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).
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.
Study Type
OBSERVATIONAL
Enrollment
124
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.
Unnamed facility
São Paulo, Brazil
Unnamed facility
Sorocaba, Brazil
Unnamed facility
Bois-Guillaume, France
Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug
The reference date is the day on which Loss of Efficacy (LOE) was first suspected, where LOE is the date that a drop in hemoglobin of greater than 2 g/dL/month was first seen.
Time frame: 1 year prior to the reference date
Study medication-related risk factors: Number of participants who received HSA-free drug
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who administered epoetin alfa in hospital or in clinic
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with the duration of other recombinant human erythropoietins (r-HuEPOs) treatment
Time frame: 1 year prior to the reference date
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Unnamed facility
Grenoble, France
Unnamed facility
Nantes, France
Unnamed facility
Orléans, France
Unnamed facility
Paris, France
Unnamed facility
Tvnsberg, Norway
Unnamed facility
Bloemfontein, South Africa
Unnamed facility
Karlshamn, Sweden
...and 12 more locations
Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs
Time frame: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing
Time frame: 6 months prior to the reference date
Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing
Time frame: 6 months prior to the reference date
Participant-related risk factors: Number of participants according to age
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to sex
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to race
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to type of renal replacement therapy (if any at the time of the reference date)
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of malnutrition
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of autoimmune disease or positive results of autoimmune testing
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of immune dysregulation
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with uncontrolled hypothyroidism
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of malignancy
Time frame: 5 years prior to the reference date
Participant-related risk factors: Number of participants with history of viral infection
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of vaccination
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of frequent transfusions
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with treatment with other subcutaneous medications
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants with treatment with other recombinant human proteins
Time frame: 1 year prior to the reference date
Participant-related risk factors: Number of participants who received other concomitant therapy
Time frame: 1 year prior to the reference date
Human leukocyte antigen (HLA) typing
The optional pharmacogenomic (use of genetic information to predict whether the study medication will help make a patient well or ill) part of the study will test for polymorphisms and haploid types of the erythropoietin gene. HLA typing will be recorded for the control participants who will sign the pharmacogenomics part of the study.
Time frame: 1 year prior to the reference date