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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No CKD or Anemia | 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. |
| |
| 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. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates. |
| |
| 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. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments. |
| |
| 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. Participants were observed for 26 weeks and completed mobility and physical performance assessments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observations | Other | This is a non-interventional, observational study; no investigational product is being used |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Weeks 2, 14 and 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Percentage of Participants With Anemia Related Conditions at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Older, long-term stay Nursing Home (NH) residents with CKD, with and without anemia
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22568452 | Background | Binder EF, White HK, Resnick B, McClellan WM, Lei L, Ouslander JG. A prospective study of outcomes of nursing home residents with chronic kidney disease with and without anemia. J Am Geriatr Soc. 2012 May;60(5):877-83. doi: 10.1111/j.1532-5415.2012.03941.x. Epub 2012 May 9. | |
| 20129213 | Background | McClellan WM, Resnick B, Lei L, Bradbury BD, Sciarra A, Kewalramani R, Ouslander JG. Prevalence and severity of chronic kidney disease and anemia in the nursing home population. J Am Med Dir Assoc. 2010 Jan;11(1):33-41. doi: 10.1016/j.jamda.2009.07.003. Epub 2009 Nov 6. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | No CKD or Anemia | Chronic kidney disease (CKD) is based on an 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. |
| FG001 | 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. Participants were observed for 26 weeks and completed an anemia work-up, and mobility and physical performance assessments. |
| FG002 | 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. Participants were observed for 26 weeks and completed mobility and physical performance assessments. |
| FG003 | 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. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | No CKD or Anemia |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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). | Enrolled patients with CKD and non-missing data at each time point (indicated by "N"). | Posted | Median | Inter-Quartile Range | feet | Weeks 2, 14 and 26 |
|
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Adverse Events were not collected for this observational protocol.
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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 | 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. |
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21 subjects could not be classified into the defined groups because of missing lab values at enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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N/A (None Retained)
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.
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | Weeks 2, 14, 26 |
| Death |
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| Physician Decision |
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| Withdrawal by Subject |
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| Subject Non Compliance |
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| Dismissed from nursing home |
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| Hospitalization |
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| AE not leading to hospitalization |
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| Other |
|
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.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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. |
|
|
| 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. | All enrolled patients with available anemia lab results. | Posted | Number | participants | Baseline |
|
|
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| 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. | Enrolled patients with anemia | Posted | Number | Percentage of participants | Baseline |
|
|
|
| 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). | Enrolled patients with CKD and non-missing data at each time point (indicated by "N"). | Posted | Mean | Standard Deviation | mL/min/1.73 m^2 | Weeks 1, 14 and 26 |
|
|
|
| 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. | Enrolled patients with CKD and non-missing data at each time point (indicated by "N"). | Posted | Mean | Standard Deviation | feet per minute | Weeks 2, 14 and 26 |
|
|
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| 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. | Enrolled patients with CKD and non-missing data at each time point (indicated by "N"). | Posted | Mean | Standard Deviation | minutes | Weeks 2, 14, 26 |
|
|
|
| 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. | Enrolled patients with CKD and non-missing data at each time point (indicated by "N"). | Posted | Median | Inter-Quartile Range | seconds | Weeks 2, 14, 26 |
|
|
|
| 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. | Enrolled patients with CKD and non-missing data at each time point (indicated by "N"). | Posted | Mean | Standard Deviation | pound-force | Weeks 2, 14, 26 |
|
|
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| 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. | Enrolled patients with CKD and non-missing data at each time point (indicated by "N"). | Posted | Mean | Standard Deviation | pounds | Weeks 2, 14, 26 |
|
|
|
| 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. | Enrolled patients with CKD and non-missing data at each time point (indicated by "N"). | Posted | Mean | Standard Deviation | pounds | Weeks 2, 14, 26 |
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|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 |
| EG003 | 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. Participants completed the study at Week 2 and completed an anemia work-up; data contributed to prevalence estimates. | 0 | 0 | 0 | 0 |
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Gastrointestinal (GI) Bleed |
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| Chronic inflammation |
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| Folate deficiency |
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| Week 26 - MDRD (N=169, 132) |
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| Week 1 - CG (N=224, 165) |
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| Week 14 - CG (N=181, 143) |
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| Week 26 - CG (N=167, 132) |
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| Week 26 (N=158, 123) |
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| Week 26 (N=158, 124) |
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| Week 26 (N=125, 108) |
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| Week 26 (N=166, 129) |
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| Week 26 (N=159, 125) |
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| Week 26 (N=159, 125) |
|