Background: Anemia is a risk factor for death, adverse cardiovascular outcomes and poor quality of life in patients with\r\nchronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are commonly used to increase hemoglobin\r\nlevels in this population. In observational studies, higher hemoglobin levels (around 11-13 g/dL) are associated with\r\nimproved survival and quality of life compared to hemoglobin levels around 9-10 g/dL. A systematic review of\r\nrandomized trials found that targeting higher hemoglobin levels with ESA causes an increased risk of adverse vascular\r\noutcomes. It is possible, but has never been formally tested in a randomized trial, that ESA dose rather than targeted\r\nhemoglobin concentration itself mediates the increased risk of adverse vascular outcomes. The Clinical Evaluation of\r\nthe DOSe of Erythropoietins (C.E. DOSE) trial will assess the benefits and harms of a high versus a low fixed ESA dose for\r\nthe management of anemia in patients with end stage kidney disease.\r\nMethods/Design: This is a randomized, prospective open label blinded end-point (PROBE) trial due to enrol 2204\r\nhemodialysis patients in Italy. Patients will be randomized 1:1 to 4000 IU/week versus 18000 IU/week of intravenous\r\nepoietin alfa or beta, or any other ESA in equivalent doses. The dose will be adjusted only if hemoglobin levels fall\r\noutside the 9.5-12.5 g/dL range. The primary outcome will be a composite of all-cause mortality, non fatal stroke, non\r\nfatal myocardial infarction and hospitalization for cardiovascular causes. Quality of life and costs will also be assessed.\r\nDiscussion: The C.E.DOSE study will help inform the optimal therapeutic strategy for the management of anemia of\r\nhemodialysis patients, improving clinical outcomes, quality of life and costs, by ascertaining the potential benefits and\r\nharms of different fixed ESA doses.
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