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

Study Overview
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Brief Summary
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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
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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)

Official Title
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An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa

Conditions
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Chronic Kidney Disease, End-stage Renal Disease, Anaemia

Intervention / Treatment
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* Drug: Recombinant human erythropoietin alfa (biosimilar)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CKD5, renal anaemia, haemodialysis<br>CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar) | Drug: Recombinant human erythropoietin alfa (biosimilar)<br>* Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician<br>* Other names: biosimilar epoetin alfa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety. | 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. | Every month for 24 months + as occurring between visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, end-stage renal disease, renal anaemia, epoetin alfa