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

Completed

• Conditions: Chronic Kidney Disease; End-stage Renal Disease; Anaemia
• Interventions: Drug: Recombinant human erythropoietin alfa (biosimilar)

• Registration Number: NCT01121237
• Lead Sponsor: Sandoz

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2086

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CKD5, renal anaemia, haemodialysis	Recombinant human erythropoietin alfa (biosimilar)	CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar)

Primary Outcome Measures

Name	Time	Method
Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels.	every month for 24 months

Secondary Outcome Measures

Name	Time	Method
Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety.	Every month for 24 months + as occurring between visits	Safety will be assessed every month for 24 months. In addition, any safety events reported by the patient or observed by clinicians in-between the monthly assessments will be recorded at the time of report or occurrence, and will be addressed at that time as necessary.

Trial Locations

Locations (1)

Sandoz Investigational Site; 🇬🇧 Plymouth, United Kingdom