The first russian darbepoetin alfa bioanalogue: results of a double-blind, randomized clinical study of efficacy and safety for patients with nephrogenic anemia on programmed hemodialysis


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Abstract

Objective. to prove the equivalent efficacy and safety of Darbestim (ZAO BIOCAD, Russia) and Aranesp (Amgen Europe B.V., The Netherlands) when used to maintain target hemoglobin levels in patients with end-stage chronic kidney disease (CKD) on hemodialysis. Material and methods. a double-blind, randomized, parallel group comparative clinical study of the efficacy and safety of Darbestim and Aranesp included 196 patients with anemia against the background of end-stage CKD (CKD 5D) who were on program hemodialysis and regularly received recombinant human erythropoietin (rhEPO) preparations. Participants were randomly assigned to two groups of therapy: patients in the first group (n=98) received Darbestim, patients in the second group (n=98) - Aranesp. The main stage of the study lasted from the 1st to the 24th week of therapy inclusive; after it was completed, an analysis of the efficacy, safety and immuno-genicity of the drugs was performed; the results of analysis are presented in this article. After the 24th week, all patients continued to receive therapy for up to one year in order to further assess the safety and efficacy of long-term therapy. The primary endpoint of effectiveness was a change in hemoglobin level. Results. Efficacy analysis was conducted in the population of patients who completed 24 weeks of therapy (per protocol population (n=176): in group 1 (Darbestim) 86 patients were included in the analysis, in group 2 (Aranesp) - 90. Average value of change in hemoglobin level in the group I was 4.7±ii.0 g/L, in the group 2 -4.6±9.0 g/L (P=0.9717). The 95% confidence interval (Cl) for the between-group difference of arithmetic mean values of the indicator "change in hemoglobin level during the evaluation period compared with the initial level" was [-3.04; 2.93]; the DI within the pre-defined boundaries of [-5.00; 5.00] indicate the equivalent efficacy of the two drugs being compared. Safety analysis between the test drug and the reference drug revealed no differences in both the spectrum and the frequency of the registered AEs and SAEs. Conclusion. In the framework of this study, the equivalent efficacy and safety of Darbestim (ZAO BIOCAD, Russia) and Aranesp (Amgen Europe B.V., The Netherlands) were proved.

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About the authors

V. Yu Shilo

FSBEI HE "A.i. Yedokimov Moscow State University of Medicine and Dentistry” of the Ministry of Health of the Russian Federation; ООО "B. Braun Avitum Russland Clinics"

Email: nephrolog@gmail.com
PhD in Medical Science, Associate Professor at the Department of Nephrology; medical director

V. P Babich

ООО Medical Center "NEPHROS"

G. V Vasilieva

ООО "St. Petersburg Dialysis Center"

K. A Vishnevsky

SPbSBHCI "City Hospital № 15"

T. A Gomova

SHCI TR "Tula Regional Clinical Hospital"

V. P Doru-Tovt

SI "St. Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine"

M. V Dudarev

ООО "Alliance Biomedical - Ural Group"

L. F Yeremeeva

ООО "Fresenius Medical Care Kuban"; Krasnodar

A. V Zuev

SBHCI RK "Republican Hospital.n.a. V.A. Baranov"

L. I Kotova

BHCI OR "Regional Clinical Hospital"

I. L Novoseltsev

ООО "Dialysis Center"

G. V Rodoman

SBHCI "City Clinical Hospital № 24 of the Moscow Healthcare Department"

V. Yu Ryasnyansky

FSBEI he "North-Western State Medical University n.a. I.I. Mechnikov" of the Ministry of Health of the Russian Federation

A. B Sabodash

ООО "В. Braun Avitum Russland Clinics"

A. V Solovyova

FSBEI he "Tver State Medical University" of the Ministry of Health of the Russian Federation

O. M Solovyova

SPbSBHCI "City Hospital of the Holy Reverend Martyr Elizabeth"

V. N Suchkov

SPbSBHCI "Mariinsky City Hospital"

A. G Strokov

FSBI "Academician V.I. Shumakov Federal Scientific Center of Transplantology and Artificial Organs" of the Ministry of Health of the Russian Federation

G. Yu Timokhovskaya

SPbSBHCI "City Clinical Hospital № 31"

V. M Chistyakov

ООО "New Clinic"

L. A Shpagina

SBHCI NR "City Clinical Hospital № 2"; Novosibirsk

L. A Fedotova

ООО "Nephroline-Novosibirsk"

N. G Khadikova

SPbSBHCI "Nikolaev Hospital"

E. V Khazova

FSBEI HE "Kazan State Medical University Ministry" of the Ministry of Health of the Russian Federation

M. A Morozova

ZAO "BIOCAD"

E. A Dokukina

ZAO "BIOCAD"

Yu. N Lin’kov

ZAO "BIOCAD"

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