E.R.A. was initiated. 2.3. Medication Prior to study entry, any ESA therapy was administered by the physician according to local practice and the summary of product characteristics of the selected ESA. All patients received C.E.R.A. therapy from study entry, prescribed according to local practice. 2.4. Evaluation Study visits were scheduled to take place at study entry and once selleck kinase inhibitor a month throughout the 15-month observation period, with a minimum of fifteen postbaseline visits. For patients enrolled prior to extension of the study to 15 months, a minimum of nine postbaseline visits were required. At study entry, the following data were collected: demographics, type of transplant, time since transplantation, duration and regimen of previous ESA therapy, baseline Hb concentration prior to C.E.R.

A. administration, additional laboratory values (iron status, blood count, liver function, estimated glomerular filtration rate (eGFR), C-reactive protein (CRP) and vitamin B12 concentrations), and concomitant disease/medication. Subsequent study visits included recording of Hb value prior to C.E.R.A. administration, collection of additional laboratory data, and changes in concomitant disease/medication. GFR was estimated using the abbreviated four-variable Modification of Diet in Renal Disease (MDRD [36]) formula. Adverse events were documented, including duration, severity, whether the event was regarded as serious, and causal relationship with C.E.R.A.

Serious adverse events were defined as those which were life-threatening or fatal, required unplanned hospitalization or prolonged hospitalization, resulted in persistent or significant disability or incapacity, or were regarded as an important medical event. Additionally, a decrease in Hb concentration of >2g/dL, any occurrence of pure red cell aplasia or production of anti-epoetin antibodies was to be handled as serious adverse drug reactions of special interest. Data were recorded by study investigators on printed forms and checked at the participating center for completeness, and then entered independently to a database by an independent research organization (M.A.R.C.O. GmbH & Co KG, 40227 D��sseldorf, Germany) which was also responsible for clarifying discrepancies on the submitted forms. 2.5. Statistical Analysis The main efficacy variable was the proportion of patients (��responders��) achieving an Hb concentration of 11-12g/dL at each of visits 7, 8, and 9, that is, after a 7�C9 month period for C.

E.R.A. dose titration. Following extension of the study to a 15-month observation period, the proportion of patients within each of these two Hb ranges was also calculated for the periods covering months 7 to 12 and months 7 to 15. In additional prespecified analyses, the Brefeldin_A proportion of patients within the Hb ranges 10�C12, 10�C13g/dL and 11�C13g/dL were also calculated for each of these time periods.