Browsing by Author "Andric, Branislav (26433154600)"

Authors want to correct the list of authors by expanding the number of coauthors and by including all contributors in the Vascular Access Study Group. Vascular Access Study Group (in alphabetic order): Andric Branislav, Antic Miodrag, Aracki Snezana, Arsenovic Aleksandra, Berto Sabo Anika, Bogdanovic Jasmina, Cekovic Biljana, Cuckovic Cedomir, Cukic Zoran, Cveticanin Anica, Djordjevic Verica, Dudic Svetlana, Gajic Snezana, Gojakovic Biljana, Golubovic Predrag, Gucic Ljubinka, Hadzibulic Edvin, Hadzifejzovic Mersada, Hamzagic Nedim, Haviza-Lilic Branimir, Ilic Mira, Ilic Nasta, Jelacic Rosa, Kostic Mirjana, Kovacevic Miodrag, Lazarevic Tatjana, Markovic Rodoljub, Micunovic Vesna, Milenkovic Olgica, Milenkovic Radomir, Milenkovic Srboljub, Milicevic Biserka, Milicevic Olivera, Nikolic Zora, Obrenovic Slavica, Orescanin Mira, Pavlovic Stevan, Pesic Snezana, Petkovic Dobrila, Pilipovic Dragana, Prokopovic Miomir, Radovanovic Zoran, Rakic Nenad, Rangelov Vanja, Sefer Kornelija, Sibalic Simin Marija, Stefanovic Nikola, Stojanovic Dragoslav, Stojanovic Stanojevic Marina, Tirmenstajn Jankovic Biserka, Vasic Jovanovic Vesna, Vasilic Kokotovic Olivera, Vojinovic Goran, Vuckovic Dragana, Vukelic Vesna, Vukic Jasmina, Zagorac Nikola, Zec Nenad. © 2017, Springer Science+Business Media Dordrecht.

Background: Roxadustat is an orally active hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of chronic kidney disease (CKD) anemia. Methods: This Phase 3, multicenter, randomized, double-blind, placebo-controlled study examined patients with Stages 3-5 CKD, not on dialysis (NCT01887600). Patients were randomized (2:1) to oral roxadustat or placebo three times weekly for 52-104 weeks. This study examined two primary efficacy endpoints: European Union (European Medicines Agency)-hemoglobin (Hb) response, defined as Hb ≥11.0 g/dL that increased from baseline (BL) by ≥1.0 g/dL in patients with Hb >8.0 g/dL or ≥2.0 g/dL in patients with BL Hb ≤8.0 g/dL, without rescue therapy, during the first 24 weeks of treatment; US Food and Drug Administration-change in Hb from BL to the average Hb level during Weeks 28-52, regardless of rescue therapy. Secondary efficacy endpoints and safety were examined. Results: A total of 594 patients were analyzed (roxadustat: 391; placebo: 203). Superiority of roxadustat versus placebo was demonstrated for both primary efficacy endpoints: Hb response [odds ratio = 34.74, 95% confidence interval (CI) 20.48-58.93] and change in Hb from BL [roxadustat-placebo: +1.692 (95% CI 1.52-1.86); both P < 0.001]. Superiority of roxadustat was demonstrated for low-density lipoprotein cholesterol change from BL, and time to first use of rescue medication (both P < 0.001). The incidences of treatment-emergent adverse events were comparable between groups (roxadustat: 87.7%, placebo: 86.7%). Conclusions: Roxadustat demonstrated superior efficacy versus placebo in terms of both Hb response rate and change in Hb from BL. The safety profiles of roxadustat and placebo were comparable. © 2021 The Author(s) 2021. Published by Oxford University Press on behalf of ERA-EDTA.