Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis - MIRACLE-CKD

In a multicenter prospective observational study, Japanese NDCKD patients with an estimated glomerular filtration rate (eGFR) of >=6 mL/min/1.73 m2 and renal anemia (Hb <11 g/dL) treated with epoetin beta pegol (C.E.R.A.) for the first time were divided into 2 groups by Hb level (<11 g/dL or >=11 g/dL) in Week 12 of C.E.R.A. treatment (Week 12 Hb). Renal outcome was defined as time until first occurrence of one of the following: progression to renal replacement therapy, serum creatinine doubling, or eGFR falling below 6 mL/min/1.73 m2. The effect of Week 12 Hb on the onset of renal events was assessed by Kaplan-Meier and multivariate Cox regression analyses. In the landmark analysis included 2851 patients, Kaplan-Meier renal survival rate was 37.57% in the <11 g/dL group and was significantly higher (51.47%) in the >=11 g/dL group (P<0.0001). Multivariate Cox regression analysis revealed significantly higher risk of renal events in the <11 g/dL group than in the >=11 g/dL group (hazard ratio: 1.26; 95% confidence interval: 1.05-1.51; P=0.0103). The results suggest that Week 12 Hb levels >=11 g/dL achieved with C.E.R.A. treatment were associated with better renal outcomes than Hb levels <11 g/dL.