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Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated
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| Name | Class |
|---|---|
| Ortho Biotech Clinical Affairs, L.L.C. | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo & Niferex | Placebo Comparator | Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks |
|
| epoetin alpha & Niferex | Active Comparator | 40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug |
| ||
| epoetin alpha |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study | 8 weeks following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Motor-FIM Score | FIM Motor score ranges from 13 to 91 (most independent) | 3, 8, and 12 weeks following randomization |
| Length of Stay in Subacute Rehabilitation Facility | Days from randomization to discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Carson, MD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elms of Cranbury | Cranbury | New Jersey | 08512 | United States | ||
| Care One East Brunswick |
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Subjects recruited at two subacute rehabilitation facilities in Central New Jersey between October 2005 and March 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo & Niferex | Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention to treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo & Niferex | Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study | Intention to treat; of the subjects not lost to follow-up, 3 subjects in the placebo arm & 2 subjects in the epoetin alpha arm were not available for 8 week hemoglobin draw | Posted | Mean | Standard Deviation | g/dL | 8 weeks following randomization |
|
12 weeks
active followup at 3, 8, & 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo & Niferex | Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip Fracture | Musculoskeletal and connective tissue disorders | Hip Fracture | Systematic Assessment | Hip Fracture |
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Limited number of eligible subjects, burdensome protocol requirements impeded recruitment, controversy concerning safety of epoetin alpha which led to early termination of study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey L Carson, MD | University of Medicine and Dentistry of New Jersey | 732-235-7122 | carson@umdnj.edu |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| C078972 | Niferex |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
|
| Niferex | Drug |
|
|
| 12 weeks following randomization |
| Grip Strength | kilograms measured by hand held dynamometer | 3, 8, and 12 weeks following randomization |
| Short Physical Performance Battery (SPPB) Score | Measure physical function scored 0 - 12 (better) | 3, 8, and 12 weeks following randomization |
| FACIT Measurement System Fatigue Scale | Fatigue score ranges from 0 to 72. Lower score represents less fatigue | 3, 8, and 12 weeks following randomization |
| Activity Counts | Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity. | 3, 8, and 12 weeks following randomization |
| 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). | 3,8,12 weeks |
| East Brunswick |
| New Jersey |
| 08816 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Hemoglobin Level | Level Prior to Randomization | Mean | Standard Deviation | g/dL |
|
| Days From Admit to Randomization | # of days from admission to the subacute rehabilitation facility to randomization into the study | Mean | Standard Deviation | Days |
|
| FIM Motor Scale | The Functional Independence Measure scale is a 7 point rating scale used as part of the Uniform Data System for Medical Rehabilitation. The FIM motor score ranges from 13 to 91 (most independent). | Mean | Standard Deviation | Scores on a Scale |
|
| FACIT Fatigue Scale | FACIT-Fatigue Scale (version 4) 13 item questionnaire to assess level of fatigue. The FACIT-Fatigue scores range from 0 to 52(most fatigue). | Mean | Standard Deviation | Scores on a Scale |
|
| POMS Depression-Dejection Scale | Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The POMS scores range from 0 to 60(most depressed). | Median | Inter-Quartile Range | Scores on a Scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Motor-FIM Score | FIM Motor score ranges from 13 to 91 (most independent) | exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up | Posted | Mean | Standard Deviation | Scores on a Scale | 3, 8, and 12 weeks following randomization |
|
|
|
|
| Secondary | Length of Stay in Subacute Rehabilitation Facility | Days from randomization to discharge | exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up | Posted | Mean | Standard Deviation | Days | 12 weeks following randomization |
|
|
|
|
| Secondary | Grip Strength | kilograms measured by hand held dynamometer | exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up | Posted | Mean | Standard Deviation | kg | 3, 8, and 12 weeks following randomization |
|
|
|
|
| Secondary | Short Physical Performance Battery (SPPB) Score | Measure physical function scored 0 - 12 (better) | exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up | Posted | Mean | Standard Deviation | Scores on a scale | 3, 8, and 12 weeks following randomization |
|
|
|
|
| Secondary | FACIT Measurement System Fatigue Scale | Fatigue score ranges from 0 to 72. Lower score represents less fatigue | exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up | Posted | Mean | Standard Deviation | Scores on a Scale | 3, 8, and 12 weeks following randomization |
|
|
|
|
| Secondary | Activity Counts | Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity. | exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up | Posted | Mean | Standard Deviation | Counts | 3, 8, and 12 weeks following randomization |
|
|
|
|
| Secondary | 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). | exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up | Posted | Median | Inter-Quartile Range | Scores on a Scale | 3,8,12 weeks |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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 | 1 | 11 | 0 | 11 |
|
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| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| FIM at 12 weeks (n=10; n=8) |
|
| 0.17 |
| Mean Difference (Net) |
| 3.3 |
| 95 |
| No |
| Superiority or Other |
| FIM at 12 weeks | Wilcoxon (Mann-Whitney) | 0.59 | Mean Difference (Net) | -0.1 | 95 | No | Superiority or Other |
| Grip Strength at 12 weeks (n=10; n=8) |
|
| 1.00 |
| Mean Difference (Net) |
| 0.2 |
| 95 |
| No |
| Superiority or Other |
| Grip strength at 12 weeks | Wilcoxon (Mann-Whitney) | 0.53 | Mean Difference (Net) | 1.6 | 95 | No | Superiority or Other |
| SPPB at 12 weeks (n=10; n=8) |
|
| 1.00 |
| Mean Difference (Net) |
| 0.4 |
| 95 |
| No |
| Superiority or Other |
| SPPB at 12 weeks | Wilcoxon (Mann-Whitney) | 0.66 | Mean Difference (Net) | -0.9 | 95 | No | Superiority or Other |
| FACIT at 12 weeks (n=10; n=8) |
|
| 0.83 |
| Mean Difference (Net) |
| 2.5 |
| 95 |
| No |
| Superiority or Other |
| FACIT at 12 weeks | Wilcoxon (Mann-Whitney) | 0.46 | Mean Difference (Net) | -4.1 | 95 | No | Superiority or Other |
| Activity Counts at 12 weeks (n=10; n=8) |
|
| 0.69 |
| Mean Difference (Net) |
| 11.39 |
| 95 |
| No |
| Superiority or Other |
| Activity Counts at 12 weeks | Wilcoxon (Mann-Whitney) | 0.36 | Mean Difference (Net) | 16.15 | 95 | No | Superiority or Other |
| POMS at 12 weeks (n=10; n=7) |
|
| 0.46 |
| Median Difference (Net) |
| -1 |
| 95 |
| No |
| Superiority or Other |
| POMS at 12 weeks | Wilcoxon (Mann-Whitney) | 0.68 | Median Difference (Net) | -1 | 95 | No | Superiority or Other |