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).

Abstract

BACKGROUND:

Previous 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.

METHODS:

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 two 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 the 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 the Kaplan-Meier and multivariate Cox regression analyses.

RESULTS:

In the landmark analysis which 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).

CONCLUSIONS:

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.

• Authors: Terumasa Hayashi, Yukari Uemura, Michiko Kumagai, Masashi Kimpara, Hiroyuki Kanno, Yasuo Ohashi, MIRACLE-CKD Study Group
• Journal: Clinical and experimental nephrology (Clin Exp Nephrol) Vol. 23 Issue 3 Pg. 349-361 (Mar 2019) ISSN: 1437-7799 [Electronic] Japan
• PMID: 30291472 (Publication Type: Journal Article, Multicenter Study, Observational Study)

Chemical References

• Hemoglobins
• continuous erythropoietin receptor activator
• Erythropoietin
• Polyethylene Glycols

Topics

• Aged
• Aged, 80 and over
• Anemia (drug therapy)
• Erythropoietin (adverse effects, therapeutic use)
• Female
• Hemoglobins (analysis)
• Humans
• Kidney Failure, Chronic (mortality)
• Male
• Middle Aged
• Polyethylene Glycols (adverse effects, therapeutic use)
• Proportional Hazards Models
• Prospective Studies
• Renal Insufficiency, Chronic (blood, complications)