Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients?
Casadevall N, Dobronravov V, Eckardt KU, Ertürk S, Martynyuk L, Schmitt S, Schaffar G, Rudy A, Krendyukov A, Ode M (2017)
Publication Type: Journal article
Publication year: 2017
Journal
DOI: 10.5414/CN109159
Abstract
To assess the safety and immunogenicity of subcutaneous (SC) HX575 (epoetin-?) in dialysis- and nondialysis-dependent adult patients with chronic kidney disease (CKD).Open-label, single-arm, multicenter study in patients (n = 416) from Germany, Italy, Poland, Romania, Russia, Turkey, and Ukraine.Mean (standard deviation (SD)) age was 52.3 (15.8) years, all patients were Caucasian, and similar proportions were male/female. 250 patients (60.1%) were erythropoiesis-stimulating agent (ESA)-naïve, and 166 (39.9%) were receiving ESA maintenance therapy at study start; mean (SD) on-study treatment duration with HX575 was 43.4 (15.8) weeks and 45.3 (13.7) weeks, respectively. Binding antierythropoietin (EPO) antibodies were detected by radioimmunoprecipitation (RIP) assay in 7 patients (1.7%; incidence 0.019); 5 of these were ESA-naïve at study entry. No patient developed neutralizing antibodies as determined in a cell-based epoetin neutralizing assay. Of the 7 patients with a positive binding anti-EPO RIP assay, 4 tested negative at later time points while continuing HX575 treatment. Three patients had low titers of anti-EPO antibodies at the last study assessment. There were no clinical signs of immunogenicity or hypersensitivity.SC HX575 was effective for correcting and maintaining correction of anemia, and the mean weekly dose remained stable over time.?.
Authors with CRIS profile
Involved external institutions
Hexal AG
Germany (DE)
Ternopil State Medical University
Ukraine (UA)
Ankara University / Ankara Üniversitesi
Turkey (TR)
First Pavlov State Medical University of St. Petersburg
Russian Federation (RU)
Hôpital Saint-Antoine
France (FR)
Germany (DE)
Ternopil State Medical University
Ukraine (UA)
Ankara University / Ankara Üniversitesi
Turkey (TR)
First Pavlov State Medical University of St. Petersburg
Russian Federation (RU)
Hôpital Saint-Antoine
France (FR)
How to cite
APA:
Casadevall, N., Dobronravov, V., Eckardt, K.-U., Ertürk, S., Martynyuk, L., Schmitt, S.,... Ode, M. (2017). Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients? Clinical Nephrology. https://doi.org/10.5414/CN109159
MLA:
Casadevall, Nicole, et al. "Evaluation of the safety and immunogenicity of subcutaneous HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in predialysis and dialysis patients?" Clinical Nephrology (2017).
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