AnemiaNCT00210977
A Study of Patients Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies
An observational study of Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to assess the presence of anti erythropoietin antibodies (anti EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to treat or prevent anemia without loss of effectiveness to see if they will develop pure red cell aplasia or loss of effectiveness to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jan 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with positive or borderline serum anti erythropoietin antibody titer and who are responding to any erythropoietin receptor agonist (ERA) therapy for any cause of anemia
Who may be able to join
- Receiving any ERA therapy for any cause of anemia and having responded to the ERA therapy for at least 3 months
- Positive or borderline serum for antibodies to erythropoietin identified by serum radioimmunoprecipitation
- Maintained a stable hemoglobin within a 3-month period that has not decreased more than 2 g/dL in any 1-month period and with no increase in red blood cell transfusion requirement
- An ERA maintenance dose that has not increased more than 50 percentages from initial effective dose
- If blood count information is available, must have a count of reticulocytes (immature red blood cells) greater than or equal to 30 million/L
Who cannot join
- Stem cell or bone marrow transplantation
- Treatment with medication that decreases the ability of the immune system to function normally, within the last 3 months
- Participants who have shown a loss of effectiveness to ERA therapy, defined as participants who initially responded to treatment for anemia [a rise in hemoglobin which lasted for a minimum of 3 months] followed by an unexplained decrease in hemoglobin (greater than or equal to 2 g/dL) within a 1-month period
About this study
Official title: An Observational Study of Subjects Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies
The purpose of this study is to assess the presence of anti erythropoietin antibodies (anti EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to treat or prevent anemia without loss of effectiveness to see if they will develop pure red cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the duration of effectiveness of ERA therapy.
Read the detailed description
This is an observational (study in which the investigators/physicians observe the participant's data and measure their outcomes), international, multicenter (study conducted at multiple sites), cohort (group of individuals with similar characteristics) study. The study consists of prestudy phase, observational phase (2 years), and follow-up phase (1 year). Approximately 50 participants who already receiving ERA therapy for anemia will be observed in this study. In the observational phase, participants' erythropoietin antibody status (positive or negative), clinical progress, treatment for anemia or prevention of anemia, and outcome will be monitored. During this study, enrolled participants will continue to receive standard-of-care treatment for their disease from their individual investigators as before enrollment to this study. Safety evaluations will include assessment of adverse events which will be monitored throughout the study. The total duration of the study will be 3 years.
- Conditions
- Anemia
- Being tested
- No intervention
- Keywords
- Anemia, Erythropoietin, Epoetin alfa, Erythropoietin receptor agonist (ERA) therapy, Anti-erythropoietin antibodies (anti-EPO Ab), Recombinant human erythropoietin, Pure red cell aplasia, Darbepoetin
- Medical subject headings
- Anemia, Arthritis, Juvenile, Red-Cell Aplasia, Pure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
This is an observational study. All participants will be maintained on their regular dose regimen of standard-of-care treatment, under the guidance of the treating physician/investigator.
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin receptor agonist | Participants with borderline serum anti erythropoietin (EPO) antibody (Ab) titers and who are treated with any erythropoietin receptor agonist (ERA) for any indication, having anti-EPO Ab identified by radioimmunoprecipitation (RIP), who are responding to ERA therapy, will be included in the study. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Presence of Anti-Erythropoietin Antibodies (anti-EPO Ab)
An antibody is a large Y-shaped protein secreted into the blood and is used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. Presence of anti-EPO Ab will help to find out participant's progress to the outcomes loss of effectiveness, suspected pure red cell aplasia, or confirmed pure red cell aplasia.
Measured: Up to 2 years
Duration of Effectiveness of Erythropoietin Receptor Agonist Therapy
Measured: Up to 2 years
Secondary outcomes (5)
Concentration of Plasma Anti Erythropoietin Antibody
Measured: Up to 2 years
Factors That Forecast Progression to Loss of Effectiveness
Measured: Up to 2 years
Factors That Forecast Progression to Suspected Pure Red Cell Aplasia
Measured: Up to 2 years
Factors That Forecast Progression to Confirmed Pure Red Cell Aplasia
Measured: Up to 2 years
Number of Participants With Adverse Events
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Why it stopped: The study never started due to zero enrolment
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210977
- Sponsor's protocol ID
- CR003277
- Other IDs
- EPO-IMU-302
- Status last verified
- Aug 2013
- First submitted
- 13 Sep 2005
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Subjects Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies
- ClinicalTrials.gov ID
- NCT00210977
- Acronym / sponsor ID
- CR003277
- Conditions
- Anemia
- Keywords
- Anemia, Erythropoietin, Epoetin alfa, Erythropoietin receptor agonist (ERA) therapy, Anti-erythropoietin antibodies (anti-EPO Ab), Recombinant human erythropoietin, Pure red cell aplasia, Darbepoetin
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study never started due to zero enrolment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 21 Sep 2005 (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 the presence of anti erythropoietin antibodies (anti EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to treat or prevent anemia without loss of effectiveness to see if they will develop pure red cell aplasia or loss of effectiveness to recombinant erythropoietin and to measure the duration of effectiveness of ERA therapy.
Detailed description
This is an observational (study in which the investigators/physicians observe the participant's data and measure their outcomes), international, multicenter (study conducted at multiple sites), cohort (group of individuals with similar characteristics) study. The study consists of prestudy phase, observational phase (2 years), and follow-up phase (1 year). Approximately 50 participants who already receiving ERA therapy for anemia will be observed in this study. In the observational phase, participants' erythropoietin antibody status (positive or negative), clinical progress, treatment for anemia or prevention of anemia, and outcome will be monitored. During this study, enrolled participants will continue to receive standard-of-care treatment for their disease from their individual investigators as before enrollment to this study. Safety evaluations will include assessment of adverse events which will be monitored throughout the study. The total duration of the study will be 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin receptor agonist | – | Drug: No interventionParticipants with borderline serum anti erythropoietin (EPO) antibody (Ab) titers and who are treated with any erythropoietin receptor agonist (ERA) for any indication, having anti-EPO Ab identified by radioimmunoprecipitation (RIP), who are responding to ERA therapy, will be included in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with positive or borderline serum anti erythropoietin antibody titer and who are responding to any erythropoietin receptor agonist (ERA) therapy for any cause of anemia
Key inclusion criteria (5 listed)
- Receiving any ERA therapy for any cause of anemia and having responded to the ERA therapy for at least 3 months
- Positive or borderline serum for antibodies to erythropoietin identified by serum radioimmunoprecipitation
- Maintained a stable hemoglobin within a 3-month period that has not decreased more than 2 g/dL in any 1-month period and with no increase in red blood cell transfusion requirement
- An ERA maintenance dose that has not increased more than 50 percentages from initial effective dose
- If blood count information is available, must have a count of reticulocytes (immature red blood cells) greater than or equal to 30 million/L
Key exclusion criteria (3 listed)
- Stem cell or bone marrow transplantation
- Treatment with medication that decreases the ability of the immune system to function normally, within the last 3 months
- Participants who have shown a loss of effectiveness to ERA therapy, defined as participants who initially responded to treatment for anemia [a rise in hemoglobin which lasted for a minimum of 3 months] followed by an unexplained decrease in hemoglobin (greater than or equal to 2 g/dL) within a 1-month period
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 |
|---|---|---|
| No interventionThis is an observational study. All participants will be maintained on their regular dose regimen of standard-of-care treatment, under the guidance of the treating physician/investigator. | Drug | Erythropoietin receptor agonist |
Primary outcome
Number of Participants With Presence of Anti-Erythropoietin Antibodies (anti-EPO Ab)
Time frame: Up to 2 years
An antibody is a large Y-shaped protein secreted into the blood and is used by the immune system to identify and neutralize foreign objects such as bacteria and viruses. Presence of anti-EPO Ab will help to find out participant's progress to the outcomes loss of effectiveness, suspected pure red cell aplasia, or confirmed pure red cell aplasia.
Duration of Effectiveness of Erythropoietin Receptor Agonist Therapy
Time frame: Up to 2 years
5 secondary outcomes
Concentration of Plasma Anti Erythropoietin Antibody
Time frame: Up to 2 years
Factors That Forecast Progression to Loss of Effectiveness
Time frame: Up to 2 years
Factors That Forecast Progression to Suspected Pure Red Cell Aplasia
Time frame: Up to 2 years
Factors That Forecast Progression to Confirmed Pure Red Cell Aplasia
Time frame: Up to 2 years
Number of Participants With Adverse Events
Time frame: Up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2013.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 2 Sep 2013. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants With Presence of Anti-Erythropoietin Antibodies (anti-EPO Ab) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 2 Sep 2013.