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

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00727571
First received: July 31, 2008
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

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 subjects with CKD, with versus without anemia. Enrolled subjects 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, subjects will be categorized into 1 of 4 groups.


Condition Intervention
Anemia
Chronic Kidney Disease
 Other: Observations

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The distance a subject walks, with or without an assistive device, and stand-by assistance of one person, or propels themselves in their wheelchair, with or without the use of their feet, over level ground [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with anemia, defined by WHO criteria [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Among those with anemia, the proportion with anemia associated with CKD, nutritional deficiencies (iron, B12 and folate), GI bleed, and chronic disease based upon the study-specific anemia lab workup [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
  • For all subjects, calculated GFR using the MDRD 4-variable and Cockroft-Gault equations [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]
  • Physical performance measures for all subjects with CKD, defined as eGFR <60 mL/min/1.73m2 [ Time Frame: Weeks 2, 14 and 26 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

N/A (None Retained)


Enrollment: 815
Study Start Date: September 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group IV
No CKD, no Anemia
 Other: Observations
This is a non-interventional, observational study; no investigational product is being used
Group III
Anemia, no CKD
 Other: Observations
This is a non-interventional, observational study; no investigational product is being used
Group I
CKD, Anemia
 Other: Observations
This is a non-interventional, observational study; no investigational product is being used
Group II
CKD, no Anemia
 Other: Observations
This is a non-interventional, observational study; no investigational product is being used

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Older, long-term stay nursing home residents with CKD, with and without anemia

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
  • Subject currently is enrolled in or has not yet completed at least 30 days since ending investigational device or drug study(s), or subject is receiving investigational agent(s)
  • Subject currently is enrolled in an interventional trial
  • Subject previously withdrawn from this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727571

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00727571     History of Changes
Other Study ID Numbers: 20050239
Study First Received: July 31, 2008
Last Updated: October 15, 2009
Health Authority: United States: Institutional Review Board
United States: Quorom Institutional Review Board

Keywords provided by Amgen:
Anemia
Chronic Kidney Disease
Quality of Life
CKD
Chronic Renal Insufficiency

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013