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A Study of Patients Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies

NCT ID: NCT00210977

Last Updated: 2013-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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

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Anemia

Keywords

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Anemia Erythropoietin Epoetin alfa Erythropoietin receptor agonist (ERA) therapy Anti-erythropoietin antibodies (anti-EPO Ab) Recombinant human erythropoietin Pure red cell aplasia Darbepoetin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type DRUG

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.

Interventions

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No intervention

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Other Identifiers

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EPO-IMU-302

Identifier Type: OTHER

Identifier Source: secondary_id

CR003277

Identifier Type: -

Identifier Source: org_study_id