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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Collaborator: Hexal AG
• Treatments: Epoetin Alfa

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.