Status:
WITHDRAWN
A Study of Patients Treated With Erythropoietin Receptor Agonists for Anemia Who Developed Anti-erythropoietin Antibodies
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Eligibility:
All Genders
Brief Summary
The purpose of this study is to assess the presence of anti erythropoietin antibodies (anti EPO Ab) in participants responding to any erythropoietin receptor agonist (ERA) therapy to treat or prevent ...
Detailed Description
This is an observational (study in which the investigators/physicians observe the participant's data and measure their outcomes), international, multicenter (study conducted at multiple sites), cohort...
Eligibility Criteria
Inclusion
- Receiving any ERA therapy for any cause of anemia and having responded to the ERA therapy for at least 3 months
- Positive or borderline serum for antibodies to erythropoietin identified by serum radioimmunoprecipitation
- Maintained a stable hemoglobin within a 3-month period that has not decreased more than 2 g/dL in any 1-month period and with no increase in red blood cell transfusion requirement
- An ERA maintenance dose that has not increased more than 50 percentages from initial effective dose
- If blood count information is available, must have a count of reticulocytes (immature red blood cells) greater than or equal to 30 million/L
Exclusion
- Stem cell or bone marrow transplantation
- Treatment with medication that decreases the ability of the immune system to function normally, within the last 3 months
- Participants who have shown a loss of effectiveness to ERA therapy, defined as participants who initially responded to treatment for anemia \[a rise in hemoglobin which lasted for a minimum of 3 months\] followed by an unexplained decrease in hemoglobin (greater than or equal to 2 g/dL) within a 1-month period
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00210977
Start Date
December 1 2005
End Date
January 1 2010
Last Update
September 2 2013
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