Clinical trial NCT00211068: A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pure Red-cell Aplasia
Keywords: Pure red-cell aplasia
Chronic kidney failure
Epoetin alfa (Eprex)
Erythropoietin
Kidney disease
Anemia
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants having chronic kidney disease and an immune-mediated cause of pure red cell aplasia indicated by the presence of anti-erythropoietin antibodies in their serum at the time of loss of efficacy

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.

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

Primary outcomes:
measure: Study medication-related risk factors: Number of participants who received Human Serum Albumin (HSA) containing drug
timeFrame: 1 year prior to the reference date
measure: Study medication-related risk factors: Number of participants who received HSA-free drug
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants who received epoetin alfa intravenously
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants who received epoetin alfa subcutaneously
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants who self-administered epoetin alfa
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants who administered epoetin alfa in hospital or in clinic
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants with the duration of epoetin alfa treatment
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants with the duration of other recombinant human erythropoietins (r-HuEPOs) treatment
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants with exposure to epoetin alfa
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants with exposure to other r-HuEPOs
timeFrame: 1 year prior to the reference date
measure: Study medication administration-related risk factors: Number of participants with frequency of epoetin alfa dosing
timeFrame: 6 months prior to the reference date
measure: Study medication administration-related risk factors: Number of participants with frequency of other r-HuEPOs dosing
timeFrame: 6 months prior to the reference date
measure: Participant-related risk factors: Number of participants according to age
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants according to sex
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants according to race
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants according to underlying diagnosis of chronic kidney disease
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants according to type of renal replacement therapy (if any at the time of the reference date)
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with history of malnutrition
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with history of autoimmune disease or positive results of autoimmune testing
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with history of immune dysregulation
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with uncontrolled hyperparathyroidism
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with uncontrolled hypothyroidism
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with history of malignancy
timeFrame: 5 years prior to the reference date
measure: Participant-related risk factors: Number of participants with history of viral infection
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with history of vaccination
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with immunosuppressive/immunomodulatory therapy
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with history of frequent transfusions
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with treatment with other subcutaneous medications
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants with treatment with other recombinant human proteins
timeFrame: 1 year prior to the reference date
measure: Participant-related risk factors: Number of participants who received other concomitant therapy
timeFrame: 1 year prior to the reference date
Secondary outcomes:
measure: Human leukocyte antigen (HLA) typing
timeFrame: 1 year prior to the reference date
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Bois Guillaume Cedex
country: France
city: Grenoble Cedex 1
country: France
city: Nantes Cedex 2
country: France
city: Orleans Cedex 2
country: France
city: Paris Cedex 20
country: France
city: Tvnsberg
country: Norway
city: Bloemfontein
country: South Africa
city: Karlshamn
country: Sweden
city: Stockholm N/A
country: Sweden
city: Trollhättan
country: Sweden
city: Vlissingen
country: Thailand
city: Birmingham
country: United Kingdom
city: Brighton
country: United Kingdom
city: Bristol
country: United Kingdom
city: Chelmsford
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Omagh N/A
country: United Kingdom
city: Westcliff-On-Sea
country: United Kingdom
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research and Development, L. L. C. Clinical trial
role: STUDY_DIRECTOR
References: