Alexey Mikhailovich Omelchenko

St. Petersburg State Health Care Foundation "Mariinsky City Hospital"

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Anastasia Sabodash

First Pavlov State Medical University of St. Petersburg

N. N. Kulaeva

Northwestern State University

A. Sh. Rumyantsev

First Pavlov State Medical University of St. Petersburg

Alexander Zemchenkov

St. Petersburg State Health Care Foundation "Mariinsky City Hospital"

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Роман Герасимчук

North-Western State Medical University named after I.I. Mechnikov

Alexey Pavlovich Tutin

Konstantin Vishnevskii

North-Western State Medical University named after I.I. Mechnikov

Tatyana Pavlovna Mironova

Samara State Medical University

Bolong Miao

Vetchinnikova On

Regional Clinical Research

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North-Western State Medical University named after I.I. Mechnikov

Ministry of Health of the Russian Federation

First Pavlov State Medical University of St. Petersburg

St. Petersburg State Health Care Foundation "Mariinsky City Hospital"

St. Petersburg State Medical Academy "City Hospital No. 26"

Samara State Medical University

Gabrichevsky Institute of Epidemiology and Microbiology

Volgograd Regional Clinical Oncology Center

City Hospital No. 40

Regional Clinical Research

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Medicine (2022)

Bolong Miao Алина Исачкина Evgeny Viktorovich Shutov Alexander Alekseevich Selyutin Lyudmila Vladimirovna Kvitkova

Background: EPREX ® /ERYPO ® /PROCRIT ® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as per the recommendation provided by European Medicines Agency. EPIAO ® is a biosimilar formulation of EPREX ® , and making it a 1:1 dose conversion from EPREX ® according to recommendation of European Medicines Agency. This study evaluated the clinical efficacy and safety of EPIAO ® in subjects with end-stage renal disease receiving hemodialysis after intravenous administration. Methods: This study was a multicenter, prospective, randomized, double-blind, parallel-group, 2-cohort, maintenance phase, therapeutic equivalence study to evaluate a 1:1 dose conversion from EPREX ® to EPIAO ® in terms of clinical efficacy and safety that was conducted at 20 sites in 2 countries in patients with end-stage renal disease on hemodialysis. Eligible subjects were treated with EPREX ® (reference product of epoetin) for a period of at least 3 months before the treatment period, and then were randomly assigned to the group of EPREX ® or EPIAO ® . Primary endpoints were mean absolute change in hemoglobin level and mean absolute change in weekly epoetin dosage from baseline to 6 months after treatment with EPIAO ® /EPREX ® in parallel groups. Results: A total of 200 people received the random intervention and were included in the safety set. After 6, 9, and 12 months of treatment with EPIAO ® or EPREX ® , there were no significant differences in the hemoglobin levels of the 2 groups compared with baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ±0.5 g/dL. There were no significant differences in the epoetin dosage of the 2 groups compared with the baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ± 45 IU/kg. There were no significant differences in the incidence of adverse events between the EPIAO ® and EPREX ® groups. Most adverse events were mild to moderate and were reverted/resolved. Conclusion: EPIAO ® demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis.

Epoetin alfa

10.1097/md.0000000000031426

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Citations (3)

DIALYSIS START TIMING: DEVELOPMENT AND VALIDATION OF START SCORING SCALE

Russian Journal of Transplantology and Artificial Organs (2018)

Alexander Zemchenkov Роман Герасимчук Anastasia Sabodash Konstantin Vishnevskii G. A. Zemchenkov

Aim. The optimal time for initiating of chronic dialysis remains unknown. The scale for mortality risk assessment could help in decision-making concerning dialysis start timing. Methods. We randomly divided 1856 patients started dialysis in 2009–2016 into developmental and validation group (1:1) to create and validate scoring system «START» predicting mortality risk at dialysis initiation in order to ﬁ nd unmodiﬁ able and modiﬁ able factors which could help in the decision-making of dialysis start. In the series of univariate regression models in the developmental set, we evaluated the mortality risk linked with available parameters: age, eGFR, serum phosphate, total calcium, hemoglobin, Charlson comorbidity index, diabetes status, urgency of start (turned to be signiﬁ cant) and gender, serum sodium, potassium, blood pressure (without impact on survival). Similar hazard ratios were converted to score points. Results. The START score was highly predictive of death: C-statistic was 0.82 (95% CI 0.79–0.85) for the developmental dataset and 0.79 (95% CI 0.74–0.84) for validation dataset (both p < 0.001). On applying the cutoff between 7–8 points in the developmental dataset, the risk score was highly sensitive 81.1% and speciﬁ c 67.9%; for validation dataset, the sensitivity was 78.9%, speciﬁ city 67.9%. We conﬁ rmed the similarity in survival prediction in the validation set to developmental set in low, medium and high START score groups. The difference in survival between three levels of START-score in validation set remained similar to that of developmental set: Wilcoxon = 8.78 (p = 0.02) vs 15.31 (p < 0.001) comparing low–medium levels and 25.18 (p < 0.001) vs 39.21 (p < 0.001) comparing medium–high levels. Conclusion. Developed START score system including modiﬁ able factors showed good mortality prediction and could be used in dialysis start decision-making.

Univariate

Statistic

10.15825/1995-1191-2018-2-47-60

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Citations (4)

Survival analysis for older and frail patients starting dialysis and external validation of the REIN scale

Nephrology and Dialysis (2018)

Alexander Zemchenkov Anastasia Sabodash Alexey Mikhailovich Omelchenko N. N. Kulaeva Daria Sadovskaya

10.28996/2618-9801-2018-4-357-365

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