N/A
N=794
LEARN-6™: A Prospective, Observational Nursing Home Study
Anemia · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00727571 ↗Enrolled (actual)
794
Serious AEs
—
Results posted
Nov 2013
Primary outcome: Primary: Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit — 210.0; 253.1; 210.0; 246.5 feet
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Observations (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit |
210.0; 253.1; 210.0; 246.5; 185.0; 198.5 | — |
| SECONDARY Number of Participants With Anemia |
397 | — |
| SECONDARY Percentage of Participants With Anemia Related Conditions at Baseline |
0.0; 0.0; 2.6; 5.3; 11.4; 10.1 | — |
| SECONDARY Estimated Glomerular Filtration Rate (GFR) for Participants With CKD |
42.1; 44.9; 42.6; 48.0; 45.2; 48.0 | — |
| SECONDARY Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit |
51.2; 61.9; 51.0; 70.1; 49.9; 66.5 | — |
| SECONDARY Physical Performance: Duration Walked or Wheeled at Each Visit |
6.4; 6.2; 6.5; 6.4; 6.6; 6.0 | — |
| SECONDARY Physical Performance: Time to Rise From Sitting to Standing |
3.0; 3.0; 2.5; 3.0; 3.0; 3.0 | — |
| SECONDARY Physical Performance: Grip Strength |
29.6; 31.8; 29.8; 32.5; 29.0; 29.8 | — |
| SECONDARY Physical Performance: Lower Extremity Strength, Left Leg. |
5.3; 6.1; 5.3; 6.6; 5.6; 6.4 | — |
| SECONDARY Physical Performance: Lower Extremity Strength, Right Leg |
5.3; 6.3; 5.2; 6.1; 5.6; 6.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00727571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.