Status:
COMPLETED
A Study of Risk Factors for Anti-erythropoietin Antibody Positive Pure Red Cell Aplasia Among Patients With Chronic Kidney Disease Receiving Epoetin Alfa
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Pure Red-cell Aplasia
Eligibility:
All Genders
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00211068
Start Date
March 1 2004
End Date
March 1 2006
Last Update
April 30 2013
Active Locations (22)
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1
São Paulo, Brazil
2
Sorocaba, Brazil
3
Bois-Guillaume, France
4
Grenoble, France