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A Prospective, Immunogenicity Surveillance Registry of Erythropoiesis Stimulating Agent (ESA) With Subcutaneous Exposure in Thailand

NCT00799019 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 6500

Last updated 2014-01-29

No results posted yet for this study

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 with the medical indications. Subjects will be observed for the development of immunogenicity and PRCA for up to 3 years. Information on exposure to ESA products, ESA product handling and storage, and most recent hemoglobin level will be collected quarterly in the case report form. For cases of suspected PRCA, that sera specimen will be tested for EPO antibodies at Division of Nephrology, Chulalongkorn University Laboratory.

An Advisory Board (ADB) will periodically review blinded case data for subjects with unexplained loss of efficacy (LOE), identify cases of EPO antibody-mediated PRCA and will be responsible for data summary and make recommendations related to the incidence rate of PRCA associated with S.C. ESA use. The registry will provide no inducement to change therapy and will be non-interventional. The primary objective for this study is to estimate the incidence of anti-human Erythropoiesis and anti-EPO PRCA, develop in such patients. The diagnosis of PRCA by bone marrow biopsy must be prerequisite before the antibody assay. The secondary objective is to evaluate the efficacy of ESA for treatment of erythropoiesis deficiency anemia. Registry subjects will be adult men and women who are receiving or about to receive (within 1 month) a marketed ESA product by the s.c. route of administration at the time of enrollment. The marketed ESAs include innovative ESA and biosimilar ESA. Potential subjects will only be enrolled if they have been receiving an Erythropoiesis product for less than 1 year. Cases of EPO antibody-mediated PRCA will be determined by the clinical presence of essential criteria of unexplained LOE, administration of ESA product, bone marrow biopsy diagnosis of PRCA, and presence of EPO antibody. The sera of patients who meet all criteria will be assayed for neutralization.

Conditions

  • Erythropoietin

Sponsors & Collaborators

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Kearkiat Praditpornsilpa, MD · Chulalongkorn University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2013-12-31
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799019 on ClinicalTrials.gov