Effect of achieved hemoglobin level on renal outcome in non-dialysis chronic kidney disease (CKD) patients receiving epoetin beta pegol: MIRcerA CLinical Evidence on Renal Survival in CKD patients with renal anemia (MIRACLE-CKD Study)

BackgroundPrevious randomized-controlled trials have shown that targeting higher hemoglobin (Hb) levels using high dose of ESA in non-dialysis chronic kidney disease (NDCKD) patients resulted in poorer cardiovascular outcome; however, it remains unknown how high Hb levels achieved by ESA in clinical practice dose could affect renal outcome.MethodsIn a multicenter prospective observational study, Japanese NDCKD patients with an estimated glomerular filtration rate (eGFR) of 6mL/min/1.73m(2) and renal anemia (Hb<11g/dL) treated with epoetin beta pegol (C.E.R.A.) for the first time were divided into two groups by Hb level (<11g/dL or 11g/dL) in Week 12 of C.E.R.A. treatment (Week 12 Hb). Renal outcome was defined as time until the first occurrence of one of the following: progression to renal replacement therapy, serum creatinine doubling, or eGFR falling below 6mL/min/1.73m(2). The effect of Week 12 Hb on the onset of renal events was assessed by the Kaplan-Meier and multivariate Cox regression analyses.ResultsIn the landmark analysis which included 2851 patients, Kaplan-Meier renal survival rate was 37.57% in the <11g/dL group and was significantly higher (51.47%) in the 11g/dL group (P<0.0001). Multivariate Cox regression analysis revealed significantly higher risk of renal events in the <11g/dL group than in the 11g/dL group (hazard ratio: 1.26; 95% confidence interval: 1.05-1.51; P=0.0103).ConclusionsThe results suggest that week 12 Hb levels11g/dL achieved with C.E.R.A. treatment were associated with better renal outcomes than Hb levels<11g/dL.