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AnemiaNCT00727571

LEARN-6™: A Prospective, Observational Nursing Home Study

An observational study of Anemia and Chronic Kidney Disease, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Anemia, Chronic Kidney Disease
What is being tested?
Observations
How many people
815 participants
Where
No sites listed yet
Study dates
Sep 2006to Jul 2008
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Older, long-term stay Nursing Home (NH) residents with CKD, with and without anemia

Who may be able to join

  • 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

Who cannot join

  • 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  • Previously withdrawn from this study

About this study

Official title: Prospective Observational Study to Evaluate Physical Performance and Quality of Life in Older Long Stay Nursing Home Residents With Chronic Kidney Disease With and Without Anemia

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.

Read the 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.

Being tested
Observations
Keywords
Anemia, Chronic Kidney Disease, Quality of Life, CKD, Chronic Renal Insufficiency
Medical subject headings
Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationsOther

    This is a non-interventional, observational study; no investigational product is being used

Study groups in NCT00727571
Study groupRoleWhat they receive
No CKD or AnemiaChronic 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.
Receives: Other: Observations
No CKD, but AnemiaCKD 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.
Receives: Other: Observations
CKD with AnemiaCKD 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.
Receives: Other: Observations
CKD with no AnemiaCKD 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.
Receives: Other: Observations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Weeks 2, 14 and 26

Secondary outcomes (9)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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).

    Measured: Weeks 1, 14 and 26

  4. 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.

    Measured: Weeks 2, 14 and 26

  5. 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.

    Measured: Weeks 2, 14, 26

  6. 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.

    Measured: Weeks 2, 14, 26

  7. 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.

    Measured: Weeks 2, 14, 26

  8. 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.

    Measured: Weeks 2, 14, 26

  9. 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.

    Measured: Weeks 2, 14, 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2008 (estimated)
  2. Study startSep 2006
  3. Primary completionJun 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
815 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00727571
Sponsor's protocol ID
20050239
Status last verified
Jul 2014
First submitted
31 Jul 2008
Last updated
25 Jul 2014

Publications

  • 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.

    PubMed 22568452

  • 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.

    PubMed 20129213

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia and Chronic Kidney Disease, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit (time frame: Weeks 2, 14 and 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00727571, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2014.

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