Status:
UNKNOWN
A Prospective, Immunogenicity Surveillance Registry of Erythropoiesis Stimulating Agent (ESA) With Subcutaneous Exposure in Thailand
Lead Sponsor:
Chulalongkorn University
Collaborating Sponsors:
Ministry of Health, Thailand
Conditions:
Erythropoietin
Eligibility:
All Genders
18+ years
Brief Summary
This multicenter, immunogenicity surveillance registry employs a prospective, cohort design for patients who are using erythropoiesis stimulating agents (ESA)according to normal practice consistent wi...
Detailed Description
Incidence rates of EPO antibody-mediated PRCA will be estimated as the total number of cases of anti-Erythropoiesis and anti-EPO antibodies mediated PRCA attributed to a specific product presentation ...
Eligibility Criteria
Inclusion
- Be receiving or about to receive (within 1 month) a marketed erythropoiesis product by the s.c. route of administration
- Be 18 years of age or older
- Be likely to continue to receive s.c. erythropoiesis product(s) for at least 1 year
- Have read and signed the informed consent document for this registry indicating that they understand the purpose of and procedures required for the registry and are willing to participate in the registry.
Exclusion
- Potential subjects who meet any of the following criteria are excluded from the registry:
- Inability of the treating physician to obtain adequate follow-up information
- Have a history of PRCA or aplastic anemia
- Are experiencing unexplained loss or lack of effect (LOE) to a recombinant erythropoiesis product ongoing at the time of enrollment
- Have had prior recombinant erythropoiesis treatment whose anemia had never responded (primary lack of efficacy)
- Have a history of EPO antibodies prior to enrollment
- Are currently receiving immunosuppressive medication (e.g., cyclosporine, tacrolimus, sirolimus, mycophenolic mofetil, azathioprine, or monoclonal antibodies) and prednisolone.
- Have previously participated in this registry
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
6500 Patients enrolled
Trial Details
Trial ID
NCT00799019
Start Date
July 1 2008
End Date
June 1 2014
Last Update
January 29 2014
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