A Study of Patients 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Observational Study of Subjects Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies|
- Number of Participants With Presence of Anti-Erythropoietin Antibodies (anti-EPO Ab) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Concentration of Plasma Anti Erythropoietin Antibody [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Factors That Forecast Progression to Loss of Effectiveness [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Factors That Forecast Progression to Suspected Pure Red Cell Aplasia [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Factors That Forecast Progression to Confirmed Pure Red Cell Aplasia [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Number of Participants With Adverse Events [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Blood samples will be collected for pharmacogenomic analysis.
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.
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 Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|