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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00727571
First received: July 31, 2008
Last updated: July 18, 2014
Last verified: July 2014
Results First Received: October 29, 2009  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Anemia
Chronic Kidney Disease
Intervention: Other: Observations

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
815 patients were enrolled; 21 of these could not be classified into the defined groups because of missing lab values at enrollment. Their anemic/CKD status is therefore not available.

Reporting Groups
  Description
No CKD or Anemia Chronic kidney disease (CKD) is based on an 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.
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.
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.
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.

Participant Flow:   Overall Study
    No CKD or Anemia     CKD With Anemia     CKD With no Anemia     No CKD, But Anemia  
STARTED     232     228     165     169  
COMPLETED     231     173     135     163  
NOT COMPLETED     1     55     30     6  
Ineligibility determined                 1                 1                 1                 0  
Death                 0                 19                 5                 1  
Physician Decision                 0                 5                 0                 0  
Withdrawal by Subject                 0                 10                 11                 0  
Subject Non Compliance                 0                 6                 0                 4  
Dismissed from nursing home                 0                 9                 5                 0  
Hospitalization                 0                 1                 0                 1  
AE not leading to hospitalization                 0                 0                 2                 0  
Other                 0                 4                 6                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
No CKD or 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.
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.
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.
Total Total of all reporting groups

Baseline Measures
    No CKD, But Anemia     No CKD or Anemia     CKD With Anemia     CKD With no Anemia     Total  
Number of Participants  
[units: participants]
  169     232     228     165     794  
Age  
[units: Years]
Mean ± Standard Deviation
  82.6  ± 8.3     81.6  ± 8.2     84.6  ± 8.1     83.8  ± 8.4     83.1  ± 8.3  
Gender  
[units: Participants]
         
Female     88     172     159     139     558  
Male     81     60     69     26     236  



  Outcome Measures
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1.  Primary:   Total Distance Walked or Wheeled in a Maximum of 10 Minutes at Each Visit   [ Time Frame: Weeks 2, 14 and 26 ]

2.  Secondary:   Number of Participants With Anemia   [ Time Frame: Baseline ]

3.  Secondary:   Percentage of Participants With Anemia Related Conditions at Baseline   [ Time Frame: Baseline ]

4.  Secondary:   Estimated Glomerular Filtration Rate (GFR) for Participants With CKD   [ Time Frame: Weeks 1, 14 and 26 ]

5.  Secondary:   Physical Performance: Speed Walked or Wheeled in a Maximum of 10 Minutes at Each Visit   [ Time Frame: Weeks 2, 14 and 26 ]

6.  Secondary:   Physical Performance: Duration Walked or Wheeled at Each Visit   [ Time Frame: Weeks 2, 14, 26 ]

7.  Secondary:   Physical Performance: Time to Rise From Sitting to Standing   [ Time Frame: Weeks 2, 14, 26 ]

8.  Secondary:   Physical Performance: Grip Strength   [ Time Frame: Weeks 2, 14, 26 ]

9.  Secondary:   Physical Performance: Lower Extremity Strength, Left Leg.   [ Time Frame: Weeks 2, 14, 26 ]

10.  Secondary:   Physical Performance: Lower Extremity Strength, Right Leg   [ Time Frame: Weeks 2, 14, 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
21 subjects could not be classified into the defined groups because of missing lab values at enrollment


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00727571     History of Changes
Other Study ID Numbers: 20050239
Study First Received: July 31, 2008
Results First Received: October 29, 2009
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board
United States: Quorom Institutional Review Board