AnemiaPhase 4NCT00511901
Prevalence and Treatment of Anemia in Rehabilitation Patients
A Phase 4 study testing epoetin alpha and Niferex in people with Anemia, run by University of Medicine and Dentistry of New Jersey at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- epoetin alpha and Niferex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to May 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age or older
- Admission hemoglobin concentration of < 10.5 g/dL.
- Able to read and understand English.
- Consent signed by subjects.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Elms of Cranbury
Cranbury, New Jersey, 08512
Care One East Brunswick
East Brunswick, New Jersey, 08816
About this study
Official title: Prevalence and Treatment of Anemia in Patients Admitted to Subacute Rehabilitation Hospital
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.
Read the 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
- Being tested
- placebo, epoetin alpha, Niferex
- Keywords
- anemia, function, rehabilitation
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
epoetin alphaDrug
Also called Procrit
NiferexDrug
Also called iron polysaccharide
| Study group | Role | What they receive |
|---|---|---|
| Placebo & Niferex | Placebo comparator | Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks Receives: Drug: placebo; Drug: Niferex |
| 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 Receives: Drug: epoetin alpha; Drug: Niferex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study
Measured: 8 weeks following randomization
Secondary outcomes (7)
Motor-FIM Score
FIM Motor score ranges from 13 to 91 (most independent)
Measured: 3, 8, and 12 weeks following randomization
Length of Stay in Subacute Rehabilitation Facility
Days from randomization to discharge
Measured: 12 weeks following randomization
Grip Strength
kilograms measured by hand held dynamometer
Measured: 3, 8, and 12 weeks following randomization
Short Physical Performance Battery (SPPB) Score
Measure physical function scored 0 - 12 (better)
Measured: 3, 8, and 12 weeks following randomization
FACIT Measurement System Fatigue Scale
Fatigue score ranges from 0 to 72. Lower score represents less fatigue
Measured: 3, 8, and 12 weeks following randomization
Activity Counts
Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.
Measured: 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).
Measured: 3,8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startNov 2005
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Carson, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511901
- Sponsor's protocol ID
- 0220045106
- Status last verified
- Nov 2011
- First submitted
- 3 Aug 2007
- Last updated
- 31 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Treatment of Anemia in Patients Admitted to Subacute Rehabilitation Hospital
- ClinicalTrials.gov ID
- NCT00511901
- Acronym / sponsor ID
- 0220045106
- Conditions
- Anemia
- Keywords
- anemia, function, rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study enrollment was suspended in response to an FDA alert regarding the study drug. The study was subsequently terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- Ortho Biotech Clinical Affairs, L.L.C.
- Study start
- Nov 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 6 Aug 2007 (estimated)
- Results
- Posted 11 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo & Niferex | Placebo comparator | Drug: placebo, Drug: NiferexPlacebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks |
| epoetin alpha & Niferex | Active comparator | Drug: epoetin alpha, Drug: Niferex40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 years of age or older
- Admission hemoglobin concentration of < 10.5 g/dL.
- Able to read and understand English.
- Consent signed by subjects.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo | Drug | Placebo & Niferex |
| epoetin alphaAlso: Procrit | Drug | epoetin alpha & Niferex |
| NiferexAlso: iron polysaccharide | Drug | Placebo & Niferex, epoetin alpha & Niferex |
Primary outcome
Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study
Time frame: 8 weeks following randomization
7 secondary outcomes
Motor-FIM Score
Time frame: 3, 8, and 12 weeks following randomization
Length of Stay in Subacute Rehabilitation Facility
Time frame: 12 weeks following randomization
Grip Strength
Time frame: 3, 8, and 12 weeks following randomization
Short Physical Performance Battery (SPPB) Score
Time frame: 3, 8, and 12 weeks following randomization
FACIT Measurement System Fatigue Scale
Time frame: 3, 8, and 12 weeks following randomization
Activity Counts
Time frame: 3, 8, and 12 weeks following randomization
POMS Depression-Dejection Scale
Time frame: 3,8,12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Carson, MD principal investigator
Rutgers, The State University of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epoetin alpha and Niferex in people with Anemia, run by University of Medicine and Dentistry of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study (time frame: 8 weeks following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.