Anemia, Chronic Kidney Disease
Conditions
Keywords
Anemia, Chronic Kidney Disease, Quality of Life, CKD, Chronic Renal Insufficiency
Brief summary
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.
Detailed description
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.
Interventions
OTHERObservations
This is a non-interventional, observational study; no investigational product is being used
Sponsors
Amgen
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 65 years * Long-term resident of NH as documented in medical record by Director of Nursing (DON) or Medical Director or as indicated in Minimum Data Set (MDS) Section Q * Able to walk at least 1 step or propel wheelchair 1 revolution of wheel * Able to follow a one-step instruction * Written informed consent
Exclusion criteria
* Admitted to NH for short stay rehabilitation (anticipated stay less than 3 months) * Receiving Renal Replacement Therapy (RRT) * Major surgery within the past 3 months * Life expectancy \< 6 months or receiving palliative care * Currently enrolled in or has not yet completed at least 30 days since ending investigational device or drug study(s), or is receiving investigational agent(s) * Currently is enrolled in an interventional trial * Previously withdrawn from this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Weeks 2, 14 and 26 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Anemia Related Conditions at Baseline | 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. |
| Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Weeks 1, 14 and 26 | 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). |
| Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Weeks 2, 14 and 26 | 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. |
| Physical Performance: Duration Walked or Wheeled at Each Visit | Weeks 2, 14, 26 | The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes. |
| Number of Participants With Anemia | Baseline | Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men. |
| Physical Performance: Grip Strength | Weeks 2, 14, 26 | 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. |
| Physical Performance: Lower Extremity Strength, Left Leg. | Weeks 2, 14, 26 | 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. |
| Physical Performance: Lower Extremity Strength, Right Leg | Weeks 2, 14, 26 | 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. |
| Physical Performance: Time to Rise From Sitting to Standing | Weeks 2, 14, 26 | 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. |
Participant flow
Pre-assignment details
815 patients were enrolled; 21 of these could not be classified into the defined groups because of missing lab values at enrollment. Their anemic/CKD status is therefore not available.
Participants by arm
| Arm | Count |
|---|---|
| No CKD, But Anemia 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. | 169 |
| No CKD or Anemia 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. | 232 |
| CKD With Anemia 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. | 228 |
| CKD With no Anemia 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. | 165 |
| Total | 794 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | AE not leading to hospitalization | 0 | 0 | 2 | 0 |
| Overall Study | Death | 0 | 19 | 5 | 1 |
| Overall Study | Dismissed from nursing home | 0 | 9 | 5 | 0 |
| Overall Study | Hospitalization | 0 | 1 | 0 | 1 |
| Overall Study | Ineligibility determined | 1 | 1 | 1 | 0 |
| Overall Study | Other | 0 | 4 | 6 | 0 |
| Overall Study | Physician Decision | 0 | 5 | 0 | 0 |
| Overall Study | Subject Non Compliance | 0 | 6 | 0 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 10 | 11 | 0 |
Baseline characteristics
| Characteristic | No CKD, But Anemia | No CKD or Anemia | CKD With Anemia | CKD With no Anemia | Total |
|---|---|---|---|---|---|
| Age, Continuous | 82.6 Years STANDARD_DEVIATION 8.3 | 81.6 Years STANDARD_DEVIATION 8.2 | 84.6 Years STANDARD_DEVIATION 8.1 | 83.8 Years STANDARD_DEVIATION 8.4 | 83.1 Years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 88 Participants | 172 Participants | 159 Participants | 139 Participants | 558 Participants |
| Sex: Female, Male Male | 81 Participants | 60 Participants | 69 Participants | 26 Participants | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: Enrolled patients with CKD and non-missing data at each time point (indicated by N).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CKD With Anemia | Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 2 (N=209, 152) | 210.0 feet |
| CKD With Anemia | Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 14 (N=173, 134) | 210.0 feet |
| CKD With Anemia | Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 26 (N=158, 124) | 185.0 feet |
| CKD With no Anemia | Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 14 (N=173, 134) | 246.5 feet |
| CKD With no Anemia | Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 2 (N=209, 152) | 253.1 feet |
| CKD With no Anemia | Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 26 (N=158, 124) | 198.5 feet |
Secondary
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
Population: Enrolled patients with CKD and non-missing data at each time point (indicated by N).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CKD With Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 1 - MDRD (N=228, 165) | 42.1 mL/min/1.73 m^2 | Standard Deviation 10.6 |
| CKD With Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 26 - MDRD (N=169, 132) | 45.2 mL/min/1.73 m^2 | Standard Deviation 15.3 |
| CKD With Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 26 - CG (N=167, 132) | 37.4 mL/min/1.73 m^2 | Standard Deviation 15.6 |
| CKD With Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 1 - CG (N=224, 165) | 35.0 mL/min/1.73 m^2 | Standard Deviation 13.9 |
| CKD With Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 14 - MDRD (N=183, 143) | 42.6 mL/min/1.73 m^2 | Standard Deviation 11.6 |
| CKD With Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 14 - CG (N=181, 143) | 35.9 mL/min/1.73 m^2 | Standard Deviation 15.2 |
| CKD With no Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 14 - MDRD (N=183, 143) | 48.0 mL/min/1.73 m^2 | Standard Deviation 15 |
| CKD With no Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 26 - CG (N=167, 132) | 41.8 mL/min/1.73 m^2 | Standard Deviation 16.8 |
| CKD With no Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 1 - MDRD (N=228, 165) | 44.9 mL/min/1.73 m^2 | Standard Deviation 9.9 |
| CKD With no Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 14 - CG (N=181, 143) | 41.6 mL/min/1.73 m^2 | Standard Deviation 16.9 |
| CKD With no Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 26 - MDRD (N=169, 132) | 48.0 mL/min/1.73 m^2 | Standard Deviation 13.5 |
| CKD With no Anemia | Estimated Glomerular Filtration Rate (GFR) for Participants With CKD | Week 1 - CG (N=224, 165) | 39.6 mL/min/1.73 m^2 | Standard Deviation 15.7 |
Secondary
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
Population: All enrolled patients with available anemia lab results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CKD With Anemia | Number of Participants With Anemia | 397 participants |
Secondary
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
Population: Enrolled patients with anemia
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CKD With Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Vitamin B12 deficiency | 2.6 Percentage of participants |
| CKD With Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Chronic inflammation | 21.9 Percentage of participants |
| CKD With Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Gastrointestinal (GI) Bleed | 11.4 Percentage of participants |
| CKD With Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Folate deficiency | 2.2 Percentage of participants |
| CKD With Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Iron deficiency | 0.0 Percentage of participants |
| CKD With no Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Folate deficiency | 4.1 Percentage of participants |
| CKD With no Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Iron deficiency | 0.0 Percentage of participants |
| CKD With no Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Vitamin B12 deficiency | 5.3 Percentage of participants |
| CKD With no Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Gastrointestinal (GI) Bleed | 10.1 Percentage of participants |
| CKD With no Anemia | Percentage of Participants With Anemia Related Conditions at Baseline | Chronic inflammation | 18.3 Percentage of participants |
Secondary
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
Population: Enrolled patients with CKD and non-missing data at each time point (indicated by N).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CKD With Anemia | Physical Performance: Duration Walked or Wheeled at Each Visit | Week 2 (N=208, 152) | 6.4 minutes | Standard Deviation 3.3 |
| CKD With Anemia | Physical Performance: Duration Walked or Wheeled at Each Visit | Week 14 (N=173, 133) | 6.5 minutes | Standard Deviation 3.1 |
| CKD With Anemia | Physical Performance: Duration Walked or Wheeled at Each Visit | Week 26 (N=158, 124) | 6.6 minutes | Standard Deviation 3.1 |
| CKD With no Anemia | Physical Performance: Duration Walked or Wheeled at Each Visit | Week 2 (N=208, 152) | 6.2 minutes | Standard Deviation 3.1 |
| CKD With no Anemia | Physical Performance: Duration Walked or Wheeled at Each Visit | Week 14 (N=173, 133) | 6.4 minutes | Standard Deviation 3.2 |
| CKD With no Anemia | Physical Performance: Duration Walked or Wheeled at Each Visit | Week 26 (N=158, 124) | 6.0 minutes | Standard Deviation 3.2 |
Secondary
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
Population: Enrolled patients with CKD and non-missing data at each time point (indicated by N).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CKD With Anemia | Physical Performance: Grip Strength | Week 2 (N=215, 154) | 29.6 pound-force | Standard Deviation 17.4 |
| CKD With Anemia | Physical Performance: Grip Strength | Week 14 (N=182, 140) | 29.8 pound-force | Standard Deviation 17.3 |
| CKD With Anemia | Physical Performance: Grip Strength | Week 26 (N=166, 129) | 29.0 pound-force | Standard Deviation 16.9 |
| CKD With no Anemia | Physical Performance: Grip Strength | Week 2 (N=215, 154) | 31.8 pound-force | Standard Deviation 16.9 |
| CKD With no Anemia | Physical Performance: Grip Strength | Week 14 (N=182, 140) | 32.5 pound-force | Standard Deviation 17.1 |
| CKD With no Anemia | Physical Performance: Grip Strength | Week 26 (N=166, 129) | 29.8 pound-force | Standard Deviation 17.4 |
Secondary
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
Population: Enrolled patients with CKD and non-missing data at each time point (indicated by N).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CKD With Anemia | Physical Performance: Lower Extremity Strength, Left Leg. | Week 2 (N=211, 151) | 5.3 pounds | Standard Deviation 4.1 |
| CKD With Anemia | Physical Performance: Lower Extremity Strength, Left Leg. | Week 14 (N=174, 136) | 5.3 pounds | Standard Deviation 4.4 |
| CKD With Anemia | Physical Performance: Lower Extremity Strength, Left Leg. | Week 26 (N=159, 125) | 5.6 pounds | Standard Deviation 4.5 |
| CKD With no Anemia | Physical Performance: Lower Extremity Strength, Left Leg. | Week 2 (N=211, 151) | 6.1 pounds | Standard Deviation 4.1 |
| CKD With no Anemia | Physical Performance: Lower Extremity Strength, Left Leg. | Week 14 (N=174, 136) | 6.6 pounds | Standard Deviation 4.6 |
| CKD With no Anemia | Physical Performance: Lower Extremity Strength, Left Leg. | Week 26 (N=159, 125) | 6.4 pounds | Standard Deviation 4.5 |
Secondary
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
Population: Enrolled patients with CKD and non-missing data at each time point (indicated by N).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CKD With Anemia | Physical Performance: Lower Extremity Strength, Right Leg | Week 2 (N= 212, 151) | 5.3 pounds | Standard Deviation 4 |
| CKD With Anemia | Physical Performance: Lower Extremity Strength, Right Leg | Week 14 (N=174, 136) | 5.2 pounds | Standard Deviation 4 |
| CKD With Anemia | Physical Performance: Lower Extremity Strength, Right Leg | Week 26 (N=159, 125) | 5.6 pounds | Standard Deviation 4.5 |
| CKD With no Anemia | Physical Performance: Lower Extremity Strength, Right Leg | Week 26 (N=159, 125) | 6.5 pounds | Standard Deviation 4.5 |
| CKD With no Anemia | Physical Performance: Lower Extremity Strength, Right Leg | Week 2 (N= 212, 151) | 6.3 pounds | Standard Deviation 4 |
| CKD With no Anemia | Physical Performance: Lower Extremity Strength, Right Leg | Week 14 (N=174, 136) | 6.1 pounds | Standard Deviation 4.1 |
Secondary
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
Population: Enrolled patients with CKD and non-missing data at each time point (indicated by N).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CKD With Anemia | Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 2 (N=208, 152) | 51.2 feet per minute | Standard Deviation 40.4 |
| CKD With Anemia | Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 14 (N=172, 132) | 51.0 feet per minute | Standard Deviation 41.6 |
| CKD With Anemia | Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 26 (N=158, 123) | 49.9 feet per minute | Standard Deviation 42.2 |
| CKD With no Anemia | Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 2 (N=208, 152) | 61.9 feet per minute | Standard Deviation 51.4 |
| CKD With no Anemia | Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 14 (N=172, 132) | 70.1 feet per minute | Standard Deviation 59 |
| CKD With no Anemia | Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit | Week 26 (N=158, 123) | 66.5 feet per minute | Standard Deviation 62.3 |
Secondary
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
Population: Enrolled patients with CKD and non-missing data at each time point (indicated by N).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CKD With Anemia | Physical Performance: Time to Rise From Sitting to Standing | Week 2 (N=171, 133) | 3.0 seconds |
| CKD With Anemia | Physical Performance: Time to Rise From Sitting to Standing | Week 14 (N=134, 114) | 2.5 seconds |
| CKD With Anemia | Physical Performance: Time to Rise From Sitting to Standing | Week 26 (N=125, 108) | 3.0 seconds |
| CKD With no Anemia | Physical Performance: Time to Rise From Sitting to Standing | Week 2 (N=171, 133) | 3.0 seconds |
| CKD With no Anemia | Physical Performance: Time to Rise From Sitting to Standing | Week 14 (N=134, 114) | 3.0 seconds |
| CKD With no Anemia | Physical Performance: Time to Rise From Sitting to Standing | Week 26 (N=125, 108) | 3.0 seconds |