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

Tracking Information

First Received Date ^ICMJE

July 31, 2008

Last Updated Date

October 15, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00727571 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: None Retained

Description:

N/A (None Retained)

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Anemia
Chronic Kidney Disease

Intervention ^ICMJE

Other: Observations

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

Study Group/Cohort (s)

Group IV
No CKD, no Anemia

Intervention: Other: Observations
Group III
Anemia, no CKD

Intervention: Other: Observations
Group I
CKD, Anemia

Intervention: Other: Observations
Group II
CKD, no Anemia

Intervention: Other: Observations

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

815

Completion Date

July 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00727571

Other Study ID Numbers ^ICMJE

20050239

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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