Status:
COMPLETED
Study to Monitor the Incidence of Pure Red Cell Aplasia (PRCA) and/or Antibodies to Erythropoietin Among Participants Receiving Epoetin Alfa or Another Erythropoietin
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Red-Cell Aplasia, Pure
Chronic Renal Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to assess the incidence of pure red cell aplasia (PRCA \[suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production\]) among participa...
Detailed Description
This is a prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the stud...
Eligibility Criteria
Inclusion
- Male or female participants of legal age to give consent according to local standards
- Participants must be receiving or about to receive treatment with an erythropoietin as part of a pre-existing treatment plan for their chronic renal (or other) disease
- Physicians treating the participants must agree in advance to document any appearance of pure red cell aplasia (PRCA) such that information and details of the case may be reported to regulatory agencies (with patient identification protected)
- If required by local ethics committees, participants must give consent to permit the collection of de-identified personal data for the specific purpose of this study and to collect blood samples for tests for antibodies to erythropoietin
Exclusion
- Participants who are unable to complete future follow-up visits
- Participants who when entering the study have any of the following symptoms of pure red cell aplasia (PRCA): Loss of effectiveness of erythropoietin or low number of immature red blood cells while on erythropoietin as shown by a blood test or bone marrow examination
- Participants with a history of PRCA or loss of effectiveness with erythropoietin at the time of enrollment into the study
- Participants whose anemia did not respond to previous treatment with an erythropoietin
- Participants with a history of antibodies to erythropoietin prior to entering the study
Key Trial Info
Start Date :
May 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
4761 Patients enrolled
Trial Details
Trial ID
NCT00210951
Start Date
May 1 2003
End Date
July 1 2005
Last Update
March 24 2015
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