Prevalence and Treatment of Anemia in Rehabilitation Patients

NCT ID: NCT00511901

Last Updated: 2014-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2008-05-31

Brief Summary

Patients who are admitted to subacute rehabilitation facilities following hospitalization are frequently anemic. The purpose of this study is to see if anemic patients treated with epoetin alfa will have higher hemoglobin levels and better functional recovery at 3, 8, and 12 weeks after study entry compared to patients who do not receive epoetin alfa.

Detailed Description

Anemia is associated with loss of function in some studies. However, it is unknown if more rapid correction of anemia in patients who enter a rehabilitation setting after surgery or from hospitalization for acute medical problems leads to shorter rehabilitation stays and improved functional status.

Patients aged 60 and older who have hemoglobin levels of less than 10.5 g/dL will be randomized to receive 8 weekly doses of either erythropoietin alfa or placebo. Functional status will be measured at baseline and then at 3, 8 and 12 weeks.

The following specific aims will be tested in this study:

• Determine the prevalence of anemia in patients admitted to a subacute rehabilitation facility with potential for recovery.
• Determine the baseline functional status of patients admitted to a subacute rehabilitation facility with potential for recovery using the Functional Independence Measure (FIM), an assessment tool used in acute rehabilitation settings.
• Determine if administration of epoetin alfa will result in higher hemoglobin concentrations in patients receiving the drug than in patients given placebo at 3, 8 and 12 weeks after entry into the study.
• Perform a study that establishes the feasibility of a trial to test whether epoetin alfa produces improvements in the FIM, grip strength, the time it takes for patients to reach rehabilitation goals, activity monitor, fatigue, mood, functional recovery and reduces length of rehabilitation stay.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo & Niferex

Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Niferex

Intervention Type: DRUG

epoetin alpha & Niferex

40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks

Group Type: ACTIVE_COMPARATOR

epoetin alpha

Intervention Type: DRUG

Niferex

Intervention Type: DRUG

Interventions

placebo

Intervention Type: DRUG

epoetin alpha

Intervention Type: DRUG

Niferex

Intervention Type: DRUG

Other Intervention Names

Procrit; iron polysaccharide

Eligibility Criteria

Inclusion Criteria

• 60 years of age or older
• Admission hemoglobin concentration of < 10.5 g/dL.
• Able to read and understand English.
• Consent signed by subjects.

Exclusion Criteria

• Unable to randomize within 7 days of admission to rehabilitation center.
• Folstein min-mental status score of < 21.
• Neuromuscular disease and/or disability; in clinical judgment of the investigators that do not have rehabilitation potential.
• Diagnosis or evidence of carcinoma (excluding skin cancer other than melanoma) within the past five years
• Admission for stroke with residual deficit
• Wheelchair bound prior to acute event.
• Dialysis dependent chronic renal failure
• Home more than 1 hour drive from hospital.
• Admitted to long term nursing or hospice care.
• Active blood loss.
• Known history of severe iron deficiency.
• Hematological disease that results in anemia that may not respond to erythropoietin (including, but not limited to, myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy).
• Uncontrolled hypertension (systolic BP >200 mmHg or diastolic BP >110 mmHg) after adequate antihypertensive therapy.
• New onset seizures (within three months) or seizures not controlled by medication.
• Objective diagnosis of pulmonary embolism or deep vein thrombosis within the past 10 years.
• Patients with a condition (e.g. psychiatric illness) or in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's compliance with study procedures.
• Acute burns.
• Treatment with any recombinant human erythropoietin within 30 days prior to enrollment.
• Known hypersensitivity to human albumin or mammalian cell-derived products or recombinant human erythropoietin (rHuEPO).
• Received an experimental drug or used an experimental medical device within 30 days prior to the planned start of treatment.
• Pregnancy or lactation.
• Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech Clinical Affairs, L.L.C.

INDUSTRY

Sponsor Role: collaborator

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey L Carson, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Elms of Cranbury

Cranbury, New Jersey, United States

Care One East Brunswick

East Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

0220045106

Identifier Type: -

Identifier Source: org_study_id