AnemiaPhase 4NCT00495365
A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.
A Phase 4 study testing Epoetin alfa in people with Anemia and Chronic Renal Insufficiency, run by Ortho Biotech Products, L.P..
Trial summary
The purpose of this study was to evaluate hemoglobin stability in subjects who had received darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus 1 g/dL (range 11-13- g/dL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Chronic Renal Insufficiency
- What is being tested?
- Epoetin alfa
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Sep 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with chronic kidney disease defined as serum creatinine of 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 mg/dL for men
- glomerular filtration rate (GFR) within 15-60 mL/min
- Subjects on darbepoetin alfa for 3 months or more and with a stable entry hemoglobin level of 12 (plus or minus 1 g/dL
- range 11-13 g/dL)
- Subjects receiving darbepoetin alfa on an every two, three, or four week dosing schedule
- female subjects with a reproductive potential must have a negative ruine pregnancy test within 7days of the first dose of study drug.
Who cannot join
- No uncontrolled high blood pressure as assessed by the primary physician
- No known hypersensitivity to mammalian cell-derived products
- No known hypersensitivity to human albumin
- Not receiving dialysis or scheduled to receive dialysis during the course of the study
- No severe congestive heart failure (New York Heart Association Class IV)
- No known severe stable or unstable coronary artery disease.
About this study
Official title: Evaluation of Dose Conversion From Variable Dosing Intervals of Darbepoetin Alfa to Variable Dosing Intervals of Epoetin Alfa in Patients With the Anemia of Chronic Kidney Disease
The purpose of this study was to evaluate hemoglobin stability in subjects who had received darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus 1 g/dL (range 11-13- g/dL).
Read the detailed description
This was a prospective, multicenter study in subjects with chronic kidney disease. The study was designed to address hemoglobin stability after drug conversion to epoetin alfa in subjects previously receiving darbepoetin alfa therapy.
The study was to enroll approximately 180 subjects with chronic kidney disease. Eligible subjects were those with chronic kidney disease who were receiving darbepoetin alfa every two, three, or four weeks for a period of 3 months or more and who had a stable hemoglobin (Hb) level at study entry of 12 g/dL (plus or minus 1 g/dL (11-13 g/dL). Subjects receiving darbepoetin alfa every 2, 3 or 4 weeks were switched over to epoetin alfa which they received at the same dosing frequency ( every 2, 3 or 4 weeks) upon study entry and throughout the 24 week study period. Clinical safety was assessed for the occurrence and severity of adverse events. Blood tests (Complete Blood Count, platelets, reticulocyte count, iron, were assessed at pre-determined intervals throughout the study. Vital signs (e.g. Blood pressure) were checked at each visit. Subjects received epoetin alfa at the same dosing frequency that they had previously received darbepoetin alfa. Subjects received 20,000 Units (U) epoetin alfa subcutaneously (SC) every two weeks; 30,000 U epoetin alfa SC every 3 weeks; or 40,000 U epoetin alfa SC every 4 weeks.
- Conditions
- Anemia, Chronic Renal Insufficiency
- Being tested
- Epoetin alfa
- Keywords
- Anemia, low blood count, chronic kidney disease, chronic kidney failure, darbepoetin alfa, epoetin alfa, recombinant human erythropoietin
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Kidney Failure, 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.
The primary objective was to evaluate the proportion of subjects who maintained hemoglobin levels within 10% of entry levels and/or a range of 11-13 g/dL for the 24-week duration of the study.
Secondary outcomes (1)
The secondary objective was to evaluate safety in subjects with chronic kidney disease throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startJun 2003
- Study completionSep 2003
Why it stopped: This study was stopped 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT00495365
- Sponsor's protocol ID
- CR005104
- Status last verified
- Apr 2010
- First submitted
- 29 Jun 2007
- 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
- Evaluation of Dose Conversion From Variable Dosing Intervals of Darbepoetin Alfa to Variable Dosing Intervals of Epoetin Alfa in Patients With the Anemia of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00495365
- Acronym / sponsor ID
- CR005104
- Conditions
- Anemia, Chronic Renal Insufficiency
- Keywords
- Anemia, low blood count, chronic kidney disease, chronic kidney failure, darbepoetin alfa, epoetin alfa, recombinant human erythropoietin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped due to slow enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Sep 2003 (actual)
- First posted
- 3 Jul 2007 (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 was to evaluate hemoglobin stability in subjects who had received darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus 1 g/dL (range 11-13- g/dL).
Detailed description
This was a prospective, multicenter study in subjects with chronic kidney disease. The study was designed to address hemoglobin stability after drug conversion to epoetin alfa in subjects previously receiving darbepoetin alfa therapy.
The study was to enroll approximately 180 subjects with chronic kidney disease. Eligible subjects were those with chronic kidney disease who were receiving darbepoetin alfa every two, three, or four weeks for a period of 3 months or more and who had a stable hemoglobin (Hb) level at study entry of 12 g/dL (plus or minus 1 g/dL (11-13 g/dL). Subjects receiving darbepoetin alfa every 2, 3 or 4 weeks were switched over to epoetin alfa which they received at the same dosing frequency ( every 2, 3 or 4 weeks) upon study entry and throughout the 24 week study period. Clinical safety was assessed for the occurrence and severity of adverse events. Blood tests (Complete Blood Count, platelets, reticulocyte count, iron, were assessed at pre-determined intervals throughout the study. Vital signs (e.g. Blood pressure) were checked at each visit. Subjects received epoetin alfa at the same dosing frequency that they had previously received darbepoetin alfa. Subjects received 20,000 Units (U) epoetin alfa subcutaneously (SC) every two weeks; 30,000 U epoetin alfa SC every 3 weeks; or 40,000 U epoetin alfa SC every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with chronic kidney disease defined as serum creatinine of 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 mg/dL for men
- glomerular filtration rate (GFR) within 15-60 mL/min
- Subjects on darbepoetin alfa for 3 months or more and with a stable entry hemoglobin level of 12 (plus or minus 1 g/dL
- range 11-13 g/dL)
- Subjects receiving darbepoetin alfa on an every two, three, or four week dosing schedule
Key exclusion criteria (6 listed)
- No uncontrolled high blood pressure as assessed by the primary physician
- No known hypersensitivity to mammalian cell-derived products
- No known hypersensitivity to human albumin
- Not receiving dialysis or scheduled to receive dialysis during the course of the study
- No severe congestive heart failure (New York Heart Association Class IV)
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
The primary objective was to evaluate the proportion of subjects who maintained hemoglobin levels within 10% of entry levels and/or a range of 11-13 g/dL for the 24-week duration of the study.
1 secondary outcome
The secondary objective was to evaluate safety in subjects with chronic kidney disease throughout the study
Results and safety
The study was stopped early (reason given: This study was stopped 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.
- Evaluation of Dose Conversion from Variable Dosing Intervals of Darbepoetin Alfa to Variable Dosing Intervals of Epoetin Alfa (PROCRIT) in Patients with the Anemia of Chronic Kidney DiseaseLink provided by the sponsor.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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 Chronic Renal Insufficiency, 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 6 inclusion and 6 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: This study was stopped 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?
The primary objective was to evaluate the proportion of subjects who maintained hemoglobin levels within 10% of entry levels and/or a range of 11-13 g/dL for the 24-week duration of the study.. 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.