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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 主要终点
- Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: No intervention (Drug)
结局指标
主要结局
Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug
时间窗: 1 year prior to the reference date
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.
Study medication-related risk factors: Number of participants who received HSA-free drug
时间窗: 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
时间窗: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously
时间窗: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa
时间窗: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing
时间窗: 6 months prior to the reference date
Participant-related risk factors: Number of participants according to age
时间窗: 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)
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of viral infection
时间窗: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously
时间窗: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa
时间窗: 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
时间窗: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing
时间窗: 6 months prior to the reference date
Participant-related risk factors: Number of participants according to sex
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of malnutrition
时间窗: 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
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with uncontrolled hypothyroidism
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with treatment with other recombinant human proteins
时间窗: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment
时间窗: 1 year prior to the reference date
Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of malignancy
时间窗: 5 years prior to the reference date
Participant-related risk factors: Number of participants according to race
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of immune dysregulation
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of vaccination
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with history of frequent transfusions
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants with treatment with other subcutaneous medications
时间窗: 1 year prior to the reference date
Participant-related risk factors: Number of participants who received other concomitant therapy
时间窗: 1 year prior to the reference date
次要结局
- Human leukocyte antigen (HLA) typing(1 year prior to the reference date)