Association between responsiveness to methoxy polyethylene glycol‐epoetin beta and renal survival in patients with non‐dialysis‐dependent chronic kidney disease: A pooled analysis of individual patient‐level data from clinical trials

Tsuruya, Kazuhiko; Uemura, Yukari; Hirakata, Hideki; Kitazono, Takanari; Tsubakihara, Yoshiharu; Suzuki, Masashi; Ohashi, Yasuo

doi:10.1111/nep.12842

Cited by 7 publications

(4 citation statements)

References 26 publications

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“…There are scattered reports of poor renal [1,3,12] and life prognosis [10] in patients with NDD-CKD whose anemia does not improve sufficiently with the use of ESA preparations, although it should be noted that these studies used different definitions of ESA hyporesponders. For the CERA administered in this study, a pooled analysis of clinical trials with this drug reported that it was associated with decreased renal survival in patients with ESA hyporesponse, consistent with results with conventional ESA preparations [13]. In the trial whose dataset was analyzed here [8], there was no predominant difference in the incidence of renal prognostic events, including renal replacement therapy, between the intensive ESA treatment group and the conservative treatment groups.…”

Section: Discussionsupporting

confidence: 78%

Predictors of Hyporesponsiveness to Erythropoiesis-Stimulating Agents in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (RADIANCE-CKD Study)

Mase,

Yamagata,

Yamamoto

et al. 2023

Am J Nephrol

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Introduction: Hyporesponsiveness to erythropoiesis-stimulating agents (ESA) has been associated with increased mortality and cardiovascular events in patients with chronic kidney disease. We hypothesized that the prediction of ESA resistance when ESA administration would be very useful in deciding on a treatment plan. Methods: Patients enrolled in a randomized controlled trial to evaluate renal prognosis in anemic patients with non-dialysis-dependent chronic kidney disease with hyporesponsiveness to ESA were included; the patients had different target hemoglobin levels. A landmark analysis was performed at 3 months into the study. To construct a predictive model for the severe ESA hypo-responder group, in which there was no increase in hemoglobin even with active treatment, background factors and serum test items that affect anemia at study entry were included in a logistic regression model, the area under the curve (AUC) and 95% confidence intervals (CI) were estimated, and sensitivity and specificity were calculated. This study was a post-hoc sub-analysis of a randomized controlled trial. Results: The AUC for the 19 existing risk factors as predictors was 0.783 (95% CI; 0.711–0.855). Among the 19 risk factors, the combination of six factors (hemoglobin level, systolic blood pressure, weight, gender, smoking status and hypertensive retinopathy) with the largest χ-square statistics were selected by multiple logistics regression. The AUC for these 6 predictors was 0.716 (95% CI: 0.634-0.799). To the six existing risk factors, five serum test items that affecting anemia (vitamin B12, vitamin B6, folic acid, parathyroid hormone, and 25-hydroxyvitamin D) were added, for a total of 11 risk factors, with a similar AUC of 0.736 (95% CI; 0.655–0.817), sufficient to predict ESA resistance. Conclusions: Our results suggest that existing risk factors and serum test items can be used to predict ESA resistance in patients with non-dialysis-dependent chronic kidney disease on ESA.

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Section: Discussionsupporting

confidence: 78%

Predictors of Hyporesponsiveness to Erythropoiesis-Stimulating Agents in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (RADIANCE-CKD Study)

Mase,

Yamagata,

Yamamoto

et al. 2023

Am J Nephrol

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“…They divided patients into two groups based on median erythropoietin resistance index (ERI) in Week 12 of C.E.R.A. treatment, as a measure of ESA responsiveness, and found that renal outcome (initiation of dialysis or 30% decrease in eGFR) was significantly poorer in the poor-response group compared to the good-response group [17]. Our study did not investigate ERI, but the C.E.R.A.…”

Section: Discussionmentioning

confidence: 98%

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)

Hayashi

Uemura

Kumagai³

et al. 2018

Clin Exp Nephrol

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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 m 2 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 m 2 . 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. Electronic supplementary material The online version of this article (10.1007/s10157-018-1649-0) contains supplementary material, which is available to authorized users.

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“…Second, the observational period was only 48 weeks, and we could not evaluate the long-term outcomes and prognosis. Several studies have reported that ESA responsiveness is associated with long-term prognosis in HD patients or renal survival in CKD patients [32,33]. Hence, follow-up of these PD patients for a more extended period could provide further insights.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of continuous erythropoietin receptor activator for end-stage renal disease patients with renal anemia before and after peritoneal dialysis initiation

et al. 2020

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Background Serial management of renal anemia using continuous erythropoietin receptor activator (CERA) throughout the peritoneal dialysis initiation period has rarely been reported. We investigated the efficacy and dosage of CERA treatment from pre- to post-peritoneal dialysis initiation for anemia management in patients with end-stage renal disease. Methods Twenty-six patients (13 men; mean age 60.9 years) who started peritoneal dialysis between April 2012 and April 2018 were investigated. Serial changes in hemoglobin levels, transferrin saturation and ferritin levels, CERA dosage, and the erythropoietin resistance index (ERI) over a 48 week period were retrospectively examined. Results Mean hemoglobin levels increased significantly from 10.5 g/dL at 24 weeks prior to the peritoneal dialysis initiation to 11.5 g/dL at 4 weeks post-initiation. The proportion of patients with hemoglobin levels ≥ 11 g/dL increased significantly after peritoneal dialysis initiation. The mean CERA dosage was 57.0 µg/month at 24 weeks prior to dialysis initiation, 86.5 µg/month at initiation, and 72.0 µg/month at 4 weeks post-initiation. Thus, the dosage tended to increase immediately before peritoneal dialysis initiation and then decreased thereafter. Hemoglobin levels were significantly lower, while the CERA dosage for maintaining hemoglobin levels and ERI tended to be higher at dialysis initiation in patients with diabetes than in those without diabetes. Conclusion Treatment with CERA prior to and during the peritoneal dialysis initiation achieved fairly good anemia management in patients with and without diabetes. The CERA dosage could be reduced in patients without diabetes after dialysis initiation.

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Association between responsiveness to methoxy polyethylene glycol‐epoetin beta and renal survival in patients with non‐dialysis‐dependent chronic kidney disease: A pooled analysis of individual patient‐level data from clinical trials

Cited by 7 publications

References 26 publications

Predictors of Hyporesponsiveness to Erythropoiesis-Stimulating Agents in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (RADIANCE-CKD Study)

Predictors of Hyporesponsiveness to Erythropoiesis-Stimulating Agents in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (RADIANCE-CKD Study)

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)

Efficacy of continuous erythropoietin receptor activator for end-stage renal disease patients with renal anemia before and after peritoneal dialysis initiation

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