PMID- 30859218
OWN - NLM
STAT- MEDLINE
DCOM- 20210112
LR  - 20210112
IS  - 1460-2385 (Electronic)
IS  - 0931-0509 (Print)
IS  - 0931-0509 (Linking)
VI  - 35
IP  - 10
DP  - 2020 Oct 1
TI  - One-year safety and efficacy of intravenous etelcalcetide in patients on 
      hemodialysis with secondary hyperparathyroidism.
PG  - 1769-1778
LID - 10.1093/ndt/gfz039 [doi]
AB  - 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 x 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  approximately 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 x P. CONCLUSIONS: 
      Etelcalcetide effectively lowered PTH and its effect was sustained, while no new 
      safety concerns emerged over a 1-year treatment period.
CI  - (c) The Author(s) 2019. Published by Oxford University Press on behalf of ERA-EDTA.
FAU - Bushinsky, David A
AU  - Bushinsky DA
AD  - Department of Medicine, Division of Nephrology, University of Rochester School of 
      Medicine, Rochester, NY, USA.
FAU - Chertow, Glenn M
AU  - Chertow GM
AD  - Department of Medicine, Division of Nephrology, Stanford University, Stanford, 
      CA, USA.
FAU - Cheng, Sunfa
AU  - Cheng S
AD  - Clinical Development, Amgen Inc., Thousand Oaks, CA, USA.
FAU - Deng, Hongjie
AU  - Deng H
AD  - Biostatistics, Amgen Inc., Thousand Oaks, CA, USA.
FAU - Kopyt, Nelson
AU  - Kopyt N
AD  - Department of Medicine, Division of Nephrology, Lehigh Valley Hospital, 
      Allentown, PA, USA.
FAU - Martin, Kevin J
AU  - Martin KJ
AD  - Department of Internal Medicine, Division of Nephrology, Saint Louis University 
      School of Medicine, St Louis, MO, USA.
FAU - Rastogi, Anjay
AU  - Rastogi A
AD  - Department of Medicine, Division of Nephrology, University of California, Los 
      Angeles, Los Angeles, CA, USA.
FAU - Urena-Torres, Pablo
AU  - Urena-Torres P
AD  - Department of Nephrology and Dialysis, Ramsay-Generale de Sante, Clinique du 
      Landy, Saint Ouen, France and Necker Hospital, University of Paris Descartes, 
      Paris, France.
FAU - Vervloet, Marc
AU  - Vervloet M
AD  - Department of Nephrology and Amsterdam Cardiovascular Sciences, VU University 
      Medical Center, Amsterdam, The Netherlands.
FAU - Block, Geoffrey A
AU  - Block GA
AD  - Denver Nephrology, Denver, CO, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01785875
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Nephrol Dial Transplant
JT  - Nephrology, dialysis, transplantation : official publication of the European 
      Dialysis and Transplant Association - European Renal Association
JID - 8706402
RN  - 0 (Parathyroid Hormone)
RN  - 0 (Peptides)
RN  - 72PT5993DU (etelcalcetide hydrochloride)
RN  - SY7Q814VUP (Calcium)
SB  - IM
EIN - Nephrol Dial Transplant. 2019 May 15;:1642. PMID: 31093680
MH  - Administration, Intravenous
MH  - Aged
MH  - Calcium/blood
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hyperparathyroidism, Secondary/*drug therapy/etiology/pathology
MH  - Male
MH  - Parathyroid Hormone/blood
MH  - Peptides/*administration & dosage
MH  - Prognosis
MH  - Renal Dialysis/*adverse effects
MH  - Renal Insufficiency, Chronic/*complications/therapy
PMC - PMC7538239
OTO - NOTNLM
OT  - chronic kidney disease
OT  - etelcalcetide
OT  - open-label extension
OT  - safety, secondary hyperparathyroidism
EDAT- 2019/03/13 06:00
MHDA- 2021/01/13 06:00
PMCR- 2019/03/11
CRDT- 2019/03/13 06:00
PHST- 2018/10/17 00:00 [received]
PHST- 2019/01/21 00:00 [accepted]
PHST- 2019/03/13 06:00 [pubmed]
PHST- 2021/01/13 06:00 [medline]
PHST- 2019/03/13 06:00 [entrez]
PHST- 2019/03/11 00:00 [pmc-release]
AID - 5374826 [pii]
AID - gfz039 [pii]
AID - 10.1093/ndt/gfz039 [doi]
PST - ppublish
SO  - Nephrol Dial Transplant. 2020 Oct 1;35(10):1769-1778. doi: 10.1093/ndt/gfz039.