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

NCT ID: NCT00211068

Last Updated: 2013-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 124 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2006-03-31

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.

Conditions

Pure Red-cell Aplasia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No intervention

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

EPREX

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial

Role: STUDY_DIRECTOR

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

Locations

São Paulo, , Brazil

Sorocaba, , Brazil

Bois-Guillaume, , France

Grenoble, , France

Nantes, , France

Orléans, , France

Paris, , France

Tvnsberg, , Norway

Bloemfontein, , South Africa

Karlshamn, , Sweden

Stockholm, , Sweden

Trollhättan, , Sweden

Vlissingen, , Thailand

Birmingham, , United Kingdom

Brighton, , United Kingdom

Bristol, , United Kingdom

Chelmsford, , United Kingdom

Edinburgh, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Omagh, , United Kingdom

Westcliff-on-Sea, , United Kingdom

Countries

Brazil; France; Norway; South Africa; Sweden; Thailand; United Kingdom

Other Identifiers

EPO-IMU-403

Identifier Type: OTHER

Identifier Source: secondary_id

CR004408

Identifier Type: -

Identifier Source: org_study_id