Impaired renal or hepatic function had no clinically relevant effect on the pharmacokinetic profile of vadadustat [5, 15] and there were no clinically relevant changes in exposure to vadadustat when the drug was administered with food [16]. Vadadustat is in global Phase 3 development for the treatment of anemia due to CKD and is not approved by the U.S. Food and Drug Administration (FDA) or … © 2021 Springer Nature Switzerland AG. 90.9% of patients who had received vadadustat for 16 weeks had a haemoglobin level within the target range of 10–12 g/dL. Article The mean haemoglobin level between weeks 40 and 52 was 10.51 g/dL in the vadadustat group versus 10.55 g/dL in darbepoetin alfa recipients (LSM difference between groups − 0.07 g/dL; 95% CI − 0.34 to 0.19) [6]. In INNO2VATE-correction/conversion, incident dialysis patients with end stage renal disease and limited exposure to recombinant ESAs were randomized to treatment with vadadustat (n = 181) or darbepoetin alfa (n = 188). 20 Dec 2016. https://akebia.com/. Coadministration with vadadustat increased the Cmax and AUC∞ of the BCRP substrates rosuvastatin, simvastatin, atorvastatin and salazosulfapyridine and the OAT3 substrate furosemide [5], but did not affect the exposure of the OATP1B1 substrate pravastatin or the OAT1 substrate adefovir [13]. Those occurring in < 1% of patients included sleep disorders, somnolence, retinal haemorrhage, vertigo, palpitations, polycythaemia, abdominal discomfort, vomiting, loose stools, gastritis, gastroenteritis, stomatitis, rash, pruritus, eczema, erythema, alopecia, cold sweats, frequent urination, increased blood creatinine levels, malaise, chest discomfort, nipple pain and peripheral oedema [5]. Within Japan, Vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and … LSM change in haemoglobin levels from the pretreatment level to week 6 were − 0.28, 0.08, 0.41 g/dL in the vadadustat 150, 300, and 600 mg/day groups compared with − 1.48 g/dL in the placebo group (all p < 0.001 vs. placebo). Clinical trial of vadadustat in patients with anemia secondary to stage 3 or 4 chronic kidney disease. Haase VH, Chertow GM, Block GA, et al. Corporate News, FDA, Management Comments. According to the Japanese prescribing information, adverse events occurring in ≥ 1% but < 5% of patients treated with vadadustat in Japanese trials were hypertension, diarrhoea and nausea [5]. While total iron binding capacity significantly increased and mean absolute ferritin significantly decreased after 16 weeks of vadadustat treatment across all groups, changes in transferrin saturation and hepcidin (apart from in the vadadustat 150 mg/day arm) were not significant [19]. Sanghani NS, Haase VH. Coadministration of vadadustat with the proton pump inhibitor rabeprazole was not associated with clinically relevant changes in vadadustat exposure [14]. Akebia Therapeutics (AKBA) Announces Approval of Vadadustat in Japan for Treatment of Anemia Due to CKD. Employee Login . 4 Jan 2016. https://akebia.com/. 2019;34(1):90–9. Drugs 80, 1365–1371 (2020). Akebia Therapeutics Inc. Akebia closes $41 million Series C [media release]. A further phase III study (NCT04313153) is evaluating the efficacy and safety of vadadustat once daily and three times weekly for the maintenance treatment of anaemia in haemodialysis patients converting from ESAs. Vadadustat is in global Phase 3 development for the treatment of anemia due to CKD and is not approved by the U.S. Food and Drug Administration (FDA… No statistically significant mean change in haemoglobin levels from the pre-baseline average to mid-trial (primary endpoint) was observed in any of the three groups [22]. In the per-protocol population, 54.9% of patients on vadadustat and 10.3% of patients on placebo achieved or maintained either a mean haemoglobin level of ≥ 11.0 g/dL or a mean increase in haemoglobin of ≥ 1.2 g/dL over the predose average during the last 2 weeks of treatment (primary endpoint). Mitsubishi Tanabe Pharma Corporation. Nos partenaires et nous-mêmes stockerons et/ou utiliserons des informations concernant votre appareil, par l’intermédiaire de cookies et de technologies similaires, afin d’afficher des annonces et des contenus personnalisés, de mesurer les audiences et les contenus, d’obtenir des informations sur les audiences et à des fins de développement de produit. 2020. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/400315_39990D3F1020_1_01. Vadadustat was noninferior to darbepoetin alfa in controlling haemoglobin levels in Japanese patients with CKD not dependent on dialysis who were either switched from other erythropoiesis stimulating agents (ESAs) [conversion] or had not received ESAs (correction) in an open label phase III study (NCT03329196) [17]. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond. A. Markham is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. Pour autoriser Verizon Media et nos partenaires à traiter vos données personnelles, sélectionnez 'J'accepte' ou 'Gérer les paramètres' pour obtenir plus d’informations et pour gérer vos choix. Zuk A, Si Z, Loi S, et al. Martin ER, Smith MT, Maroni BJ, et al. Vadadustat (VAFSEO tablets): Japanese prescribing information. The least square mean (LSM) average haemoglobin level at weeks 20 and 24 (primary endpoint) was 11.66 g/dL (95% CI 11.49–11.84 g/dL) in the vadadustat group compared to 11.93 g/dL (95% CI 11.76–12.10 g/dL) in darbepoetin alfa recipients (LSM difference between groups − 0.26 g/dL (95% CI − 0.50 to − 0.02). Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for treatment of anemia of chronic kidney disease: two randomized phase 2 trials in Japanese patients. 328]. PubMed Central J Am Soc Nephrol. 2019;30:8. 2019;30:212. After 16 weeks of treatment, changes in mean absolute haemoglobin from pretreatment levels in the respective vadadustat groups were 1.40, 2.44 and 1.64 g/dL, while that in patients who switched from placebo to vadadustat was 1.87 g/dL. Informations sur votre appareil et sur votre connexion Internet, y compris votre adresse IP, Navigation et recherche lors de l’utilisation des sites Web et applications Verizon Media.
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