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

Sandoz

Status: Completed

Conditions: Chronic Kidney Disease; Anaemia; End-stage Renal Disease

Treatments: Drug: Recombinant human erythropoietin alfa (biosimilar)

Study type: Observational

Funder types: Industry

Identifiers

NCT01121237

HX575-503

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 2,086 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,086 participants in 1 patient group

CKD5, renal anaemia, haemodialysis

Description:

CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar)

Treatment:

Drug: Recombinant human erythropoietin alfa (biosimilar)