An observational study in Chronic Kidney Disease, End-stage Renal Disease and Anaemia, sponsored by Sandoz. Completed at 95 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Sandoz · Observational
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.
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)
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 2,086 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Patients with chronic kidney disease stage 5 with renal anemia and on haemodialysis
Exclusion Criteria:
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
Also known as: biosimilar epoetin alfa
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
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.
Time frame: Every month for 24 months + as occurring between visits
Plan to share: Undecided
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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