Etelcalcetide (calcimimetic) for the Treatment of Secondary Hyperparathyroidism (SHPT)

Etelcalcetide (formerly AMG416), an intravenous injectable calcimimetic agent, is currently under development by Amgen for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on haemodialysis.
Source: Drug Development Technology - Category: Pharmaceuticals Source Type: news

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Secondary hyperparathyroidism (SHPT) leads to cardiovascular calcification, which affects survival and quality of life in patients with chronic kidney disease. Cinacalcet is used to control SHPT, but it may induce gastrointestinal symptoms, resulting in lower adherence and insufficient dosages. Therefore, a need exists to develop new calcimimetics that cause fewer gastrointestinal symptoms. Here we conducted a phase 3, randomized, double-blind, double-dummy trial for a head-to-head comparison of the efficacy and safety of evocalcet, a new oral calcimimetic, to the established cinacalcet.
Source: Kidney International - Category: Urology & Nephrology Authors: Tags: Clinical Trial Source Type: research
Authors: Patel J, Bridgeman MB Abstract Etelcalcetide (Parsabiv) for hyperparathyroidism in adults with chronic kidney disease on hemodialysis. PMID: 30013296 [PubMed]
Source: P and T - Category: Drugs & Pharmacology Tags: P T Source Type: research
Conclusions: (1) Six-month treatment based on cinacalcet seems to reduce oxidative stress markers in maintenance hemodialysis patients with sHPT. (2) This benefit may be related rather to the direct action of cinacalcet than to the serum PTH concentration decrease.Nephron
Source: Nephron - Category: Urology & Nephrology Source Type: research
This article describes the ERG’s review and critique of the company’s submission and summarises the NICE Appraisal Committee’s subsequent guidance (issued in June 2017). The clinical-effectiveness evidence submitted by the company consisted of two double-blind, randomised cont rolled trials (RCTs) comparing etelcalcetide with placebo, one RCT comparing etelcalcetide with cinacalcet, two single-arm extension studies of the above trials, and one single-arm study evaluating the effect of switching from cinacalcet to etelcalcetide. No study specifically examined the populatio n specified in the NICE appraisal...
Source: PharmacoEconomics - Category: Health Management Source Type: research
Brachyonychia is a rare manifestation in patients with chronic kidney disease. Longtime disease, secondary hyperparathyroidism, and hemodialysis are common conditions among those who present it. We evaluated 8 cases who presented brachyonychia in the nephrology department and compared the clinical versus the radiographic findings, and evaluated how the tissue adjusts to the underlying bone structure, giving different forms to the nails. We conclude that brachyonychia and acroosteolysis in chronic kidney disease suggest long-term disease, secondary hyperparathyroidism, and hemodialysis, besides it being a good model on how ...
Source: Skin Appendage Disorders - Category: Dermatology Source Type: research
Abstract More than half of all deaths among end stage renal disease (ESRD) patients are due to cardiovascular disease (CVD). Cardiovascular changes secondary to renal dysfunction, including fluid overload, uremic cardiomyopathy, secondary hyperparathyroidism, anemia, altered lipid metabolism, and accumulation of gut microbiota-derived uremic toxins like trimethylamine N-oxidase, contribute to the high risk for CVD in the ESRD population. In addition, conventional hemodialysis (HD) itself poses myocardial stress and injury on the already compromised cardiovascular system in uremic patients. This review will provide...
Source: Seminars in Dialysis - Category: Urology & Nephrology Authors: Tags: Semin Dial Source Type: research
Abstract Etelcalcetide, a d-amino acid peptide, is an intravenous calcimimetic approved for the treatment of secondary hyperparathyroidism. Etelcalcetide binds the calcium-sensing receptor and increases its sensitivity to extracellular calcium, thereby decreasing secretion of parathyroid hormone (PTH) by chief cells. Etelcalcetide and its low-molecular-weight transformation products are rapidly cleared by renal excretion in healthy subjects, but clearance is substantially reduced and dependent on hemodialysis in end-stage renal disease. The effective half-life is 3-5 days in patients undergoing hemodialysis 3 time...
Source: The Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Authors: Tags: J Clin Pharmacol Source Type: research
AbstractEvaluation of bone is of great importance in chronic kidney disease patients, as these patients are at an increased risk for fractures. We treated a hemodialysis patient suffering from hyperparathyroid bone disease with cinacalcet hydrochloride and concurrent administration of maxacalcitol and alfacalcidol for a year. Hyperparathyroid bone disease is characterized by cortical thinning, increased cortical porosity, reduced trabecular bone volume, and increased hypomineralized matrix volume, and there is little information to date about the effects of treatment with cinacalcet hydrochloride on the bone fragility in p...
Source: Osteoporosis International - Category: Orthopaedics Source Type: research
The objective of this study was to explore associations between polymorphisms in the feline CaSR (fCaSR) and biochemical changes observed in CKD-MBD. Client owned cats (≥9years) were retrospectively included. SNP discovery was performed in 20 cats with azotaemic CKD and normal or dysregulated calcium concentrations. Non-pedigree cats (n=192) (125 with azotaemic CKD and 66 healthy), Persians (n=40) and Burmese (n=25) were genotyped for all identified SNPs using KASP. Biochemical parameters from the date of CKD diagnosis or from first visit to the clinic (healthy cats) were used. Associations between genotype and ionized ...
Source: The Veterinary Journal - Category: Veterinary Research Source Type: research
Conclusion: Switching daily alfacalcidol therapy to thrice-weekly alfacalcidol pulse therapy seems safe and convenient, especially for hemodialysis patients with poor compliance with treatment. This study also highlights the importance of monitoring and preventing malnutrition in hemodialysis patients and maintaining optimal glycemic control in diabetic hemodialysis patients. PMID: 29391823 [PubMed]
Source: International Journal of Nephrology and Renovascular Disease - Category: Urology & Nephrology Tags: Int J Nephrol Renovasc Dis Source Type: research
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