The corresponding values for BPAR were 78.4% and 83.6% (P = 0.46, log selleck chemical rank test) (Figure 2(b)). Figure 2 Kaplan-Meier estimates of the probability of remaining free from (a) treatment failure (BPAR (central review), graft loss, death, or loss to follow-up) or (b) BPAR. Table 3 Efficacy endpoints at month 36, n (%). Between month 6 and month 36, the rate of treatment failure was 12.9% (9/70) in the steroid avoidance group and 13.1% (8/61) in the steroid withdrawal group. BPAR occurred in 7 and 4 patients, respectively. All episodes were graded IA or IB except one episode in the steroid withdrawal group which was graded IIA (Table 3). One graft was lost in the steroid avoidance group due to a transplantectomy for perirenal hematoma compression.

Two patients died in each group, due to metastatic bronchial carcinoma and unknown causes in the steroid avoidance group, and epidermoid cancer and multiorgan failure syndrome in the steroid withdrawal group. Renal function did not differ between the two groups during the study. Mean (SD) eGFR (MDRD) was not significantly different at month 6 after transplant (steroid avoidance 53.2 [17.6]mL/min/1.73m2 versus steroid withdrawal 55.8 [21.1]mL/min/1.73m2; P = 0.66) and at month 36 (49.9 [19.1]mL/min/1.73m2 versus 55.1 [20.0]mL/min/1.73m2; P = 0.10) (Figure 3). Similar findings were observed when renal function was assessed by calculated creatinine clearance (Cockcroft-Gault formula) or when eGFR was estimated by the Nankivell formula (data not shown). Mean proteinuria was also similar between groups at month 6 (0.3 �� 0.

4g/mmol in the steroid avoidance group versus 0.4 �� 0.5g/mmol in the steroid withdrawal groups; P = 0.56) and month 36 (0.5 �� 1.0g/mmol versus 0.4 �� 0.5g/mmol; P = 0.68). Figure 3 Estimated GFR (MDRD) during months 6 to 36. Values are shown as mean (SD). GFR: glomerular filtration rate; MDRD: Modification of Diet in Renal Disease; SD: standard deviation. 3.4. Adverse Events Almost all patients reported at least one adverse event during the follow-up study (months 6 to 36), with no difference between treatment groups (steroid avoidance 69/70 (98.6%), steroid withdrawal 60/62 (96.8%); P = 0.60). The most frequent adverse events were dyslipidemia, diarrhea, peripheral edema, and urinary tract infection (14.3%, 18.6%, 18.6%, and 12.9% in the steroid avoidance group, respectively, and 24.2%, 19.

4%, 16.1%, and 16.1% in the steroid withdrawal group), the incidence of which did not differ significantly between groups. Serious adverse events were reported in 34 steroid avoidance patients and 33 steroid withdrawal patients (48.6% versus 53.2%, P = 0.52). The incidence of adverse events Entinostat with a suspected relation to steroids during months 6�C36 was 22.9% (16/70) and 37.1% (23/62) in the steroid avoidance and steroid withdrawal groups, respectively (P = 0.062).