NCT00211068

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 124 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pure Red-cell Aplasia

Interventions

Type	Name	Description
DRUG	No intervention	This study is an observational study. No medication will be provided or administered to the participants. Participants will receive standard-of-care treatment from their individual physicians.

Timeline

• Start date: 2004-03-01
• Completion: 2006-03-01
• First posted: 2005-09-21
• Last updated: 2013-04-30

Locations

22 sites across 7 countries: Brazil, France, Norway, South Africa, Sweden, Thailand, United Kingdom