Trial Outcomes & Findings for LEARN-6™: A Prospective, Observational Nursing Home Study (NCT NCT00727571)
NCT ID: NCT00727571
Last Updated: 2014-07-25
Results Overview
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).
COMPLETED
815 participants
Weeks 2, 14 and 26
2014-07-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
232
|
228
|
165
|
169
|
|
Overall Study
COMPLETED
|
231
|
173
|
135
|
163
|
|
Overall Study
NOT COMPLETED
|
1
|
55
|
30
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Ineligibility determined
|
1
|
1
|
1
|
0
|
|
Overall Study
Death
|
0
|
19
|
5
|
1
|
|
Overall Study
Physician Decision
|
0
|
5
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
10
|
11
|
0
|
|
Overall Study
Subject Non Compliance
|
0
|
6
|
0
|
4
|
|
Overall Study
Dismissed from nursing home
|
0
|
9
|
5
|
0
|
|
Overall Study
Hospitalization
|
0
|
1
|
0
|
1
|
|
Overall Study
AE not leading to hospitalization
|
0
|
0
|
2
|
0
|
|
Overall Study
Other
|
0
|
4
|
6
|
0
|
Baseline Characteristics
LEARN-6™: A Prospective, Observational Nursing Home Study
Baseline characteristics by cohort
| Measure |
No CKD, But Anemia
n=169 Participants
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.
|
No CKD or Anemia
n=232 Participants
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.
|
CKD With Anemia
n=228 Participants
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.
|
CKD With no Anemia
n=165 Participants
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.
|
Total
n=794 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
82.6 Years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
81.6 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
84.6 Years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
83.8 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
83.1 Years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
558 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
236 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Weeks 2, 14 and 26Population: Enrolled patients with CKD and non-missing data at each time point (indicated by "N").
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).
Outcome measures
| Measure |
CKD With Anemia
n=209 Participants
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.
|
CKD With no Anemia
n=152 Participants
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.
|
|---|---|---|
|
Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
Week 2 (N=209, 152)
|
210.0 feet
Interval 83.4 to 540.0
|
253.1 feet
Interval 91.8 to 540.0
|
|
Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
Week 14 (N=173, 134)
|
210.0 feet
Interval 79.3 to 500.0
|
246.5 feet
Interval 108.0 to 680.0
|
|
Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit
Week 26 (N=158, 124)
|
185.0 feet
Interval 87.3 to 450.0
|
198.5 feet
Interval 99.0 to 497.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled patients with available anemia lab results.
Anemia is defined using World Health Organization (WHO) criteria as Hemogloblin \<12 g/dL in women, \< 13 g/dL in men.
Outcome measures
| Measure |
CKD With Anemia
n=794 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants With Anemia
|
397 participants
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Enrolled patients with anemia
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.
Outcome measures
| Measure |
CKD With Anemia
n=228 Participants
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.
|
CKD With no Anemia
n=169 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Anemia Related Conditions at Baseline
Iron deficiency
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Anemia Related Conditions at Baseline
Vitamin B12 deficiency
|
2.6 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Participants With Anemia Related Conditions at Baseline
Gastrointestinal (GI) Bleed
|
11.4 Percentage of participants
|
10.1 Percentage of participants
|
|
Percentage of Participants With Anemia Related Conditions at Baseline
Chronic inflammation
|
21.9 Percentage of participants
|
18.3 Percentage of participants
|
|
Percentage of Participants With Anemia Related Conditions at Baseline
Folate deficiency
|
2.2 Percentage of participants
|
4.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 14 and 26Population: Enrolled patients with CKD and non-missing data at each time point (indicated by "N").
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).
Outcome measures
| Measure |
CKD With Anemia
n=228 Participants
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.
|
CKD With no Anemia
n=165 Participants
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.
|
|---|---|---|
|
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
|
44.9 mL/min/1.73 m^2
Standard Deviation 9.9
|
|
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
|
48.0 mL/min/1.73 m^2
Standard Deviation 15.0
|
|
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
|
48.0 mL/min/1.73 m^2
Standard Deviation 13.5
|
|
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
|
39.6 mL/min/1.73 m^2
Standard Deviation 15.7
|
|
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
|
41.6 mL/min/1.73 m^2
Standard Deviation 16.9
|
|
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
|
41.8 mL/min/1.73 m^2
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: Weeks 2, 14 and 26Population: Enrolled patients with CKD and non-missing data at each time point (indicated by "N").
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.
Outcome measures
| Measure |
CKD With Anemia
n=208 Participants
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.
|
CKD With no Anemia
n=152 Participants
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.
|
|---|---|---|
|
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
|
61.9 feet per minute
Standard Deviation 51.4
|
|
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
|
70.1 feet per minute
Standard Deviation 59.0
|
|
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
|
66.5 feet per minute
Standard Deviation 62.3
|
SECONDARY outcome
Timeframe: Weeks 2, 14, 26Population: Enrolled patients with CKD and non-missing data at each time point (indicated by "N").
The duration a participant was able to walk or propel themselves in a wheelchair during 10 minutes.
Outcome measures
| Measure |
CKD With Anemia
n=208 Participants
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.
|
CKD With no Anemia
n=152 Participants
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.
|
|---|---|---|
|
Physical Performance: Duration Walked or Wheeled at Each Visit
Week 2 (N=208, 152)
|
6.4 minutes
Standard Deviation 3.3
|
6.2 minutes
Standard Deviation 3.1
|
|
Physical Performance: Duration Walked or Wheeled at Each Visit
Week 14 (N=173, 133)
|
6.5 minutes
Standard Deviation 3.1
|
6.4 minutes
Standard Deviation 3.2
|
|
Physical Performance: Duration Walked or Wheeled at Each Visit
Week 26 (N=158, 124)
|
6.6 minutes
Standard Deviation 3.1
|
6.0 minutes
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Weeks 2, 14, 26Population: Enrolled patients with CKD and non-missing data at each time point (indicated by "N").
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.
Outcome measures
| Measure |
CKD With Anemia
n=171 Participants
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.
|
CKD With no Anemia
n=133 Participants
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.
|
|---|---|---|
|
Physical Performance: Time to Rise From Sitting to Standing
Week 2 (N=171, 133)
|
3.0 seconds
Interval 2.0 to 6.0
|
3.0 seconds
Interval 2.0 to 6.0
|
|
Physical Performance: Time to Rise From Sitting to Standing
Week 14 (N=134, 114)
|
2.5 seconds
Interval 1.5 to 5.8
|
3.0 seconds
Interval 1.7 to 5.0
|
|
Physical Performance: Time to Rise From Sitting to Standing
Week 26 (N=125, 108)
|
3.0 seconds
Interval 1.2 to 6.0
|
3.0 seconds
Interval 1.5 to 4.6
|
SECONDARY outcome
Timeframe: Weeks 2, 14, 26Population: Enrolled patients with CKD and non-missing data at each time point (indicated by "N").
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.
Outcome measures
| Measure |
CKD With Anemia
n=215 Participants
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.
|
CKD With no Anemia
n=154 Participants
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.
|
|---|---|---|
|
Physical Performance: Grip Strength
Week 2 (N=215, 154)
|
29.6 pound-force
Standard Deviation 17.4
|
31.8 pound-force
Standard Deviation 16.9
|
|
Physical Performance: Grip Strength
Week 14 (N=182, 140)
|
29.8 pound-force
Standard Deviation 17.3
|
32.5 pound-force
Standard Deviation 17.1
|
|
Physical Performance: Grip Strength
Week 26 (N=166, 129)
|
29.0 pound-force
Standard Deviation 16.9
|
29.8 pound-force
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Weeks 2, 14, 26Population: Enrolled patients with CKD and non-missing data at each time point (indicated by "N").
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.
Outcome measures
| Measure |
CKD With Anemia
n=211 Participants
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.
|
CKD With no Anemia
n=151 Participants
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.
|
|---|---|---|
|
Physical Performance: Lower Extremity Strength, Left Leg.
Week 2 (N=211, 151)
|
5.3 pounds
Standard Deviation 4.1
|
6.1 pounds
Standard Deviation 4.1
|
|
Physical Performance: Lower Extremity Strength, Left Leg.
Week 14 (N=174, 136)
|
5.3 pounds
Standard Deviation 4.4
|
6.6 pounds
Standard Deviation 4.6
|
|
Physical Performance: Lower Extremity Strength, Left Leg.
Week 26 (N=159, 125)
|
5.6 pounds
Standard Deviation 4.5
|
6.4 pounds
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Weeks 2, 14, 26Population: Enrolled patients with CKD and non-missing data at each time point (indicated by "N").
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.
Outcome measures
| Measure |
CKD With Anemia
n=212 Participants
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.
|
CKD With no Anemia
n=151 Participants
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.
|
|---|---|---|
|
Physical Performance: Lower Extremity Strength, Right Leg
Week 2 (N= 212, 151)
|
5.3 pounds
Standard Deviation 4.0
|
6.3 pounds
Standard Deviation 4.0
|
|
Physical Performance: Lower Extremity Strength, Right Leg
Week 14 (N=174, 136)
|
5.2 pounds
Standard Deviation 4.0
|
6.1 pounds
Standard Deviation 4.1
|
|
Physical Performance: Lower Extremity Strength, Right Leg
Week 26 (N=159, 125)
|
5.6 pounds
Standard Deviation 4.5
|
6.5 pounds
Standard Deviation 4.5
|
Adverse Events
CKD With Anemia
CKD With no Anemia
No CKD, But Anemia
No CKD or Anemia
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER