Etelcalcetide (secondary hyperparathyroidism) - Addendum to Commission A17-25 1 Translation of addendum A17-53 Etelcalcetid (sekundärer Hyperparathyreoidismus) – Addendum zum Auftrag A17-25 (Version 1.0; Status: 27 October 2017). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 27 October 2017 1.0 Commission: A17-53 Version: Status: IQWiG Reports – Commission No. A17-53 Etelcalcetide (secondary hyperparathyroidism – Addendum to Commission A17-251 Addendum A17-53 Version 1.0 Etelcalcetide – Addendum to Commission A17-25 27 October 2017 Institute for Quality
Incorporation of Calcimimetics into ESRD Bundle: Changes in Etelcalcetide Utilization and PTH Control Following End of TDAPA Designation. Calcimimetics, including intravenous etelcalcetide and oral cinacalcet, are often prescribed to hemodialysis patients to prevent complications of elevated parathyroid hormone (PTH) levels. In January 2021, US dialysis reimbursement policy switched from the transitional drug add-on payment adjustment (TDAPA) to an increased bundled payment, with $10.09 per session added for all hemodialysis patients to cover the expense for calcimimetics, whether or not patients are administered etelcalcetide. We leveraged this natural experiment to investigate the impact of this policy change. This analysis included 713 US in-center hemodialysis patients enrolled in the United
Etelcalcetide (secondary hyperparathyroidism) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Etelcalcetid (sekundärer Hyperparathyreoidis-mus) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 30 August 2017). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A17-25 Etelcalcetide (secondary hyperparathyroidism) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A17-25 Version 1.0 Etelcalcetide (secondary hyperparathyroidism) 30 August 2017
Etelcalcetide (Parsabiv) - To treat secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis Parsabiv (etelcalcetide) Injection * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDAParsabiv (etelcalcetide) Injection * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print ParsabivCompany: Amgen
Etelcalcetide Inhibits the Progression of Left Atrial Volume Index Compared to Alfacalcidol in Hemodialysis Patients. Increased left atrial (LA) size is a risk factor for cardiovascular events and all-cause mortality. It is closely related to left ventricular hypertrophy and chronic volume overload, both of which are common in hemodialysis. Calcimimetic treatment with etelcalcetide (ETL
Changes in Bone Quality after Treatment with Etelcalcetide. Secondary hyperparathyroidism is associated with osteoporosis and fractures. Etelcalcetide is an intravenous calcimimetic for control of hyperparathyroidism in patients on hemodialysis. Effects of etelcalcetide on the skeleton are unknown. In a single-arm, open-label, 36-week prospective trial we hypothesized that etelcalcetide improves /year; p<0.01). Treatment with etelcalcetide for 36-weeks was associated with improvements in central skeleton areal bone mineral density and trabecular quality and lowered bone turnover without affecting bone material properties.
Effect of etelcalcetide versus alfacalcidol on left ventricular function and feature-tracking cardiac magnetic resonance imaging in hemodialysis-a post-hoc analysis of a randomized, controlled trial. Calcimimetic therapy with etelcalcetide (ETEL) has been shown to attenuate the advancement of left ventricular (LV) hypertrophy in hemodialysis patients measured by cardiac magnetic resonance (CMR
[Etelcalcetide (secondary hyperparathyroidism) - benefit assessment according to õ35a Social Code Book V] Etelcalcetid (sekundärer Hyperparathyreoidismus): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-25 [Etelcalcetide (secondary hyperparathyroidism) - benefit assessment according to §35a Social Code Book V ] ..
Bone Specific Alkaline Phosphatase and Serum Calcification Propensity Are Not Influenced by Etelcalcetide vs. Alfacalcidol Treatment, and Only Bone Specific Alkaline Phosphatase Is Correlated With Fibroblast Growth Factor 23: Sub-Analysis Results of the Secondary hyperparathyroidism in chronic kidney disease poses a major risk factor for vascular calcification and high bone turnover, leading to mineralization defects. The aim was to analyze the effect of active vitamin D and calcimimetic treatment on fibroblast growth factor 23 (FGF23), serum calcification propensity (T50), a surrogate marker of calcification stress and bone specific alkaline phosphatase (BAP) in hemodialysis. This is a subanalysis of a randomized trial comparing etelcalcetide vs. alfacalcidol in 62 hemodialysis patients for 1 year
Lessons from effect of etelcalcetide on left ventricular hypertrophy in patients with end-stage kidney disease. Patients with end-stage kidney disease (ESKD) frequently develop left ventricular hypertrophy (LVH), which is associated with an exceptionally high risk of cardiovascular events and mortality. This review focuses on interventional studies that modify levels of fibroblast growth factor 23 (FGF23) and examine effects on myocardial hypertrophy, cardiovascular events and mortality. Quantitative evaluations of trials of calcimimetics found no effects on cardiovascular events and cardiovascular and all-cause mortality when compared with placebo. However, a recent randomized, controlled trial of etelcalcetide versus alfacalcidol showed that etelcalcetide effectively inhibited
Etelcalcetide Utilization, Dosing Titration, and Chronic Kidney Disease-Mineral and Bone Disease (CKD-MBD) Marker Responses in US Hemodialysis Patients. Clinical trial data have demonstrated the efficacy of etelcalcetide for reducing parathyroid hormone (PTH) levels in hemodialysis (HD) patients. We provide a real-world summary of etelcalcetide utilization, dosing, effectiveness , and discontinuation since its US introduction in April 2017. New-user design within prospective cohort. 2,596 new users of etelcalcetide from April 2017 through August 2019 in a national sample of adult maintenance HD patients in the US Dialysis Outcomes and Practice Patterns Study (DOPPS). Baseline PTH, prior cinacalcet use, initial etelcalcetide dose. Trajectories of etelcalcetide dose, chronic kidney disease
Impact of etelcalcetide on fibroblast growth factor-23 and calciprotein particles in patients with secondary hyperparathyroidism undergoing haemodialysis. Recently, we demonstrated the efficacy of etelcalcetide in the control of secondary hyperparathyroidism (SHPT). This post hoc analysis aimed to evaluate changes in fibroblast growth factor-23 (FGF23) and calciprotein particles (CPPs) after treatment with calcimimetics. The DUET trial was a 12-week multicenter, open-label, parallel-group, randomized (1:1:1) study with patients treated with etelcalcetide plus active vitamin D (E + D group; n = 41), etelcalcetide plus oral calcium (E + Ca group; n = 41), or control (C group; n = 42) under maintenance haemodialysis. Serum levels of FGF23 and CPPs were measured at baseline, and 6 and 12 weeks
Comparative Effects of Etelcalcetide and Maxacalcitol on Serum Calcification Propensity in Secondary Hyperparathyroidism: A Randomized Clinical Trial. Vitamin D receptor activators and calcimimetics (calcium-sensing receptor agonists) are two major options for medical treatment of secondary hyperparathyroidism. A higher serum calcification propensity (a shorter T value) is a novel surrogate marker of calcification stress and mortality in patients with CKD. We tested a hypothesis that a calcimimetic agent etelcalcetide is more effective in increasing T value than a vitamin D receptor activator maxacalcitol. A randomized, multicenter, open-label, blinded end point trial with active control was conducted in patients with secondary hyperparathyroidism undergoing hemodialysis in Japan
A Phase I, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Etelcalcetide Administered Intravenously to Chinese Patients With Chronic Kidney Disease Undergoing Hemodialysis. This study reports data from the first evaluation of etelcalcetide treatment in Chinese adults with chronic kidney disease and secondary hyperparathyroidism. This phase I, randomized study compared thrice-weekly etelcalcetide (5 mg per dose intravenously) and placebo in 33 Chinese adults (aged 18-70 years) receiving hemodialysis. Patients in both treatment groups received standard-of-care treatment with a total of 12 doses of the investigational product during a 4-week treatment period, followed by 4 weeks of washout and follow-up. Pharmacokinetic
Etelcalcetide An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM during LactationNo information is available on etelcalcetide during breastfeeding. Because etelcalcetide is a large molecule with a molecular weight of 1047.5 Da, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be avoided during use. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.Drug LevelsMaternal Levels. Relevant