All analyses are presented descriptively. Confidence intervals are reported where appropriate. Efficacy analyses were performed in the efficacy population, defined as all patients who provided at least one measurement of Hb concentration and http://www.selleckchem.com/products/Romidepsin-FK228.html received at least one dose of C.E.R.A. during months 7�C9 of the study, did not receive any ESA therapy other than C.E.R.A. during the study, met the inclusion/exclusion criteria as confirmed in writing by the investigator, and did not have other major protocol violations. Safety analyses were performed on all patients who received at least one dose of C.E.R.A. For patients in whom C.E.R.A. therapy was terminated before the end of the observation period, data were analyzed to the point of discontinuation. 3. Results 3.1.

Patient Population In total, 290 patients were enrolled to the study. Of these, 11 did not receive C.E.R.A. such that the safety population comprised 279 patients. The efficacy population included 193 patients, with exclusion most frequently due to absence of C.E.R.A. dosing and/or a missing Hb concentration during months 7�C9. In total, 186 patients in the efficacy population completed month 9 and 138 completed month 15. Ninety-four patients discontinued the study prematurely (Figure 1) and 49 stopped C.E.R.A. therapy prematurely, most frequently due to patients’ request (17/49). Other frequent reasons were the requirement to start dialysis (n = 22) and administration of another ESA (n = 17) (Figure 1). The mean time between study visits was 35.3 (41.6) days. Figure 1 Patient disposition.

The mean age was approximately 51 years, and approximately half the patients were male (Table 1). The mean (SD) eGFR was 35.3 (16.6)mL/min/1.73m2. Table 1 Patient demographics and baseline characteristics at study entry (safety population, n = 279). Data on immunosuppressive therapy was available for only 43/279 patients (15.4%), including mycophenolic acid (n = 24), an mTOR inhibitor (n = 18), and a calcineurin inhibitor (n = 22). 3.2. Iron Status Iron deficiency, defined as serum ferritin < 100ng/mL or TSAT < 20%, was present in 26 of the 126 patients for whom data were available at study entry (20.6%). Mean (SD) serum ferritin at study entry was 198 (523)ng/mL (median 72ng/mL, interquartile range 26�C179ng/mL [n = 111]), and mean (SD) TSAT was 28.3 (11.2)% (median 28%, interquartile range 20�C35% [n = 106]). Use of iron therapy was reported in 74/279 patients in the safety set (26.5%), most frequently ferrous sulfate (n = 51) or iron sucrose (n = 15). 3.3. Previous ESA Therapy and C.E.R.A. Administration Four-fifths of the population (224/279, 80.3%) were receiving ESA therapy at the time of study entry, most frequently Anacetrapib darbepoetin alfa (n = 98, 35.1%) or C.E.R.A. (n = 45, 16.1%) (Table 1).