3.5. Safety In total, 55 patients (19.7%) reported a total of 178 adverse events during the study. These included headache in two patients (0.7%) and hypertension in three patients (1.1%) (see Supplementary Table 1 in Supplementary Material available online at http://dx.doi.org/10.1155/2014/179705). Ten adverse events in seven patients (2.5%) were considered selleck chem Pazopanib by the investigator to be possibly, probably, or definitely related to C.E.R.A. These were hemolytic anemia, pancytopenia, thrombocytopenia, angina pectoris, unstable angina, deep vein thrombosis, hypertension (three patients), and injection site pain. Serious adverse events were reported in 32 patients (11.5%), with four out of 59 events having at least a possible relation with C.E.R.A. (angina pectoris, unstable angina, deep vein thrombosis, and hypertension in one patient each).

C.E.R.A. treatment was discontinued in three patients due to adverse events (hypertension; bone marrow depression; pancytopenia with hemolytic anemia) and in four patients due to serious adverse events (dialysis; sepsis with pneumonia, hemodialysis and renal failure; hypertension with angina pectoris; decreased hemoglobin with increased CRP). There were four deaths during the study, none of which had a suspected relation with C.E.R.A. administration. Mean (SD) eGFR remained unchanged during the study (study entry, 35.3 [16.6]mL/min/1.73m2; month 15, 34.4 [19.8]mL/min/1.73m2). No consistent pattern of change in serum ferritin concentration or TSAT was observed over the study period.

Abnormal erythrocyte counts, as identified by the physician as a clinical deviation from the normal, were reported in 46.7% of patients at the prestudy visit, 24.4% at visit 9, and 23.8% at visit 15. No difference in the rates of clinically significant abnormalities for leukocyte or thrombocyte counts was observed during the study versus prestudy. Other laboratory values including CRP, vitamin B12, and liver enzymes showed no clinically relevant changes during the study. Mean blood pressure remained unchanged from baseline (132/77mmHg) to month 15 (130/77mmHg). 4. Discussion In this observational study of maintenance kidney transplant patients with stable graft function, C.E.R.A. administered once a month according to local practice achieved a high degree of Hb stability. The main efficacy variable, Hb concentration of 11-12g/dL at each of the visits at months 7, 8, and 9, was achieved by 20.

7% of patients. During the evaluation period, the intrapatient Hb level varied by no more than 1g/dL in 87% of patients. Hb stability was achieved with a mean time between C.E.R.A. applications of 34 days and with patients self-administering Carfilzomib at least some injections in 90% of cases. Moreover, 43% of patients required no change in C.E.R.A. dose throughout the study. After a small early increase in mean Hb accounted for by C.E.R.A.