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One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism.
Nephrol Dial Transplant. 2020 10 01; 35(10):1769-1778.ND

Abstract

BACKGROUND

Secondary hyperparathyroidism (sHPT), a common complication of chronic kidney disease, is characterized by elevated serum parathyroid hormone (PTH). Etelcalcetide is an intravenous calcimimetic that increases sensitivity of the calcium-sensing receptor to calcium and decreases PTH secretion. This open-label extension (OLE) trial evaluated the long-term effects of etelcalcetide for sHPT treatment in patients receiving hemodialysis.

METHODS

This 52-week, multicenter, single-arm OLE enrolled patients from three parent trials: two randomized, double-blind, placebo-controlled trials and one open-label, single-arm, 'switch' study from cinacalcet to etelcalcetide. The primary endpoint was to investigate the nature, frequency, severity and relation to treatment of all adverse events (AEs) reported throughout the trial. Secondary endpoints included the proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product (Ca × P).ClinicalTrials.gov identifier: NCT01785875; Amgen study: 20120231.

RESULTS

Overall, 89.8% of the patients experienced one or more treatment-emergent AE. The most common were decreased blood Ca (43.3%), diarrhea (10.8%), vomiting (10.4%) and nausea (9.6%); symptomatic hypocalcemia occurred in 3.7% of the patients. Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.

CONCLUSIONS

Etelcalcetide effectively lowered PTH and its effect was sustained, while no new safety concerns emerged over a 1-year treatment period.

Authors+Show Affiliations

Department of Medicine, Division of Nephrology, University of Rochester School of Medicine, Rochester, NY, USA.Department of Medicine, Division of Nephrology, Stanford University, Stanford, CA, USA.Clinical Development, Amgen Inc., Thousand Oaks, CA, USA.Biostatistics, Amgen Inc., Thousand Oaks, CA, USA.Department of Medicine, Division of Nephrology, Lehigh Valley Hospital, Allentown, PA, USA.Department of Internal Medicine, Division of Nephrology, Saint Louis University School of Medicine, St Louis, MO, USA.Department of Medicine, Division of Nephrology, University of California, Los Angeles, Los Angeles, CA, USA.Department of Nephrology and Dialysis, Ramsay-Générale de Santé, Clinique du Landy, Saint Ouen, France and Necker Hospital, University of Paris Descartes, Paris, France.Department of Nephrology and Amsterdam Cardiovascular Sciences, VU University Medical Center, Amsterdam, The Netherlands.Denver Nephrology, Denver, CO, USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30859218

Citation

Bushinsky, David A., et al. "One-year Safety and Efficacy of Intravenous Etelcalcetide in Patients On Hemodialysis With Secondary Hyperparathyroidism." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 35, no. 10, 2020, pp. 1769-1778.
Bushinsky DA, Chertow GM, Cheng S, et al. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol Dial Transplant. 2020;35(10):1769-1778.
Bushinsky, D. A., Chertow, G. M., Cheng, S., Deng, H., Kopyt, N., Martin, K. J., Rastogi, A., Ureña-Torres, P., Vervloet, M., & Block, G. A. (2020). One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 35(10), 1769-1778. https://doi.org/10.1093/ndt/gfz039
Bushinsky DA, et al. One-year Safety and Efficacy of Intravenous Etelcalcetide in Patients On Hemodialysis With Secondary Hyperparathyroidism. Nephrol Dial Transplant. 2020 10 1;35(10):1769-1778. PubMed PMID: 30859218.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. AU - Bushinsky,David A, AU - Chertow,Glenn M, AU - Cheng,Sunfa, AU - Deng,Hongjie, AU - Kopyt,Nelson, AU - Martin,Kevin J, AU - Rastogi,Anjay, AU - Ureña-Torres,Pablo, AU - Vervloet,Marc, AU - Block,Geoffrey A, PY - 2018/10/17/received PY - 2019/01/21/accepted PY - 2019/3/13/pubmed PY - 2021/1/13/medline PY - 2019/3/13/entrez KW - chronic kidney disease KW - etelcalcetide KW - open-label extension KW - safety, secondary hyperparathyroidism SP - 1769 EP - 1778 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 35 IS - 10 N2 - BACKGROUND: Secondary hyperparathyroidism (sHPT), a common complication of chronic kidney disease, is characterized by elevated serum parathyroid hormone (PTH). Etelcalcetide is an intravenous calcimimetic that increases sensitivity of the calcium-sensing receptor to calcium and decreases PTH secretion. This open-label extension (OLE) trial evaluated the long-term effects of etelcalcetide for sHPT treatment in patients receiving hemodialysis. METHODS: This 52-week, multicenter, single-arm OLE enrolled patients from three parent trials: two randomized, double-blind, placebo-controlled trials and one open-label, single-arm, 'switch' study from cinacalcet to etelcalcetide. The primary endpoint was to investigate the nature, frequency, severity and relation to treatment of all adverse events (AEs) reported throughout the trial. Secondary endpoints included the proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product (Ca × P).ClinicalTrials.gov identifier: NCT01785875; Amgen study: 20120231. RESULTS: Overall, 89.8% of the patients experienced one or more treatment-emergent AE. The most common were decreased blood Ca (43.3%), diarrhea (10.8%), vomiting (10.4%) and nausea (9.6%); symptomatic hypocalcemia occurred in 3.7% of the patients. Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P. CONCLUSIONS: Etelcalcetide effectively lowered PTH and its effect was sustained, while no new safety concerns emerged over a 1-year treatment period. SN - 1460-2385 UR - https://wwww.unboundmedicine.com/medline/citation/30859218/One_year_safety_and_efficacy_of_intravenous_etelcalcetide_in_patients_on_hemodialysis_with_secondary_hyperparathyroidism_ L2 - https://academic.oup.com/ndt/article-lookup/doi/10.1093/ndt/gfz039 DB - PRIME DP - Unbound Medicine ER -