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Prevalence and Treatment of Anemia in Rehabilitation Patients

Primary Purpose

Anemia

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

placebo

epoetin alpha

Niferex

About this trial

This is an interventional treatment trial for Anemia focused on measuring anemia, function, rehabilitation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Elms of Cranbury
Care One East Brunswick

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo & Niferex

epoetin alpha & Niferex

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study

Secondary Outcome Measures

Motor-FIM Score

FIM Motor score ranges from 13 to 91 (most independent)

Length of Stay in Subacute Rehabilitation Facility

Days from randomization to discharge

Grip Strength

kilograms measured by hand held dynamometer

Short Physical Performance Battery (SPPB) Score

Measure physical function scored 0 - 12 (better)

FACIT Measurement System Fatigue Scale

Fatigue score ranges from 0 to 72. Lower score represents less fatigue

Activity Counts

Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.

POMS Depression-Dejection Scale

Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed).

Full Information

NCT ID

NCT00511901

First Posted

August 3, 2007

Last Updated

December 27, 2013

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Ortho Biotech Clinical Affairs, L.L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00511901

Brief Title

Prevalence and Treatment of Anemia in Rehabilitation Patients

Official Title

Prevalence and Treatment of Anemia in Patients Admitted to Subacute Rehabilitation Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Terminated

Why Stopped

Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated

Study Start Date

November 2005 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Ortho Biotech Clinical Affairs, L.L.C.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

Keywords

anemia, function, rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo & Niferex

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

epoetin alpha & Niferex

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Type

Drug

Intervention Name(s)

epoetin alpha

Other Intervention Name(s)

Procrit

Intervention Type

Drug

Intervention Name(s)

Niferex

Other Intervention Name(s)

iron polysaccharide

Primary Outcome Measure Information:

Title

Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study

Time Frame

8 weeks following randomization

Secondary Outcome Measure Information:

Title

Motor-FIM Score

Description

FIM Motor score ranges from 13 to 91 (most independent)

Time Frame

3, 8, and 12 weeks following randomization

Title

Length of Stay in Subacute Rehabilitation Facility

Description

Days from randomization to discharge

Time Frame

12 weeks following randomization

Title

Grip Strength

Description

kilograms measured by hand held dynamometer

Time Frame

3, 8, and 12 weeks following randomization

Title

Short Physical Performance Battery (SPPB) Score

Description

Measure physical function scored 0 - 12 (better)

Time Frame

3, 8, and 12 weeks following randomization

Title

FACIT Measurement System Fatigue Scale

Description

Fatigue score ranges from 0 to 72. Lower score represents less fatigue

Time Frame

3, 8, and 12 weeks following randomization

Title

Activity Counts

Description

Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.

Time Frame

3, 8, and 12 weeks following randomization

Title

POMS Depression-Dejection Scale

Description

Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed).

Time Frame

3,8,12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey L Carson, MD

Organizational Affiliation

Rutgers, The State University of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Elms of Cranbury

City

Cranbury

State/Province

New Jersey

ZIP/Postal Code

08512

Country

United States

Facility Name

Care One East Brunswick

City

East Brunswick

State/Province

New Jersey

ZIP/Postal Code

08816

Country

United States

12. IPD Sharing Statement

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Prevalence and Treatment of Anemia in Rehabilitation Patients

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