A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to collect historical occurrences of risk factors that are potentially associated with the development of anti-erythropoietin (EPO) antibody positive pure red cell aplasia (PRCA) in participants with chronic kidney disease who have been recently treated with epoetin alfa (EPREX).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Antibodies; Epoetin Alfa; Immunoglobulins

Criteria

Inclusion Criteria:

• History of anemia due to chronic kidney disease

• Pure red cell aplasia (PRCA) associated with erythropoietin-alpha (EPO) treatment

• Treatment with EPO for a minimum of 2 months occurring within more or less 3 months of the reference date (date of loss of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first observed)

Exclusion criteria

• History of and information related to past exposure to EPO not available

• History of PRCA or anti-EPO antibody positive status before or after the reference date