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

Amgen

Status: Completed

Conditions: Chronic Kidney Disease; Anemia

Treatments: Other: Observations

Study type: Observational

Funder types: Industry

Identifiers

NCT00727571

20050239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 815 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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
• 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• Previously withdrawn from this study

Trial design

815 participants in 4 patient groups

No CKD or Anemia

Description:

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.

Treatment:

Other: Observations

No CKD, but Anemia

Description:

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.

Treatment:

Other: Observations

CKD with Anemia

Description:

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.

Treatment:

Other: Observations

CKD with no Anemia

Description:

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.

Treatment:

Other: Observations