MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5

Launched by SANDOZ · May 10, 2010

Keywords

ClinConnect Summary

See the following publication:

Gesualdo, L., London, G., Turner, M., Lee, C., MacDonald, K., Covic, A., Zaoui, P., Combe, C., Dellana, F., Muenzberg, M., \& Abraham, I. (in press). A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anemia in hemodialysis patients: background and methodology of the MONITOR-CKD5 study. Internal and Emergency Medicine. (DOI 10.1007/511739-011-0622-7)

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female adults (age \> 18 years).
• • On chronic haemodialysis due to end-stage renal disease (CKD5) of original or grafted kidneys for any duration.
• • Diagnosed with renal anaemia; i.e., anaemia due to impaired production of endogenous erythropoietin secondary to kidney failure.
• • Treated with commercially available intravenous EPOETIN ALFA HEXAL® per physician's best clinical judgment and under consideration of available guidance and evidence.
• • Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
• • Informed written consent to participate in the study by patients or their legal guardian.
• Exclusion Criteria:
• • Known sensitivity to EPOETIN ALFA HEXAL® or any other ESA.
• • Solid or hematological neoplasia being treated with chemotherapy.
• • Treatment with any myelosuppressant medications.
• • Blood transfusion dependency.
• • History of pure red cell aplasia.
• • Bleeding episode in 30 days prior to enrollment.
• • Orthopaedic surgery in 30 days prior to enrollment.
• • Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
• • Patients with willfully negligent nonadherence to their haemodialysis, medication, nutrition, and/or other recommended treatment regimens.
• • Use of any investigational agent in the 30 days prior to enrollment.
• • Women of childbearing potential not using the contraception method(s) described above.
• • Women who are breastfeeding.