AnemiaPhase 4NCT00338468
A Study to Assess Disability in Anemic Elderly Patients With Kidney Disease Receiving PROCRIT (Epoetin Alfa)
A Phase 4 study testing epoetin alfa in people with Anemia and Kidney Diseases, run by Ortho Biotech Products, L.P..
Trial summary
The purpose of this study is to assess disability in anemic patients over the age of 65 who have kidney disease and are receiving weekly PROCRIT® (Epoetin Alfa, a glycoprotein that stimulates red blood cell production). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anemia, Kidney Diseases
- What is being tested?
- epoetin alfa
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Sep 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients having chronic anemia and chronic renal failure
- have lessened physical function
- be community dwelling (defined as not admitted to an assisted nursing facility, nursing home or hospital at the time of enrollment. An assisted nursing facility is considered any living situation where daily care is being provided by recognized health care professionals from that facility.)
Who cannot join
- History of bacterial infection requiring hospitalization and intravenous antibiotics or transfusion within 1 month prior to enrollment
- anemia due to iron, folate, or vitamin B12 deficiency
- gastrointestinal bleeding
- anticipated to begin dialysis within 4 months following enrollment into the study
- History of thrombotic disease within the past 3 months, or on anticoagulation therapy at enrollment.
About this study
Official title: An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients With Chronic Kidney Disease Receiving PROCRIT (Epoetin Alfa)
The purpose of this study is to assess disability in anemic patients over the age of 65 who have kidney disease and are receiving weekly PROCRIT® (Epoetin Alfa, a glycoprotein that stimulates red blood cell production).
Read the detailed description
This is an open-label study in which PROCRIT® (Epoetin Alfa) will be given on a weekly basis starting at a dose lower than is currently approved by the U.S. FDA because treatment is beginning at a higher hemoglobin than usual. There is recent evidence to suggest that problems with disability occur in persons over 65 at higher hemoglobins than previously recognized. Currently, PROCRIT® (Epoetin Alfa) is prescribed for patients with chronic kidney disease three times a week at a dose of approximately 5,000 and 10,000 units per injection depending on the patient's weight. This study is starting with a lower dose because treatment is beginning earlier than it normally would. Currently, doctors usually do not begin PROCRIT® (Epoetin Alfa) in patients with chronic kidney disease until their hemoglobin is <10 g/dL.
In this study PROCRIT® (Epoetin Alfa) will be given on a weekly basis starting at 5,000 units per injection if hemoglobin is <12 g/dL. Each week hemoglobin will be checked and if after four weeks of treatment it is < 13 g/dL, the PROCRIT® (Epoetin Alfa) dose will be increased to 10,000 Units. After another four weeks of treatment if the hemoglobin is <13 g/dL, PROCRIT® (Epoetin Alfa) will be increased to 20,000 units. After another four weeks of treatment if the hemoglobin is <13 g/dL, PROCRIT® (Epoetin Alfa) will be increased once more to a final dose of 40,000 units. In this study, patients will be treated with doses higher than currently approved for patients with chronic kidney disease. The primary measures of efficacy will be assessed using two disability tests to measure physical function compared from baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up. The first test is called the "Short Physical Performance Battery" (SPP) which will test how well someone sits, stands and walks. The second test is called the "Six Minute Walk Test" (6MWT) which measures how far someone can walk during a six-minute period. Normal walking aids are allowed during this test. The study will also evaluate hemoglobin levels, number of transfusions, safety, incidence of anti-erythropoietin antibodies, Quality of Life and cognitive function (a measure of how clearly one is thinking). The study hypothesis is that physical function will improve when the hemoglobin level is increased. Patients will receive PROCRIT® (Epoetin Alfa) on a weekly basis starting at 5,000 units per injection (up to a maximum of 40,000 units).
- Conditions
- Anemia, Kidney Diseases
- Being tested
- epoetin alfa
- Keywords
- Anemia, Elderly, Hemoglobin level, Chronic Kidney Disease
- Medical subject headings
- Anemia, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical function score as measured by the Six Minute Walk Test (6MWT) and Short Physical Performance (SPP) Summary Score compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.
Secondary outcomes (1)
Proportion of patients who achieve the target hemoglobin levels of > 13.0 g/dL and < =14.0 g/dL (independent of transfusion within 1 month of assessment) compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startNov 2003
- Study completionSep 2005
Why it stopped: The study was stopped early due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Biotech Products, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho Biotech Products, L.P. Clinical Trial, Study director, Ortho Biotech Products, L.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338468
- Sponsor's protocol ID
- CR004606
- Status last verified
- Mar 2010
- First submitted
- 16 Jun 2006
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients With Chronic Kidney Disease Receiving PROCRIT (Epoetin Alfa)
- ClinicalTrials.gov ID
- NCT00338468
- Acronym / sponsor ID
- CR004606
- Conditions
- Anemia, Kidney Diseases
- Keywords
- Anemia, Elderly, Hemoglobin level, Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early due to slow enrollment.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Sep 2005 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess disability in anemic patients over the age of 65 who have kidney disease and are receiving weekly PROCRIT® (Epoetin Alfa, a glycoprotein that stimulates red blood cell production).
Detailed description
This is an open-label study in which PROCRIT® (Epoetin Alfa) will be given on a weekly basis starting at a dose lower than is currently approved by the U.S. FDA because treatment is beginning at a higher hemoglobin than usual. There is recent evidence to suggest that problems with disability occur in persons over 65 at higher hemoglobins than previously recognized. Currently, PROCRIT® (Epoetin Alfa) is prescribed for patients with chronic kidney disease three times a week at a dose of approximately 5,000 and 10,000 units per injection depending on the patient's weight. This study is starting with a lower dose because treatment is beginning earlier than it normally would. Currently, doctors usually do not begin PROCRIT® (Epoetin Alfa) in patients with chronic kidney disease until their hemoglobin is <10 g/dL.
In this study PROCRIT® (Epoetin Alfa) will be given on a weekly basis starting at 5,000 units per injection if hemoglobin is <12 g/dL. Each week hemoglobin will be checked and if after four weeks of treatment it is < 13 g/dL, the PROCRIT® (Epoetin Alfa) dose will be increased to 10,000 Units. After another four weeks of treatment if the hemoglobin is <13 g/dL, PROCRIT® (Epoetin Alfa) will be increased to 20,000 units. After another four weeks of treatment if the hemoglobin is <13 g/dL, PROCRIT® (Epoetin Alfa) will be increased once more to a final dose of 40,000 units. In this study, patients will be treated with doses higher than currently approved for patients with chronic kidney disease. The primary measures of efficacy will be assessed using two disability tests to measure physical function compared from baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up. The first test is called the "Short Physical Performance Battery" (SPP) which will test how well someone sits, stands and walks. The second test is called the "Six Minute Walk Test" (6MWT) which measures how far someone can walk during a six-minute period. Normal walking aids are allowed during this test. The study will also evaluate hemoglobin levels, number of transfusions, safety, incidence of anti-erythropoietin antibodies, Quality of Life and cognitive function (a measure of how clearly one is thinking). The study hypothesis is that physical function will improve when the hemoglobin level is increased. Patients will receive PROCRIT® (Epoetin Alfa) on a weekly basis starting at 5,000 units per injection (up to a maximum of 40,000 units).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients having chronic anemia and chronic renal failure
- have lessened physical function
- be community dwelling (defined as not admitted to an assisted nursing facility, nursing home or hospital at the time of enrollment. An assisted nursing facility is considered any living situation where daily care is being provided by recognized health care professionals from that facility.)
Key exclusion criteria (5 listed)
- History of bacterial infection requiring hospitalization and intravenous antibiotics or transfusion within 1 month prior to enrollment
- anemia due to iron, folate, or vitamin B12 deficiency
- gastrointestinal bleeding
- anticipated to begin dialysis within 4 months following enrollment into the study
- History of thrombotic disease within the past 3 months, or on anticoagulation therapy at enrollment.
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 |
|---|---|---|
| epoetin alfa | Drug | – |
Primary outcome
Change in physical function score as measured by the Six Minute Walk Test (6MWT) and Short Physical Performance (SPP) Summary Score compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.
1 secondary outcome
Proportion of patients who achieve the target hemoglobin levels of > 13.0 g/dL and < =14.0 g/dL (independent of transfusion within 1 month of assessment) compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.
Results and safety
The study was stopped early (reason given: The study was stopped early due to slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- An Open-Label Pilot Study to Assess Disability in Anemic Elderly Patients with Chronic Kidney Disease Receiving PROCRIT (Epoetin alfa)Link provided by the sponsor.
Related trials for Anemia
RecruitingPhase 1/2
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Dibotatug (DR-01) in Adults With Bone Marrow Failure Syndromes
Bone Marrow Failure Syndromes, Aplastic Anemias
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
RecruitingPhase 1
F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
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.
Ortho Biotech Products, L.P. Clinical Trial study director
Ortho Biotech Products, L.P.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epoetin alfa in people with Anemia and Kidney Diseases, run by Ortho Biotech Products, L.P..
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 3 inclusion and 5 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was stopped early (reason given: The study was stopped early due to slow enrollment.). Results are not available in the source record.
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?
Change in physical function score as measured by the Six Minute Walk Test (6MWT) and Short Physical Performance (SPP) Summary Score compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.. 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 19 May 2011.