Overview

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.