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Etelcalcetide

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https://www.readbyqxmd.com/read/28671062/a-12-week-dose-escalating-study-of-etelcalcetide-ono-5163-amg-416-%C3%A2-a-novel-intravenous-calcimimetic-for-secondary-hyperparathyroidism-in-%C3%A2-japanese-hemodialysis-patients%C3%A2
#1
Keitaro Yokoyama, Masafumi Fukagawa, Takashi Shigematsu, Takashi Akiba, Akifumi Fujii, Motoi Odani, Tadao Akizawa
AIMS: To evaluate dose-escalation of etelcalcetide (ONO-5163/AMG 416), a novel, intravenous (IV), long-acting calcium-sensing receptor agonist, for treatment of secondary hyperparathyroidism (SHPT) in Japanese hemodialysis patients. MATERIALS AND METHODS: In this multicenter study, IV injections of etelcalcetide (3 times a week for 12 weeks) were administered, with dose escalation every 4 weeks depending on changes in serum intact parathyroid hormone (iPTH) and corrected calcium (cCa)...
July 3, 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/28615947/treatment-of-secondary-hyperparathyroidism-the-clinical-utility-of-etelcalcetide
#2
REVIEW
Mario Cozzolino, Andrea Galassi, Ferruccio Conte, Michela Mangano, Luca Di Lullo, Antonio Bellasi
Secondary hyperparathyroidism (SHPT), a very frequent, severe, and worsening complication of chronic kidney disease, is characterized by high serum parathyroid hormone (PTH), parathyroid gland hyperplasia, and disturbances in mineral metabolism. Clinically, SHPT shows renal osteodystrophy, vascular calcification, cardiovascular damage, and fatal outcome. Calcium-sensing receptor (CaSR) is the main physiological regulator of PTH secretion; its activation by calcium rapidly inhibits PTH. Another important player in regulating mineral metabolism is vitamin D receptor (VDR), which is under the influence of vitamin D and influences the intestinal absorption of calcium and phosphate, PTH gene expression, and bone calcium mobilization...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28535231/dosing-of-etelcalcetide-vs-cinacalcet-for-secondary-hyperparathyroidism-reply
#3
LETTER
Geoffrey A Block, Glenn M Chertow
No abstract text is available yet for this article.
May 23, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28535228/dosing-of-etelcalcetide-and-cinacalcet-for-secondary-hyperparathyroidism
#4
LETTER
Mary T Thanh Hai, Jean-Marc Guettier, Curtis J Rosebraugh
No abstract text is available yet for this article.
May 23, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28508378/population-pharmacokinetic-and-pharmacodynamic-modeling-of-etelcalcetide-in-patients-with-chronic-kidney-disease-and-secondary-hyperparathyroidism-receiving-hemodialysis
#5
Ping Chen, Adimoolam Narayanan, Benjamin Wu, Per Olsson Gisleskog, John P Gibbs, Andrew T Chow, Murad Melhem
INTRODUCTION: Etelcalcetide is a novel calcimimetic that binds and activates calcium-sensing receptors (CaSRs) for the treatment of secondary hyperparathyroidism (SHPT). METHODS: To assess titrated dosing regimens, population pharmacokinetic (PK) and PK/pharmacodynamic (PKPD) modeling of etelcalcetide was performed using NONMEM 7.2. In this analysis, plasma etelcalcetide, serum parathyroid hormone (PTH) and calcium (Ca) concentration-time data were collected from five phase I, II, and III clinical trials following single or multiple intravenous doses of etelcalcetide ranging from 2...
May 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28381914/pharmaceutical-approval-update
#6
Mary Choy
Abuse-deterrent hydrocodone bitartrate (Vantrela ER) for long-term opioid treatment; etelcalcetide (Parsabiv) for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis; and deflazacort (Emflaza) for Duchenne muscular dystrophy.
April 2017: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/28336834/-parenteral-calcimimetics-for-the-treatment-of-secondary-hyperparathyroidism
#7
Naoto Hamano, Masafumi Fukagawa
The oral calcimimetics, cinacalcet, is reported to be effective on secondary hyperparathyroidism resistant to classical treatment like phosphate binders or vitamin D receptor activator. The problem that gastrointestinal adverse events cause poor adherence, drug discontinuation, and insufficient dose escalation remains unsolved. The novel injectable calcimimetic, etelcalcetide, is recently developed and is expected to reduce such adverse events and improve the therapeutic effects on moderate to severe secondary hyperparathyroidism...
2017: Clinical Calcium
https://www.readbyqxmd.com/read/28336830/-the-discovery-research-and-development-of-etelcalcetide-hydrochloride-the-world-1st-intravenous-calcimimetics
#8
Atsuto Inoue, Kazutsune Harada
Etelcalcetide hydrochloride is the first intravenous calcimimetics agent for secondary hyperparathyroidism (SHPT). Etelcalcetide hydrochloride is to be administered through dialysis circuit by physician or medical staff upon completion of dialysis and such administration is expected to reduce the burden of medication in patients. From the nonclinical study results, etelcalcetide functions as an allosteric activator of calcium-sensing receptor(CaSR). Etelcalcetide suppressed PTH secretion both in vitro and in vivo...
2017: Clinical Calcium
https://www.readbyqxmd.com/read/28277829/etelcalcetide-for-the-treatment-of-secondary-hyperparathyroidism
#9
REVIEW
Naoto Hamano, Hirotaka Komaba, Masafumi Fukagawa
Calcium sensing receptor is an important target for the treatment of secondary hyperparathyroidism (SHPT). Etelcalcetide hydrochloride is a novel peptide calcimimetic agent that has a similar mechanism of action as cinacalcet hydrochloride. Clinical trials of etelcalcetide have been performed in the US, Europe, and Japan, and these trials demonstrated the safety and efficacy of etelcalcetide in dialysis patients. Etelcalcetide has recently been approved in Europe, the US and Japan. Areas covered: We review the development, pharmacokinetics, and clinical efficacy and safety of etelcalcetide for the treatment of SHPT in hemodialysis patients...
April 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28274835/clinical-immunogenicity-of-the-d-amino-acid-peptide-therapeutic-etelcalcetide-method-development-challenges-and-anti-drug-antibody-clinical-impact-assessments
#10
Mark A Kroenke, Dohan K Weeraratne, Hongjie Deng, Bethlyn Sloey, Raju Subramanian, Benjamin Wu, Michael Serenko, M Benjamin Hock
The immunogenicity risk assessment and bioanalytical strategy for novel therapeutics should account for both unique biophysical properties and potential consequences of immunogenicity. When assessing the immunogenicity risk of etelcalcetide, a peptide agonist of the calcium-sensing receptor, we considered the potential that the d-amino acid 'backbone' and biotransformation of etelcalcetide could allow the drug to act as a hapten. As a consequence, we validated and implemented a surface plasmon resonance immunoassay platform with both etelcalcetide and etelcalcetide-'carrier' surfaces to detect anti-drug antibodies (ADA)...
March 6, 2017: Journal of Immunological Methods
https://www.readbyqxmd.com/read/28097356/effect-of-etelcalcetide-vs-cinacalcet-on-serum-parathyroid-hormone-in-patients-receiving-hemodialysis-with-secondary-hyperparathyroidism-a-randomized-clinical-trial
#11
RANDOMIZED CONTROLLED TRIAL
Geoffrey A Block, David A Bushinsky, Sunfa Cheng, John Cunningham, Bastian Dehmel, Tilman B Drueke, Markus Ketteler, Reshma Kewalramani, Kevin J Martin, Sharon M Moe, Uptal D Patel, Justin Silver, Yan Sun, Hao Wang, Glenn M Chertow
Importance: Secondary hyperparathyroidism contributes to extraskeletal calcification and is associated with all-cause and cardiovascular mortality. Control is suboptimal in the majority of patients receiving hemodialysis. An intravenously (IV) administered calcimimetic could improve adherence and reduce adverse gastrointestinal effects. Objective: To evaluate the relative efficacy and safety of the IV calcimimetic etelcalcetide and the oral calcimimetic cinacalcet...
January 10, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28097355/effect-of-etelcalcetide-vs-placebo-on-serum-parathyroid-hormone-in-patients-receiving-hemodialysis-with-secondary-hyperparathyroidism-two-randomized-clinical-trials
#12
RANDOMIZED CONTROLLED TRIAL
Geoffrey A Block, David A Bushinsky, John Cunningham, Tilman B Drueke, Markus Ketteler, Reshma Kewalramani, Kevin J Martin, T Christian Mix, Sharon M Moe, Uptal D Patel, Justin Silver, David M Spiegel, Lulu Sterling, Liron Walsh, Glenn M Chertow
Importance: Secondary hyperparathyroidism contributes to extraskeletal complications in chronic kidney disease. Objective: To evaluate the effect of the intravenous calcimimetic etelcalcetide on serum parathyroid hormone (PTH) concentrations in patients receiving hemodialysis. Design, Setting, and Participants: Two parallel, phase 3, randomized, placebo-controlled treatment trials were conducted in 1023 patients receiving hemodialysis with moderate to severe secondary hyperparathyroidism...
January 10, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28063122/drug-disposition-model-of-radiolabeled-etelcalcetide-in-patients-with-chronic-kidney-disease-and-secondary-hyperparathyroidism-on-hemodialysis
#13
Liviawati Wu, Murad Melhem, Raju Subramanian, Benjamin Wu
Etelcalcetide (AMG 416) is an allosteric activator of the calcium-sensing receptor for treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on hemodialysis. To characterize the time course of etelcalcetide in different matrices (plasma, dialysate, urine, and feces), a drug disposition model was developed. Nonlinear mixed-effect modeling was used to describe data from six adults with CKD on hemodialysis who received a single intravenous dose of [(14)C]etelcalcetide (10 mg; 710 nCi) after hemodialysis (study NCT02054572)...
February 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28057872/a-phase-3-multicentre-randomized-double-blind-placebo-controlled-parallel-group-study-to-evaluate-the-efficacy-and-safety-of-etelcalcetide-ono-5163-amg-416-a-novel-intravenous-calcimimetic-for-secondary-hyperparathyroidism-in-japanese-haemodialysis-patients
#14
Masafumi Fukagawa, Keitaro Yokoyama, Takashi Shigematsu, Takashi Akiba, Akifumi Fujii, Takuto Kuramoto, Motoi Odani, Tadao Akizawa
BACKGROUND: Secondary hyperparathyroidism (SHPT) is a major complication associated with chronic kidney disease. We evaluated the efficacy and safety of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, in Japanese haemodialysis patients with SHPT. METHODS: In this phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study, etelcalcetide was administered three times per week at an initial dose of 5 mg, and subsequently adjusted to doses between 2...
January 5, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/27971361/assessing-the-cost-utility-of-etelcalcetide-a-markov-model
#15
B Stollenwerk, S Iannazzo, R Akehurst, M Adena, A Briggs, B Dehmel, P Parfrey, V Belozeroff
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27900648/etelcalcetide-first-global-approval
#16
REVIEW
Hannah A Blair
Etelcalcetide (Parsabiv™) is a novel second generation calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT), a complication of chronic kidney disease (CKD). Etelcalcetide reduces circulating levels of parathyroid hormone and calcium by binding directly to the calcium-sensing receptor. Intravenous etelcalcetide has been approved in the EU for the treatment of SHPT in adult patients with CKD on haemodialysis therapy. Regulatory applications for etelcalcetide in SHPT are also under review in the USA and Japan...
December 2016: Drugs
https://www.readbyqxmd.com/read/27639083/population-pharmacokinetics-and-pharmacodynamics-of-the-calcimimetic-etelcalcetide-in-chronic-kidney-disease-and-secondary-hyperparathyroidism-receiving-hemodialysis
#17
P Chen, P Olsson Gisleskog, J J Perez-Ruixo, J Xiao, J Wilkins, A Narayanan, J P Gibbs, M Melhem
Etelcalcetide is a novel calcimimetic in development for the treatment of secondary hyperparathyroidism (SHPT). A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed relating etelcalcetide exposures to markers of efficacy (parathyroid hormone [PTH]) and safety (calcium) using data from three clinical studies. The semimechanistic model was developed that included allosteric activation pharmacology and understanding of calcium homeostasis. The temporal profiles for all biomarkers were well described by the model...
September 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27517676/pharmacokinetics-biotransformation-and-excretion-of-14-c-etelcalcetide-amg-416-following-a-single-microtracer-intravenous-dose-in-patients-with-chronic-kidney-disease-on-hemodialysis
#18
Raju Subramanian, Xiaochun Zhu, M Benjamin Hock, Bethlyn J Sloey, Benjamin Wu, Sarah F Wilson, Ogo Egbuna, J Greg Slatter, Jim Xiao, Gary L Skiles
Etelcalcetide (AMG 416) is a novel synthetic peptide calcium-sensing receptor activator in clinical development as an intravenous calcimimetic for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) on hemodialysis. Etelcalcetide is composed of seven D-aminoacids with an L-cysteine linked to a D-cysteine by a disulfide bond. A single intravenous dose of [(14)C]etelcalcetide (10 mg; 26.3 kBq; 710 nCi) was administered to patients with CKD on hemodialysis to elucidate the pharmacokinetics, biotransformation, and excretion of etelcalcetide in this setting...
February 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/26941242/nonclinical-safety-profile-of-etelcalcetide-a-novel-peptide-calcimimetic-for-the-treatment-of-secondary-hyperparathyroidism
#19
Mark R Fielden, Charles Dean, Kurt Black, Satin G Sawant, Raju Subramanian, James E Tomlinson, Sarah Walter, Cameron Zimmermann, Mark W Griggs, Marie E McKeon, Elise M Lewis, Carol Beevers, Ian Pyrah
Etelcalcetide is a novel d-amino acid peptide that functions as an allosteric activator of the calcium-sensing receptor and is being developed as an intravenous calcimimetic for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. To support clinical development and marketing authorization, a comprehensive nonclinical safety package was generated. Primary adverse effects included hypocalcemia, tremoring, and convulsions. Other adverse effects were considered sequelae of stress associated with hypocalcemia...
May 2016: International Journal of Toxicology
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