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

Condition(s) targeted: Pure Red-cell Aplasia

Intervention: No intervention (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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).

Official title: 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

Study design: Observational Model: Case Control, Time Perspective: Retrospective

Primary outcome:

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

Study medication-related risk factors: Number of participants who received HSA-free drug

Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously

Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously

Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa

Study medication administration-related risk factors: Number of participants who administered epoetin alfa in hospital or in clinic

Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment

Study medication administration-related risk factors: Number of participants with the duration of other recombinant human erythropoietins (r-HuEPOs) treatment

Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa

Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs

Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing

Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing

Participant-related risk factors: Number of participants according to age

Participant-related risk factors: Number of participants according to sex

Participant-related risk factors: Number of participants according to race

Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease

Participant-related risk factors: Number of participants according to type of renal replacement therapy (if any at the time of the reference date)

Participant-related risk factors: Number of participants with history of malnutrition

Participant-related risk factors: Number of participants with history of autoimmune disease or positive results of autoimmune testing

Participant-related risk factors: Number of participants with history of immune dysregulation

Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism

Participant-related risk factors: Number of participants with uncontrolled hypothyroidism

Participant-related risk factors: Number of participants with history of malignancy

Participant-related risk factors: Number of participants with history of viral infection

Participant-related risk factors: Number of participants with history of vaccination

Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy

Participant-related risk factors: Number of participants with history of frequent transfusions

Participant-related risk factors: Number of participants with treatment with other subcutaneous medications

Participant-related risk factors: Number of participants with treatment with other recombinant human proteins

Participant-related risk factors: Number of participants who received other concomitant therapy

Secondary outcome: Human leukocyte antigen (HLA) typing

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Sao Paulo, Brazil

Sorocaba, Brazil

Bois Guillaume Cedex, France

Grenoble Cedex 1, France

Nantes Cedex 2, France

Orleans Cedex 2, France

Paris Cedex 20, France

Tvnsberg, Norway

Bloemfontein, South Africa

Karlshamn, Sweden

Stockholm N/A, 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 N/A, United Kingdom

Westcliff-On-Sea, United Kingdom

Starting date: March 2004
Last updated: April 29, 2013