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Darbepoetin alfa

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https://www.readbyqxmd.com/read/29556960/comprehensive-physicochemical-and-biological-characterization-of-the-proposed-biosimilar-darbepoetin-alfa-lbde-and-its-originator-darbepoetin-alfa-nesp-%C3%A2
#1
Yeong Ran Jeong, Rae Ung Jeong, Jeong Hyun Son, Joon Cheol Kwon, Saem Jung, Mi A Song, Jin Ah Hwang, Gyun Min Lee
BACKGROUND: For regulatory approval, the comparability of a biosimilar product to an originator product should be ensured through thorough physicochemical and biological characterization. OBJECTIVE: To evaluate the biosimilarity between LBDE, the proposed biosimilar darbepoetin alfa, and NESP® , its originator, we performed a comprehensive physicochemical and biological characterization study. METHODS: Primary and higher-order protein structures were analyzed using Lys-C peptide mapping with liquid chromatography-mass spectrometry (LC-MS), disulfide bond identification, circular dichroism, and fluorescence spectroscopy...
March 19, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29545827/a-novel-outpatient-desensitization-protocol-for-recombinant-human-erythropoietin-allergy-in-a-pediatric-patient
#2
Jaime S Rosa, Van B Vuong, Orly Haskin, Anne Y Liu
Background: Recombinant human erythropoietin, such as epoetin alfa and darbepoetin alfa, is an important therapy for anemia due to chronic renal failure. Allergy to recombinant human erythropoietin and the need for desensitization are rare. Case presentation: We report here a novel epoetin alfa outpatient desensitization protocol in a girl who developed delayed cutaneous hypersensitivity to subcutaneous epoetin alfa and intravenous darbepoetin alfa. An initial attempt at traditional epoetin alfa desensitization failed, so we created a slower 17-day outpatient desensitization that succeeded and allowed treatment continuation...
2018: Allergy, Asthma, and Clinical Immunology
https://www.readbyqxmd.com/read/29523409/dahanca-10-effect-of-darbepoetin-alfa-and-radiotherapy-in-the-treatment-of-squamous-cell-carcinoma-of-the-head-and-neck-a-multicenter-open-label-randomized-phase-3-trial-by-the-danish-head-and-neck-cancer-group
#3
Jens Overgaard, Camilla Molich Hoff, Hanne Sand Hansen, Lena Specht, Marie Overgaard, Pernille Lassen, Elo Andersen, Jørgen Johansen, Lisbeth Juhler Andersen, Jan Folkvard Evensen, Jan Alsner, Cai Grau
PURPOSE: To evaluate if correction of low hemoglobin (Hb) levels by means of darbepoetin alfa improves the outcomes of radiotherapy in patients with squamous cell carcinoma of the head and neck (HNSCC). PATIENTS AND METHODS: Patients eligible for primary radiotherapy and who had Hb values below 14.0 g/dl were randomized to receive accelerated fractionated radiotherapy with or without darbepoetin alfa. Patients also received the hypoxic radiosensitizer nimorazole...
April 2018: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/29521269/the-effect-of-darbepoetin-alfa-on-renal-fibrosis-in-rats-with-acute-unilateral-ureteral-obstruction
#4
Ozgur Haki Yuksel, Caglar Yildirim, Ahmet Urkmez, Nurver Ozbay, Fatih Uruc, Aytac Sahin, Serkan Akan, Ayhan Verit
OBJECTIVES: The most important treatment strategy for obstructive nephropathy is to protect renal tissue from the deleterious effects of fibrosis. Therefore, we sought to investigate the renoprotective effects of darbepoetin alfa on unilateral ureteral obstructions. METHODS: We used 12 female and 12 male 3-monthold Wistar rats weighing between 250 and 350 g. The rats were divided equally into sham, darbepoetin and control groups. With the exception of the sham group, left unilateral obstructions were applied to all of the rats...
March 2018: Archivos Españoles de Urología
https://www.readbyqxmd.com/read/29429032/comparative-risk-benefit-profile-of-biosimilar-and-originator-erythropoiesis-stimulating-agents-esas-data-from-an-italian-observational-study-in-nephrology
#5
Domenico Motola, Alberto Vaccheri, Andrea Roncadori, Monia Donati, Giulia Bonaldo, Anna Covezzoli, Piera Polidori, Stefano Bianchi
PURPOSE: The aim of this multicenter prospective study was to evaluate efficacy and safety of biosimilar erythropoiesis-stimulating agents (ESAs) vs originator, based on data from clinical practice in patients with chronic kidney disease (CKD). METHODS: We collected data of the patients with diagnosis of CKD on conservative treatment from nine Italian structures. Patients were enrolled applying different exclusion criteria, and various individual parameters were registered at the beginning for descriptive analysis...
February 10, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29367268/hyporesponsiveness-to-darbepoetin-alfa-in-patients-with-heart-failure-and-anemia-in-the-red-hf-study-reduction-of-events-by-darbepoetin-alfa-in-heart-failure-clinical-and-prognostic-associations
#6
Peter van der Meer, Niels Grote Beverborg, Marc A Pfeffer, Kurt Olson, Inder S Anand, B Daan Westenbrink, John J V McMurray, Karl Swedberg, James B Young, Scott D Solomon, Dirk J van Veldhuisen
BACKGROUND: A poor response to erythropoiesis-stimulating agents such as darbepoetin alfa has been associated with adverse outcomes in patients with diabetes mellitus, chronic kidney disease, and anemia; whether this is also true in heart failure is unclear. METHODS AND RESULTS: We performed a post hoc analysis of the RED-HF trial (Reduction of Events by Darbepoetin Alfa in Heart Failure), in which 1008 patients with systolic heart failure and anemia (hemoglobin level, 9...
February 2018: Circulation. Heart Failure
https://www.readbyqxmd.com/read/29157782/comparative-assessment-of-the-effect-of-hyper-glycosylation-on-the-pattern-and-kinetics-of-degradation-of-darbepoetin-alfa-using-a-stability-indicating-orthogonal-testing-protocol
#7
Eman M Moenes, Medhat A Al-Ghobashy, Abeer A Mohamed, Maissa Y Salem
Darbepoetin alfa (DA); hyper-glycosylated Erythropoietin alfa (EPO) is an essential treatment of anemia in patients with chronic kidney failure and cancer. In this study, DA and EPO were subjected to physicochemical stress factors that might be encountered during production, transport and storage (pH, temperature, agitation, repeated freeze-thaw and oxidation). An orthogonal stability-indicating assay protocol comprised of SE-HPLC, RP-HPLC, ELISA and SDS-PAGE was developed and validated to investigate the effect of further glycosylation of DA on the pattern and kinetics of degradation...
January 1, 2018: Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
https://www.readbyqxmd.com/read/29097481/efficacy-and-long-term-safety-of-c-e-r-a-maintenance-in-pediatric-hemodialysis-patients-with-anemia-of-ckd
#8
Michel Fischbach, Elke Wühl, Sylvie C Meyer Reigner, Zoe Morgan, Franz Schaefer
BACKGROUND AND OBJECTIVES: The study was conducted to identify a conversion factor for switching from previous erythropoiesis-stimulating agents (ESAs) to continuous erythropoietin receptor activator-methoxy polyethylene glycol-epoetin beta (C.E.R.A.) and to document the efficacy and long-term safety of C.E.R.A. in pediatric patients with anemia of CKD undergoing hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this open-label, multicenter study, patients aged 6-17 years, with stable chronic anemia of CKD, undergoing hemodialysis received C...
January 6, 2018: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/28960777/prognostic-importance-of-emerging-cardiac-inflammatory-and-renal-biomarkers-in-chronic-heart-failure-patients-with-reduced-ejection-fraction-and-anaemia-red-hf-study
#9
Paul Welsh, Lei Kou, Changhong Yu, Inder Anand, Dirk J van Veldhuisen, Aldo P Maggioni, Akshay S Desai, Scott D Solomon, Marc A Pfeffer, Sunfa Cheng, Lars Gullestad, Pål Aukrust, Thor Ueland, Karl Swedberg, James B Young, Michael W Kattan, Naveed Sattar, John J V McMurray
AIMS: To test the prognostic value of emerging biomarkers in the Reduction of Events by Darbepoetin Alfa in Heart Failure (RED-HF) trial. METHODS AND RESULTS: Circulating cardiac [N-terminal pro-B-type natriuretic peptide (NT-proBNP), and high-sensitivity troponin T (hsTnT)], neurohumoral [mid-regional pro-adrenomedullin (MR-proADM) and copeptin], renal (cystatin C), and inflammatory [high-sensitivity C-reactive protein (hsCRP)] biomarkers were measured at randomization in 1853 participants with complete data...
February 2018: European Journal of Heart Failure
https://www.readbyqxmd.com/read/28875480/erratum-to-rationale-and-design-of-observational-clinical-research-in-chronic-kidney-disease-patients-with-renal-anemia-renal-prognosis-in-patients-with-hyporesponsive-anemia-to-erythropoiesis-stimulating-agents-darbepoetin-alfa-brighten-trial
#10
Hideki Kato, Masaomi Nangaku, Hideki Hirakata, Takashi Wada, Terumasa Hayashi, Hiroshi Sato, Yasushi Yamazaki, Takao Masaki, Tatsuo Kagimura, Hiroyasu Yamamoto, Hiroki Hase, Masahiro Kamouchi, Enyu Imai, Kyoichi Mizuno, Manabu Iwasaki, Tadao Akizawa, Yoshiharu Tsubakihara, Shoichi Maruyama, Ichiei Narita
No abstract text is available yet for this article.
February 2018: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28815341/de-novo-weekly-and-biweekly-darbepoetin-alfa-dosing-in-pediatric-patients-with-chronic-kidney-disease
#11
Bradley A Warady, John Barcia, Nadine Benador, Augustina Jankauskiene, Kurt Olson, Ludmila Podracka, Aleksey Shavkin, Poyyapakkam Srivaths, Cynthia J Wong, Jeffrey Petersen
BACKGROUND: Darbepoetin alfa is a commonly prescribed erythropoiesis-stimulating agent (ESA) for correcting anemia in pediatric chronic kidney disease (CKD) patients. However, little information exists on its use in ESA-naïve patients. This study evaluated the efficacy and safety of darbepoetin alfa in pediatric patients initiating ESA therapy. METHODS: One-hundred sixteen pediatric ESA-naïve subjects (aged 1-18 years) with CKD stages 3-5D and hemoglobin (Hb) <10 g/dl from 43 centers in the US, Europe, and Mexico were randomized by age (three groups) and dialysis status (yes vs...
January 2018: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28814194/real-world-utilization-of-darbepoetin-alfa-in-cancer-chemotherapy-patients
#12
Xiaoyun Lucy Pan, Beth L Nordstrom, Sharon MacLachlan, Junji Lin, Hairong Xu, Anjali Sharma, David Chandler, Xiaoyan Shawn Li
Objectives To provide an understanding of darbepoetin alfa dose patterns in cancer patients undergoing myelosuppressive chemotherapy starting from 2011. Study design This is a retrospective cohort study using a proprietary outpatient oncology database. Methods Metastatic, solid tumor cancer patients receiving concomitant myelosuppressive chemotherapy and darbepoetin alfa with an associated hemoglobin <10 g/dL during 2011-2015 were identified. The analysis was restricted to the first continuous exposure to chemotherapy agents (maximum allowable gap of 90 days between consecutive exposures) with darbepoetin alfa for each eligible patient...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28782299/continuous-erythropoiesis-receptor-activator-cera-for-the-anaemia-of-chronic-kidney-disease
#13
REVIEW
Valeria M Saglimbene, Suetonia C Palmer, Marinella Ruospo, Patrizia Natale, Jonathan C Craig, Giovanni Fm Strippoli
BACKGROUND: Continuous erythropoiesis receptor activator (CERA) is a newer, longer acting ESA which might be preferred to other ESAs (epoetin or darbepoetin) based on its lower frequency of administration. Different dosing requirements and molecular characteristics of CERA compared with other ESAs may lead to different health outcomes (mortality, cardiovascular events, quality of life) in people with anaemia and chronic kidney disease (CKD). OBJECTIVES: To assess benefits and harms of CERA compared with other epoetins (darbepoetin alfa and epoetin alfa or beta) or placebo/no treatment or CERA with differing strategy of administration for anaemia in individuals with CKD...
August 7, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28717516/costs-associated-with-intravenous-darbepoetin-versus-epoetin-therapy-in-hemodialysis-patients-a-randomized-controlled-trial
#14
Andrea L Woodland, Sean W Murphy, Bryan M Curtis, Brendan J Barrett
BACKGROUND: Anemia of chronic kidney disease is associated with adverse outcomes and a reduced quality of life. Erythropoiesis-stimulating agents (ESAs) have improved anemia management, and 2 agents are available in Canada, epoetin alfa (EPO) and darbepoetin alfa (DA). EPO and DA are considered equally effective in achieving target hemoglobin (Hb), but it is not clear whether there is a cost difference. There have been few head-to-head comparisons; most published studies are observational switch studies...
2017: Canadian Journal of Kidney Health and Disease
https://www.readbyqxmd.com/read/28660446/rationale-and-design-of-observational-clinical-research-in-chronic-kidney-disease-patients-with-renal-anemia-renal-prognosis-in-patients-with-hyporesponsive-anemia-to-erythropoiesis-stimulating-agents-darbepoetin-alfa-brighten-trial
#15
Hideki Kato, Masaomi Nangaku, Hideki Hirakata, Takashi Wada, Terumasa Hayashi, Hiroshi Sato, Yasushi Yamazaki, Takao Masaki, Tatsuo Kagimura, Hiroyasu Yamamoto, Hiroki Hase, Masahiro Kamouchi, Enyu Imai, Kyoichi Mizuno, Manabu Iwasaki, Tadao Akizawa, Yoshiharu Tsubakihara, Shoichi Maruyama, Ichiei Narita
BACKGROUND: Renal anemia is an important complication in non-dialysis chronic kidney disease (CKD) patients as well as in dialysis patients. Although recombinant human erythropoietin has dramatically improved prognosis and quality of life in these patients, there have been issues among non-dialysis CKD patients who exhibit hyporesponsiveness to erythropoiesis-stimulating agent (ESA). The causes and definition of ESA hyporesponsiveness, as well as the incidence of renal and cardiovascular disease (CVD) events in such patients, are yet to be clarified...
February 2018: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28626220/a-phase-3-randomized-placebo-controlled-trial-of-darbepoetin-alfa-in-patients-with-anemia-and-lower-risk-myelodysplastic-syndromes
#16
RANDOMIZED CONTROLLED TRIAL
U Platzbecker, A Symeonidis, E N Oliva, J S Goede, M Delforge, J Mayer, B Slama, S Badre, E Gasal, B Mehta, J Franklin
The use of darbepoetin alfa to treat anemia in patients with lower-risk myelodysplastic syndromes (MDS) was evaluated in a phase 3 trial. Eligible patients had low/intermediate-1 risk MDS, hemoglobin ⩽10 g/dl, low transfusion burden and serum erythropoietin (EPO) ⩽500 mU/ml. Patients were randomized 2:1 to receive 24 weeks of subcutaneous darbepoetin alfa 500 μg or placebo every 3 weeks (Q3W), followed by 48 weeks of open-label darbepoetin alfa. A total of 147 patients were randomized, with median hemoglobin of 9...
September 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/28540882/carnitine-reduced-erythropoietin-dose-required-and-improved-cardiac-function-of-patients-on-maintenance-hemodialysis
#17
Yosuke Aoki, Takako Yamamoto
Intravenous administration of 2 g carnitine in every hemodialysis (3 times/week), for 8-10 months, reduced doses of darbepoetin alfa required to maintain adequate hemoglobin levels (10-11 g/dL) into 10% of the initial doses. There was also a significant increase in plasma transferrin saturation, increase in left ventricular ejection fraction, and decrease in plasma brain natriuretic peptides.
May 2017: Saudi Journal of Kidney Diseases and Transplantation
https://www.readbyqxmd.com/read/28391437/oral-sucrosomial-iron-versus-intravenous-iron-in-anemic-cancer-patients-without-iron-deficiency-receiving-darbepoetin-alfa-a-pilot-study
#18
Antonino Mafodda, D Giuffrida, A Prestifilippo, D Azzarello, R Giannicola, M Mare, R Maisano
PURPOSE: Erythropoiesis-stimulating agents (ESAs) are often used in treatment of patients with chemotherapy-induced anemia. Many studies have demonstrated an improved hemoglobin (Hb) response when ESA is combined with intravenous iron supplementation and a higher effectiveness of intravenous iron over traditional oral iron formulations. A new formulation of oral sucrosomial iron featuring an increased bioavailability compared to traditional oral formulations has recently become available and could provide a valid alternative to those by intravenous (IV) route...
September 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28256075/the-use-of-darbepoetin-to-stimulate-erythropoiesis-in-the-treatment-of-anemia-of-chronic-kidney-disease-in-dogs
#19
E H Fiocchi, L D Cowgill, D C Brown, J E Markovich, S Tucker, M A Labato, M B Callan
BACKGROUND: Darbepoetin alfa (darbepoetin) is an erythropoiesis-stimulating agent used for the treatment of anemia secondary to chronic kidney disease (CKD) in dogs, but reports describing response are lacking. HYPOTHESIS/OBJECTIVES: To evaluate the effectiveness of darbepoetin in dogs with anemia secondary to CKD, dosing protocols, and adverse events. ANIMALS: Thirty-three client-owned dogs with naturally occurring CKD, including 26 with comorbidities...
March 2017: Journal of Veterinary Internal Medicine
https://www.readbyqxmd.com/read/28067195/combined-erythropoietin-and-iron-therapy-for-anaemic-patients-undergoing-transcatheter-aortic-valve-implantation-the-epicure-randomised-clinical-trial
#20
RANDOMIZED CONTROLLED TRIAL
Marina Urena, Maria Del Trigo, Omar Abdul-Jawad Altisent, Francisco Campelo-Prada, Ander Regueiro, Robert DeLarochellière, Daniel Doyle, Siamak Mohammadi, Jean-Michel Paradis, François Dagenais, Eric Dumont, Rishi Puri, Vincent Laroche, Josep Rodés-Cabau
AIMS: The aim of this study was to evaluate, in anaemic patients, the efficacy of erythropoietin (EPO) in reducing red cell (RC) transfusion rates post TAVI. METHODS AND RESULTS: This was a randomised double-blind trial. Patients with severe symptomatic aortic stenosis and concomitant anaemia with an indication for TAVI were randomised (1:1) to receive two weight-based doses of EPO (darbepoetin alfa)+iron or placebo at days 10 (±4 days) and 1 (±1 day) pre TAVI...
May 15, 2017: EuroIntervention
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