A Study of Patients Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies
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|ClinicalTrials.gov Identifier: NCT00210977|
Recruitment Status : Withdrawn (The study never started due to zero enrolment)
First Posted : September 21, 2005
Last Update Posted : September 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: No intervention||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||An Observational Study of Subjects Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies|
|Study Start Date :||December 2005|
|Estimated Primary Completion Date :||January 2010|
|Estimated Study Completion Date :||January 2010|
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.
Drug: 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.
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210977
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|