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During the congress, E-Posters will be accessible to all participants on the congress website 24/7, as well as in the E-poster stations in the congress center.
Preparing your E-Poster
Please review the E-Poster format requirements carefully when preparing your E-Poster. Should your E-Poster not meet the mentioned requirements, it may not be displayed as described above.
E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
Please follow the instructions below to input your abstract title.
Abstract titles should be brief and reflect the content of the abstract.
Erythropoiesis-Stimulating Agents (ESAs) are the cornerstone of therapy for anemia in patients with chronic kidney disease (CKD). Efepoetin alfa, a novel long-acting erythropoietin (EPO)-hybrid Fc fusion protein, was previously shown to be non-inferior to methoxy polyethylene glycol-epoetin beta (mPEG-epoetin beta) for the treatment of anemia in CKD in a pivotal phase 3 trial. The management of anemia in CKD patients with co-existing diabetes mellitus presents a distinct clinical challenge, as this population often exhibits greater difficulty in achieving and maintaining target hemoglobin (Hb) levels compared to non-diabetic counterparts. This post-hoc analysis of a phase 3 non-inferiority trial (NCT04155125) was conducted to evaluate the efficacy of long-acting ESAs specifically within the subpopulation of anemic CKD patients with diabetes.
This analysis utilized data from the per-protocol (PP) population of the aforementioned phase 3 trial. The presence of diabetes mellitus was determined from each subject’s recorded medical history. The analysis included two treatment arms: efepoetin alfa administered once every two weeks (Q2W) and mPEG-epoetin beta Q2W. The efepoetin alfa arm consisted of 118 patients with diabetes and 53 patients without diabetes. The mPEG-epoetin beta arm included 115 patients with diabetes and 54 patients without diabetes. The primary efficacy endpoint was the Hb responder rate, defined as an increase in Hb of ≥1 g/dL from baseline and a mean Hb concentration within the 10–12 g/dL range, inclusive, without requiring a blood transfusion during the evaluation period. The statistical significance of the difference in responder rates between diabetic and non-diabetic patients was determined using the Chi-squared test.
Hb responder rate for overall PP population in phase 3 clinical trial was 75.6% (95% CI: 69.2, 82.0) and 69.3% (95% CI: 62.5, 76.1) for efepoetin alfa Q2W and mPEG-epoetin beta Q2W group, respectively.
Hb responder rate in diabetic patients was 77.12% (95% CI: 69.54, 84.70) for efepoetin alfa Q2W group, and 68.69% (95% CI: 60.22, 77.17) for mPEG-epoetin beta Q2W group.
Differences of 3.53% (95% CI: -9.49, 18.28) and 5.38% (95% CI: -9.76, 18.66) were observed when comparing the Hb responder rate between diabetic and non-diabetic patients in efepoetin alfa and mPEG-epoetin beta, respectively. CI was computed using Newcombe-Wilson method.
A Chi-squared test for independence was performed to examine the relationship between diabetic status and hemoglobin response. The relationship between these variables was not statistically significant, χ²(1, N=171) = 0.251, p = 0.617. These results suggest that the efficacy of efepoetin alfa is comparable between anemic CKD patients with and without diabetes.
For the group of patients receiving mPEG-epoetin beta, no statistically significant association was found between diabetic status and the hemoglobin response rate, χ²(1, N=169) = 0.510, p = 0.475. This result indicates that the effectiveness of mPEG-epoetin beta is comparable between the diabetic and non-diabetic subgroups.
Previously in the phase 3 clinical trial, efepoetin alfa established non-inferiority compared to mPEG-epoetin beta. In this subgroup analysis of the PP population, both long-acting ESAs administered once every two weeks demonstrated their ability in treating anemic CKD patients with diabetes mellitus and without diabetes mellitus. No statistically significant difference in hemoglobin response rates was observed between diabetic and non-diabetic patients within either treatment arm. These findings support that efepoetin alfa and mPEG-epoetin beta are an effective treatment option for managing anemia in CKD with diabetes.
