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

NCT00727571 | Completed Results

• 1 other identifier: 20050239
• Study Type: observational
• Target: 815
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia; Chronic Kidney Disease

Keywords

Anemia; Chronic Kidney Disease; Quality of Life; CKD; Chronic Renal Insufficiency

Outcome Measures

Primary Outcomes (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).

  Weeks 2, 14 and 26

Secondary Outcomes (9)

• Number of Participants With Anemia

  Baseline

• Percentage of Participants With Anemia Related Conditions at Baseline

  Baseline

• Estimated Glomerular Filtration Rate (GFR) for Participants With CKD

  Weeks 1, 14 and 26

• Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit

  Weeks 2, 14 and 26

• Physical Performance: Duration Walked or Wheeled at Each Visit

  Weeks 2, 14, 26

Study Arms (4)

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.

Other: Observations

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.

Other: Observations

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.

Other: Observations

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.

Other: Observations

Interventions

Observations OTHER

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

CKD with Anemia; CKD with no Anemia; No CKD or Anemia; No CKD, but Anemia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• 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.

  PMID: 22568452 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.

  PMID: 20129213 BACKGROUND

Related Links

• AmgenTrials clinical trials website

Biospecimen

Retention: NONE RETAINED

N/A (None Retained)

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Limitations and Caveats

21 subjects could not be classified into the defined groups because of missing lab values at enrollment

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 4, 2008
• Study Start: September 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 25, 2014
• Results First Posted: November 27, 2013

Record last verified: 2014-07