studies indexed under Anemia.
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Older, long-term stay Nursing Home (NH) residents with CKD, with and without anemia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Chronic kidney disease (CKD) is based on estimated Glomerular Filtration Rate (GFR), calculated by the Modification of Diet in Renal Disease (MDRD) method, of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per World Health Organization (WHO) criteria. Participants completed the study after Week 1; data contributed to prevalence estimates.
Other: Observations
CKD is based on estimated GFR calculated by the MDRD method of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per WHO criteria. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates.
Other: Observations
CKD is based on estimated GFR calculated by the MDRD method of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments.
Other: Observations
CKD is based on estimated GFR calculated by the MDRD method of \< 60 mL/min/1.73m\^2. Anemia is defined as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men per WHO criteria. Participants were observed for 26 weeks and completed mobility and physical performance assessments.
Other: Observations
This is a non-interventional, observational study; no investigational product is being used
Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).
Time frame: Weeks 2, 14 and 26
Number of Participants With Anemia
Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men.
Time frame: Baseline
Percentage of Participants With Anemia Related Conditions at Baseline
The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative. Vitamin B12 and folate deficiency based on standard laboratory ranges.
Time frame: Baseline
Estimated Glomerular Filtration Rate (GFR) for Participants With CKD
Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x \[Serum creatinine\]\^-1.154 x \[Age\]\^-0.203 x \[0.742 if patient is female\] x \[1.210 if patient is black\]. 2. Cockcroft-Gault formula: GFR = (140-age) \* (Weight in kg) \* (0.85 if female) / (72 \* Serum Creatinine).
Time frame: Weeks 1, 14 and 26
Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73m\^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.
Time frame: Weeks 2, 14 and 26
Physical Performance: Duration Walked or Wheeled at Each Visit
The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.
Time frame: Weeks 2, 14, 26
Physical Performance: Time to Rise From Sitting to Standing
Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.
Time frame: Weeks 2, 14, 26
Physical Performance: Grip Strength
Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.
Time frame: Weeks 2, 14, 26
Physical Performance: Lower Extremity Strength, Left Leg.
Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.
Time frame: Weeks 2, 14, 26
Physical Performance: Lower Extremity Strength, Right Leg
Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.
Time frame: Weeks 2, 14, 26
| Milestone | No CKD or Anemia | CKD With Anemia | CKD With no Anemia | No CKD, But Anemia |
|---|---|---|---|---|
| Started | 232 | 228 | 165 | 169 |
| Completed | 231 | 173 | 135 | 163 |
| Not completed | 1 | 55 | 30 | 6 |
| Withdrew: Ineligibility determined | 1 | 1 | 1 | 0 |
| Withdrew: Death | 0 | 19 | 5 | 1 |
| Withdrew: Physician decision | 0 | 5 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 10 | 11 | 0 |
| Withdrew: Subject non compliance | 0 | 6 | 0 | 4 |
| Withdrew: Dismissed from nursing home | 0 | 9 | 5 | 0 |
| Withdrew: Hospitalization | 0 | 1 | 0 | 1 |
| Withdrew: Ae not leading to hospitalization | 0 | 0 | 2 | 0 |
| Withdrew: Other | 0 | 4 | 6 | 0 |
The distance a participant walked, with or without an assistive device and stand-by assistance of 1 person, or propelled him/herself in a wheelchair with or without the use of his/her feet, over level ground, during a period of up to 10 minutes including up to two 30-second rest periods (at weeks 2, 14 and 26).
| feet | CKD With Anemia | CKD With no Anemia |
|---|---|---|
| Week 2 (N=209, 152) | 210.0 (83.4 to 540.0) | 253.1 (91.8 to 540.0) |
| Week 14 (N=173, 134) | 210.0 (79.3 to 500.0) | 246.5 (108.0 to 680.0) |
| Week 26 (N=158, 124) | 185.0 (87.3 to 450.0) | 198.5 (99.0 to 497.3) |
Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men.
| participants | All Enrolled Participants |
|---|---|
| Number of Participants With Anemia | 397 |
The percentages of anemic subjects with iron deficiency, vitamin B12 deficiency, gastrointestinal (GI) bleed, chronic inflammation, and folate deficiency. Anemia of iron deficiency is defined as reduced serum iron, reduced transferrin saturation, ferritin less than 12 ng/mL plus increased Total Iron Binding Capacity (TIBC), per normal laboratory range. Anemia of chronic inflammation defined as reduced serum iron and transferrin saturation, increased or normal ferritin, and reduced or normal TIBC. GI bleed is based on the result of the stool guaiac sample(s) collected: A participant is considered to have GI bleed if one guaiac sample is positive, and not to have GI bleed only if all of his/her three stool guaiac samples were negative. Vitamin B12 and folate deficiency based on standard laboratory ranges.
| Percentage of participants | CKD With Anemia | No CKD But Anemia |
|---|---|---|
| Iron deficiency | 0.0 | 0.0 |
| Vitamin B12 deficiency | 2.6 | 5.3 |
| Gastrointestinal (GI) Bleed | 11.4 | 10.1 |
| Chronic inflammation | 21.9 | 18.3 |
| Folate deficiency | 2.2 | 4.1 |
Estimated GFR measures how much blood the kidneys are filtering, and was calculated using 2 methods: 1. Modification of Diet in Renal Disease study (MDRD) formula: estimated GFR = 186 x \[Serum creatinine\]\^-1.154 x \[Age\]\^-0.203 x \[0.742 if patient is female\] x \[1.210 if patient is black\]. 2. Cockcroft-Gault formula: GFR = (140-age) \* (Weight in kg) \* (0.85 if female) / (72 \* Serum Creatinine).
| mL/min/1.73 m^2 | CKD With Anemia | CKD With no Anemia |
|---|---|---|
| Week 1 - MDRD (N=228, 165) | 42.1 ± 10.6 | 44.9 ± 9.9 |
| Week 14 - MDRD (N=183, 143) | 42.6 ± 11.6 | 48.0 ± 15.0 |
| Week 26 - MDRD (N=169, 132) | 45.2 ± 15.3 | 48.0 ± 13.5 |
| Week 1 - CG (N=224, 165) | 35.0 ± 13.9 | 39.6 ± 15.7 |
| Week 14 - CG (N=181, 143) | 35.9 ± 15.2 | 41.6 ± 16.9 |
| Week 26 - CG (N=167, 132) | 37.4 ± 15.6 | 41.8 ± 16.8 |
Physical performance was measured for all patients with CKD (defined as estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73m\^2). The average speed a participant walked, with or without an assistive device, and stand-by assistance of one person or propelled themselves in their wheelchair with or without the use of their feet, over level ground, up to 10 minutes with up to two 30 second rest periods.
| feet per minute | CKD With Anemia | CKD With no Anemia |
|---|---|---|
| Week 2 (N=208, 152) | 51.2 ± 40.4 | 61.9 ± 51.4 |
| Week 14 (N=172, 132) | 51.0 ± 41.6 | 70.1 ± 59.0 |
| Week 26 (N=158, 123) | 49.9 ± 42.2 | 66.5 ± 62.3 |
The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.
| minutes | CKD With Anemia | CKD With no Anemia |
|---|---|---|
| Week 2 (N=208, 152) | 6.4 ± 3.3 | 6.2 ± 3.1 |
| Week 14 (N=173, 133) | 6.5 ± 3.1 | 6.4 ± 3.2 |
| Week 26 (N=158, 124) | 6.6 ± 3.1 | 6.0 ± 3.2 |
Participants were asked to stand from a seated position so that knees approximated full extension. Timing began from the point that the participant initiated the standing behavior to the point he/she was on his/her feet with knees at approximately full extension.
| seconds | CKD With Anemia | CKD With no Anemia |
|---|---|---|
| Week 2 (N=171, 133) | 3.0 (2.0 to 6.0) | 3.0 (2.0 to 6.0) |
| Week 14 (N=134, 114) | 2.5 (1.5 to 5.8) | 3.0 (1.7 to 5.0) |
| Week 26 (N=125, 108) | 3.0 (1.2 to 6.0) | 3.0 (1.5 to 4.6) |
Grip strength was measured using an adjustable, hand-held, hydraulic grip strength dynamometer. While seated, participants were asked to grip the 2 bars of the dynamometer in their hand and slowly squeeze as hard as they can; then relax. The highest of three measurements was recorded.
| pound-force | CKD With Anemia | CKD With no Anemia |
|---|---|---|
| Week 2 (N=215, 154) | 29.6 ± 17.4 | 31.8 ± 16.9 |
| Week 14 (N=182, 140) | 29.8 ± 17.3 | 32.5 ± 17.1 |
| Week 26 (N=166, 129) | 29.0 ± 16.9 | 29.8 ± 17.4 |
Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.
| pounds | CKD With Anemia | CKD With no Anemia |
|---|---|---|
| Week 2 (N=211, 151) | 5.3 ± 4.1 | 6.1 ± 4.1 |
| Week 14 (N=174, 136) | 5.3 ± 4.4 | 6.6 ± 4.6 |
| Week 26 (N=159, 125) | 5.6 ± 4.5 | 6.4 ± 4.5 |
Lower extremity strength test measures the maximum amount of weight a participant can lift one time throughout his/her range of motion. While supine, and using adjustable cuff weights, participants were asked to bend at their hip and knee and draw their heel along the bed towards their buttocks.
| pounds | CKD With Anemia | CKD With no Anemia |
|---|---|---|
| Week 2 (N= 212, 151) | 5.3 ± 4.0 | 6.3 ± 4.0 |
| Week 14 (N=174, 136) | 5.2 ± 4.0 | 6.1 ± 4.1 |
| Week 26 (N=159, 125) | 5.6 ± 4.5 | 6.5 ± 4.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No CKD or Anemia | — | — | — |
| CKD With Anemia | — | — | — |
| CKD With no Anemia | — | — | — |
| No CKD, But Anemia | — | — | — |
| Age, Continuous(Years) | No CKD, But Anemia | No CKD or Anemia | CKD With Anemia | CKD With no Anemia | Total |
|---|---|---|---|---|---|
| Mean | 82.6 ± 8.3 | 81.6 ± 8.2 | 84.6 ± 8.1 | 83.8 ± 8.4 | 83.1 ± 8.3 |
| Sex: Female, Male(Participants) | No CKD, But Anemia | No CKD or Anemia | CKD With Anemia | CKD With no Anemia | Total |
|---|---|---|---|---|---|
| Female | 88 | 172 | 159 | 139 | 558 |
| Male | 81 | 60 | 69 | 26 | 236 |
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