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

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.0 sites124 target enrollmentMarch 2004

ConditionsPure Red-cell Aplasia

InterventionsNo intervention

DrugsNo intervention

Overview

Phase: Not Applicable
Intervention: No intervention
Conditions: Pure Red-cell Aplasia
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Enrollment: 124
Primary Endpoint: Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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).

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

March 2006

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility 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

Exclusion Criteria

Not provided

Arms & Interventions

Epoetin alfa

Four control patients will be matched to each index patients enrolled in protocol EPO-IMU-301 identified as having chronic kidney disease and an immune-mediated cause of pure red cell aplasia (PRCA) indicated by the presence of anti-erythropoietin (EPO) antibodies in their serum at the time of loss of efficacy.

Intervention: No intervention

Outcomes

Primary Outcomes

Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug