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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Chronic Kidney Disease; End-stage Renal Disease; Anaemia	Drug: Recombinant human erythropoietin alfa (biosimilar)

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 Design

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Study Type :	Observational
Actual Enrollment :	2086 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa
Study Start Date :	February 2010
Actual Primary Completion Date :	November 2014
Actual Study Completion Date :	November 2014

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
CKD5, renal anaemia, haemodialysis; CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar)	Drug: Recombinant human erythropoietin alfa (biosimilar); Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician; Other Name: biosimilar epoetin alfa

Outcome Measures

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Primary Outcome Measures :

1. 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. [ Time Frame: every month for 24 months ]

Secondary Outcome Measures :

1. Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety. [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with chronic kidney disease stage 5 with renal anemia and on haemodialysis

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 95 Study Locations

Sponsors and Collaborators

Sandoz

Hexal AG

Investigators

Study Chair:	HEXAL AG	Hexal AG

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gesualdo L, London G, Turner M, Lee C, Macdonald K, Goldsmith D, Covic A, Zaoui P, Combe C, Mann J, Dellanna F, Muenzberg M, Abraham I. A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study. Intern Emerg Med. 2013 Aug;8(5):389-99. doi: 10.1007/s11739-011-0622-7. Epub 2011 May 18.

Responsible Party:	Sandoz
ClinicalTrials.gov Identifier:	NCT01121237 History of Changes
Other Study ID Numbers:	HX575-503
First Posted:	May 12, 2010
Last Update Posted:	April 6, 2016
Last Verified:	April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Sandoz:

chronic kidney disease; end-stage renal disease; renal anaemia; epoetin alfa

Additional relevant MeSH terms:

Anemia; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hematologic Diseases	Urologic Diseases; Renal Insufficiency; Epoetin Alfa; Hematinics