Trial Information

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

This is a multicenter (study conducted at multiple sites), case-control (study that compare
individuals with a disease or condition [cases] to a group of individuals without the
disease or condition [controls] to determine the possible factor which increased disease
incidence), retrospective (a study in which the participants are identified and then
followed backward, as time passes) study. Retrospective risk factor data will be collected
for control participants matched to the subset of participants in Protocol EPO-IMU-301
identified as having chronic kidney disease and anti-EPO antibody positive PRCA that began
while the participant was receiving treatment with EPREX (index participants). For each
index participant, up to 4 matched non-PRCA control participants with chronic kidney disease
will be enrolled in this study. Approximately 600 control participants will be enrolled in
this study. Control participants will be selected from the same site as the index
participant and the data will be collected from the date closest to the reference date (loss
of efficacy [drop in hemoglobin of greater than 2 g/dL/month] was first seen) that the
control participant satisfies all study inclusion and exclusion criteria. The optional
pharmacogenomic part (testing for polymorphisms and haploid types of the erythropoietin
gene) will be recorded for the control participants who will sign the pharmacogenomics part
of the study. No drug administration or treatment will be mandated by this study. Safety
evaluation will include assessment of adverse events.