keyword
https://read.qxmd.com/read/38412265/daprodustat-jesduvroq-for-anemia-of-chronic-kidney-disease
#1
JOURNAL ARTICLE
(no author information available yet)
No abstract text is available yet for this article.
February 19, 2024: Medical Letter on Drugs and Therapeutics
https://read.qxmd.com/read/33953543/comparison-of-pharmacokinetic-pharmacodynamic-and-tolerability-profiles-of-ckd-11101-darbepoetin-alfa-nesp-%C3%A2-biosimilar-to-those-of-nesp-%C3%A2-after-a-single-subcutaneous-or-intravenous-administration-to-healthy-subjects
#2
JOURNAL ARTICLE
Inseung Jeon, Jaeseong Oh, Yu-Kyung Kwon, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu, SeungHwan Lee
Introduction: Darbepoetin alfa (NESP® and ARANESP® ) has a sustained erythropoietic activity with a longer half-life than conventional recombinant human erythropoietin. CKD-11101 is under clinical development as a biosimilar of darbepoetin alfa. The purpose of this study was to compare the pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles of CKD-11101 with those of reference drug in healthy subjects. Methods: This study was performed in two parts for healthy subjects...
2021: Drug Design, Development and Therapy
https://read.qxmd.com/read/33844381/conversion-from-aranesp%C3%A2-to-nesp%C3%A2-in-dialysis-patients-exploration-of-dosing-strategies-and-the-feasibility-of-extending-the-dosing-interval
#3
JOURNAL ARTICLE
Maggie M Y Mok, Lorraine P Y Kwan, Gary C W Chan, Maggie K M Ma, Angela Y M Wang, Desmond Y H Yap, Cindy B Y Choy, Sydney C W Tang, Tak Mao Chan
AIM: Darbepoetin alpha is available as Aranesp® and NESP®, which differ in the inactive component and maximum dose-strength of prefilled syringes. We conducted an observational cohort study to investigate optimal conversion strategies and the feasibility of extending dosing intervals with higher-dose preparations in dialysis patients converting from Aranesp® to NESP®. METHODS: Adult dialysis patients on Aranesp® with stable haemoglobin of 9-12 g/dL were converted to NESP® at the same monthly total dose according to one of three conversion regimens...
September 2021: Nephrology
https://read.qxmd.com/read/31838284/glycan-analysis-of-erythropoiesis-stimulating-agents
#4
JOURNAL ARTICLE
Ben Cowper, Martin Lavén, Birgit Hakkarainen, Ezra Mulugeta
Erythropoiesis stimulating agents (ESAs) are a group of therapeutic glycoproteins used to treat anaemia caused by chronic kidney disease or chemotherapy. A variety of ESA products are available in the European Union, including innovator, biosimilar and second-generation medicines. Glycosylation is a critical quality attribute of ESA products, as it has a crucial influence upon in vivo biological activity. In this study, a combination of chromatography and mass spectrometry analysis has been used to characterise and compare the glycosylation profiles of five ESA products; Eprex® (epoetin alfa), NeoRecormon® (epoetin beta), Binocrit® (epoetin alfa biosimilar), Silapo (epoetin alfa biosimilar) and Aranesp® (darbepoetin alfa)...
February 20, 2020: Journal of Pharmaceutical and Biomedical Analysis
https://read.qxmd.com/read/30672083/metformin-use-and-cardiovascular-events-in-patients-with-type-2-diabetes-and-chronic-kidney-disease
#5
RANDOMIZED CONTROLLED TRIAL
David M Charytan, Scott D Solomon, Peter Ivanovich, Giuseppe Remuzzi, Mark E Cooper, Janet B McGill, Hans-Henrik Parving, Patrick Parfrey, Ajay K Singh, Emmanuel A Burdmann, Andrew S Levey, Kai-Uwe Eckardt, John J V McMurray, Larry A Weinrauch, Jiankang Liu, Brian Claggett, Eldrin F Lewis, Marc A Pfeffer
AIMS: Metformin could have benefits on cardiovascular disease and kidney disease progression but is often withheld from individuals with diabetes and chronic kidney disease (CKD) because of a concern that it may increase the risk of lactic acidosis. MATERIALS AND METHODS: All-cause mortality, cardiovascular death, cardiovascular events (death, hospitalization for heart failure, myocardial infarction, stroke or myocardial ischemia), end stage renal disease (ESRD) and the kidney disease composite (ESRD or death) were compared in metformin users and non-users with diabetes and CKD enrolled in the Trial to Reduce Cardiovascular Events with Aranesp (darbepoeitin-alfa) Therapy (TREAT) (NCT00093015)...
May 2019: Diabetes, Obesity & Metabolism
https://read.qxmd.com/read/30578152/treatment-of-anemia-with-darbepoetin-prior-to-dialysis-initiation-and-clinical-outcomes-analyses-from-the-trial-to-reduce-cardiovascular-events-with-aranesp-therapy-treat
#6
RANDOMIZED CONTROLLED TRIAL
Finnian R Mc Causland, Brian Claggett, Emmanuel A Burdmann, Glenn M Chertow, Mark E Cooper, Kai-Uwe Eckardt, Peter Ivanovich, Andrew S Levey, Eldrin F Lewis, Janet B McGill, John J V McMurray, Patrick Parfrey, Hans-Henrik Parving, Giuseppe Remuzzi, Ajay K Singh, Scott D Solomon, Robert D Toto, Marc A Pfeffer
RATIONALE & OBJECTIVE: Evidence from clinical trials to guide patient preparation for maintenance dialysis therapy is limited. Although anemia is associated with mortality and cardiovascular (CV) disease in individuals initiating maintenance dialysis therapy, it is not known if treatment of anemia before dialysis therapy initiation with erythropoiesis-stimulating agents alters outcomes. STUDY DESIGN: Post hoc analysis of a randomized controlled trial. SETTING & PARTICIPANTS: Participants with type 2 diabetes and chronic kidney disease who progressed to dialysis therapy (n=590) in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)...
March 2019: American Journal of Kidney Diseases
https://read.qxmd.com/read/29241199/change-in-hemoglobin-trajectory-and-darbepoetin-dose-approaching-end-stage-renal-disease-data-from-the-trial-to-reduce-cardiovascular-events-with-aranesp-therapy-trial
#7
RANDOMIZED CONTROLLED TRIAL
Finnian R Mc Causland, Brian Claggett, Marc A Pfeffer, Emmanuel A Burdmann, Kai-Uwe Eckardt, Andrew S Levey, John J V McMurray, Giuseppe Remuzzi, Ajay K Singh, Scott D Solomon, Robert D Toto, Patrick Parfrey
BACKGROUND: The pathogenesis of chronic kidney disease associated anemia is multifactorial and includes decreased production of erythropoietin (EPO), iron deficiency, inflammation, and EPO resistance. To better understand the trajectory of these parameters, we described temporal trends in hemoglobin (Hb), ferritin, transferrin saturation, C-reactive protein (CRP), and darbepoetin dosing in the Trial to Reduce cardiovascular Events with Aranesp Therapy (TREAT). METHODS: We performed a post hoc analysis of 4,038 participants in TREAT...
2017: American Journal of Nephrology
https://read.qxmd.com/read/28599901/esrd-after-heart-failure-myocardial-infarction-or-stroke-in-type-2-diabetic-patients-with-ckd
#8
JOURNAL ARTICLE
David M Charytan, Scott D Solomon, Peter Ivanovich, Giuseppe Remuzzi, Mark E Cooper, Janet B McGill, Hans-Henrik Parving, Patrick Parfrey, Ajay K Singh, Emmanuel A Burdmann, Andrew S Levey, Dick de Zeeuw, Kai-Uwe Eckardt, John J V McMurray, Brian Claggett, Eldrin F Lewis, Marc A Pfeffer
BACKGROUND: How cardiovascular (CV) events affect progression to end-stage renal disease (ESRD), particularly in the setting of type 2 diabetes, remains uncertain. STUDY DESIGN: Observational study. SETTING & PARTICIPANTS: 4,022 patients with type 2 diabetes, anemia, and chronic kidney disease from the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). PREDICTOR: Postrandomization CV events. OUTCOMES: ESRD (defined as initiation of dialysis for >30 days, kidney transplantation, or refusal or nonavailability of renal replacement therapy) and post-ESRD mortality within 30 days and during overall follow-up after an intercurrent CV event...
October 2017: American Journal of Kidney Diseases
https://read.qxmd.com/read/27646425/c-reactive-protein-and-risk-of-esrd-results-from-the-trial-to-reduce-cardiovascular-events-with-aranesp-therapy-treat
#9
RANDOMIZED CONTROLLED TRIAL
Finnian R Mc Causland, Brian Claggett, Emmanuel A Burdmann, Kai-Uwe Eckardt, Reshma Kewalramani, Andrew S Levey, John J V McMurray, Patrick Parfrey, Giuseppe Remuzzi, Ajay K Singh, Scott D Solomon, Robert D Toto, Marc A Pfeffer
BACKGROUND: To better understand a potential association of elevated C-reactive protein (CRP) level with progression of chronic kidney disease (CKD), we examined the relationship of CRP level with the development of end-stage renal disease (ESRD) in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). STUDY DESIGN: Post hoc analysis of a randomized controlled trial. SETTING & PARTICIPANTS: 4,038 patients with type 2 diabetes, CKD, and anemia in TREAT...
December 2016: American Journal of Kidney Diseases
https://read.qxmd.com/read/27282622/purification-and-characterization-of-recombinant-darbepoetin-alfa-from-leishmania-tarentolae
#10
JOURNAL ARTICLE
Anvarsadat Kianmehr, Abdolkarim Mahrooz, Morteza Oladnabi, Yaghoub Safdari, Javad Ansari, Kamal Veisi, Mehdi Evazalipour, Hamid Shahbazmohammadi, Eskandar Omidinia
Darbepoetin alfa is a biopharmaceutical glycoprotein that stimulates erythropoiesis and is used to treat anemia, which associated with renal failure and cancer chemotherapy. We herein describe the structural characterization of recombinant darbepoetin alfa produced by Leishmania tarentolae T7-TR host. The DNA expression cassette was integrated into the L. tarentolae genome through homologous recombination. Transformed clones were selected by antibiotic resistance, diagnostic PCRs, and protein expression analysis...
September 2016: Molecular Biotechnology
https://read.qxmd.com/read/27108247/coronary-artery-disease-is-a-predictor-of-progression-to-dialysis-in-patients-with-chronic-kidney-disease-type-2-diabetes-mellitus-and-anemia-an-analysis-of-the-trial-to-reduce-cardiovascular-events-with-aranesp-therapy-treat
#11
RANDOMIZED CONTROLLED TRIAL
Marwa A Sabe, Brian Claggett, Emmanuel A Burdmann, Akshay S Desai, Peter Ivanovich, Reshma Kewalramani, Eldrin F Lewis, John J V McMurray, Kurt A Olson, Patrick Parfrey, Scott D Solomon, Marc A Pfeffer
BACKGROUND: Although clear evidence shows that chronic kidney disease is a predictor of cardiovascular events, death, and accelerated coronary artery disease (CAD) progression, it remains unknown whether CAD is a predictor of progression of chronic kidney disease to end-stage renal disease. We sought to assess whether CAD adds prognostic information to established predictors of progression to dialysis in patients with chronic kidney disease, diabetes, and anemia. METHODS AND RESULTS: Using the previously described Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) population, we compared baseline characteristics of patients with and without CAD...
April 23, 2016: Journal of the American Heart Association
https://read.qxmd.com/read/26936784/polycythemia-and-high-levels-of-erythropoietin-in-blood-and-brain-blunt-the-hypercapnic-ventilatory-response-in-adult-mice
#12
JOURNAL ARTICLE
Clément Menuet, Hanan Khemiri, Théodora de la Poëze d'Harambure, Christian Gestreau
Changes in arterial Po2, Pco2, and pH are the strongest stimuli sensed by peripheral and central chemoreceptors to adjust ventilation to the metabolic demand. Erythropoietin (Epo), the main regulator of red blood cell production, increases the hypoxic ventilatory response, an effect attributed to the presence of Epo receptors in both carotid bodies and key brainstem structures involved in integration of peripheral inputs and control of breathing. However, it is not known whether Epo also has an effect on the hypercapnic chemoreflex...
May 15, 2016: American Journal of Physiology. Regulatory, Integrative and Comparative Physiology
https://read.qxmd.com/read/26533724/economic-evaluation-of-the-aranesp-application-for-anemia-correction-in-pathients-with-chronical-renal-failure-on-hemodialysis-or-peritoneal-dialysis-in-russia
#13
JOURNAL ARTICLE
T S Fakeeva, I Krysanov
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://read.qxmd.com/read/26423928/increased-risk-of-stroke-with-darbepoetin-alfa-in-anaemic-heart-failure-patients-with-diabetes-and-chronic-kidney-disease
#14
RANDOMIZED CONTROLLED TRIAL
Natalie A Bello, Eldrin F Lewis, Akshay S Desai, Inder S Anand, Henry Krum, John J V McMurray, Kurt Olson, Scott D Solomon, Karl Swedberg, Dirk J van Veldhuisen, James B Young, Marc A Pfeffer
AIMS: The use of an erythropoesis-stimulating agent, darbepoetin alfa (DA), to treat anaemia in patients with diabetes mellitus and chronic kidney disease was associated with a heightened risk of stroke and neutral efficacy in the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), despite epidemiological data suggesting the contrary. However, this association has not been evaluated in another randomized, placebo-controlled trial. METHODS AND RESULTS: Reduction of Events by Darbepoetin Alfa in Heart Failure (RED-HF) was a randomized placebo-controlled trial of DA in 2278 patients with systolic heart failure and anaemia, enrolled from 2006 to 2012 and followed for a median of 28 months...
November 2015: European Journal of Heart Failure
https://read.qxmd.com/read/26381503/how-the-target-hemoglobin-of-renal-anemia-should-be
#15
REVIEW
Imari Mimura, Tetsuhiro Tanaka, Masaomi Nangaku
Renal anemia is caused by the deficiency of endogenous erythropoietin (Epo) due to renal dysfunction. We think that it is possible to slow the progression of chronic kidney disease (CKD) in case we initiate Epo early in pre-dialysis patients, especially in the non-diabetic population. Erythropoiesis stimulating agent (ESA) treatments targeting mild anemia (10-12 g/dl) can decrease the risk of occurrence of cardiovascular disease (CVD) in patients with hypertension, diabetes mellitus and congestive heart failure...
2015: Nephron
https://read.qxmd.com/read/26290355/identification-of-recombinant-human-epo-variants-in-greyhound-plasma-and-urine-by-elisa-lc-ms-ms-and-western-blotting-a-comparative-study
#16
JOURNAL ARTICLE
Mark Timms, Rohan Steel, John Vine
The recombinant human erythropoietins epoetin alfa (Eprex®), darbepoetin (Aranesp®) and methoxy polyethylene glycol-epoetin beta (Mircera®) were administered to greyhounds for 7, 10 and 14 days respectively. Blood and urine samples were collected and analysed for erythropoietin by ELISA, LC-MS/MS and western blotting. Limits of confirmation in plasma for western blotting and LC-MS/MS methods ranged from a low of 2.5mIU/mL, and closely matched the sensitivity of ELISA screening.
February 2016: Drug Testing and Analysis
https://read.qxmd.com/read/26177629/fusion-proteins-for-half-life-extension-of-biologics-as-a-strategy-to-make-biobetters
#17
REVIEW
William R Strohl
The purpose of making a "biobetter" biologic is to improve on the salient characteristics of a known biologic for which there is, minimally, clinical proof of concept or, maximally, marketed product data. There already are several examples in which second-generation or biobetter biologics have been generated by improving the pharmacokinetic properties of an innovative drug, including Neulasta(®) [a PEGylated, longer-half-life version of Neupogen(®) (filgrastim)] and Aranesp(®) [a longer-half-life version of Epogen(®) (epoetin-α)]...
August 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/25935581/cause-of-death-in-patients-with-diabetic-ckd-enrolled-in-the%C3%A2-trial-to-reduce-cardiovascular-events-with-aranesp-therapy%C3%A2-treat
#18
RANDOMIZED CONTROLLED TRIAL
David M Charytan, Eldrin F Lewis, Akshay S Desai, Larry A Weinrauch, Peter Ivanovich, Robert D Toto, Brian Claggett, Jiankang Liu, L Howard Hartley, Peter Finn, Ajay K Singh, Andrew S Levey, Marc A Pfeffer, John J V McMurray, Scott D Solomon
BACKGROUND: The cause of death in patients with chronic kidney disease (CKD) varies with CKD severity, but variation has not been quantified. STUDY DESIGN: Retrospective analysis of prospective randomized clinical trial. SETTING & PARTICIPANTS: We analyzed 4,038 individuals with anemia and diabetic CKD from TREAT, a randomized trial comparing darbepoetin alfa and placebo. PREDICTORS: Baseline estimated glomerular filtration rate (eGFR) and protein-creatinine ratio (PCR)...
September 2015: American Journal of Kidney Diseases
https://read.qxmd.com/read/25810068/pulse-pressure-is-not-an-independent-predictor-of-outcome-in-type-2-diabetes-patients-with-chronic-kidney-disease-and-anemia-the-trial-to-reduce-cardiovascular-events-with-aranesp-therapy-treat
#19
RANDOMIZED CONTROLLED TRIAL
S Theilade, B Claggett, T W Hansen, H Skali, E F Lewis, S D Solomon, H-H Parving, M Pfeffer, J J McMurray, P Rossing
Pulse pressure (PP) remains an elusive cardiovascular risk factor with inconsistent findings. We clarified the prognostic value in patients with type 2 diabetes, chronic kidney disease (CKD) and anemia in the Trial to Reduce cardiovascular Events with Aranesp (darbepoetin alfa) Therapy. In 4038 type 2 diabetes patients, darbepoetin alfa treatment did not affect the primary outcome. Risk related to PP at randomization was evaluated in a multivariable model including age, gender, kidney function, cardiovascular disease (CVD) and other conventional risk factors...
January 2016: Journal of Human Hypertension
https://read.qxmd.com/read/25546912/-comparison-of-the-iron-metabolism-and-effectiveness-of-anemia-treatment-in-patients-on-maintenance-hemodialysis-performed-based-on-polysulfone-and-helixone-dialyzers
#20
COMPARATIVE STUDY
Magdalena Sobaszek-Pitas, Katarzyna Krzanowska, Władysław Sułowicz
INTRODUCTION: Anemia is a common complication in patients with chronic renal failure (CRF) especially on maintenance hemodialysis. There are some data that the use of biocompatible high-flux dialyzers is more efficient than low-flux dialyzers in controlling some uremia related diseases including anemia. The aim of the study was to assess the iron metabolism and degree of anemia correction in patients on maintenance hemodialysis performed based on low-flux dialyzers (HD-LF), with polysulfone membrane and high- flux dialyzers (HD-HF), with helixone membrane...
2014: Przegla̧d Lekarski
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