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Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis.

Publication ,  Journal Article
Wolf, M; Block, GA; Chertow, GM; Cooper, K; Fouqueray, B; Moe, SM; Sun, Y; Tomlin, H; Vervloet, M; Oberbauer, R
Published in: Clin Kidney J
February 2020

BACKGROUND: Etelcalcetide is an intravenous calcimimetic approved for treatment of secondary hyperparathyroidism (sHPT) in patients receiving hemodialysis. Besides lowering parathyroid hormone (PTH), etelcalcetide also significantly reduces fibroblast growth factor 23 (FGF23), but the mechanisms are unknown. METHODS: To investigate potential mediators of etelcalcetide-induced FGF23 reduction, we performed secondary analyses of the 26-week randomized trials that compared the effects on PTH of etelcalcetide (n = 509) versus placebo (n = 514) and etelcalcetide (n = 340) versus cinacalcet (n = 343) in adults with sHPT receiving hemodialysis. We analyzed changes in FGF23 in relation to changes in PTH, calcium, phosphate and bone turnover markers. We also investigated how concomitant treatments aimed at mitigating hypocalcemia altered the FGF23-lowering effects of etelcalcetide. RESULTS: Etelcalcetide reduced FGF23 [median % change (quartile 1-quartile 3)] from baseline to the end of the trial significantly more than placebo [-56% (-85 to -7) versus +2% (-40 to +65); P < 0.001] and cinacalcet [-68% (-87 to -26) versus -41% (-76 to +25); P < 0.001]. Reductions in FGF23 correlated strongly with reductions in calcium and phosphate, but not with PTH; correlations with bone turnover markers were inconsistent and of borderline significance. Increases in concomitant vitamin D administration partially attenuated the FGF23-lowering effect of etelcalcetide, but increased dialysate calcium concentration versus no increase and increased dose of calcium supplementation versus no increase did not attenuate the FGF23-lowering effects of etelcalcetide. CONCLUSION: These data suggest that etelcalcetide potently lowers FGF23 in patients with sHPT receiving hemodialysis and that the effect remains detectable among patients who receive concomitant treatments aimed at mitigating treatment-associated decreases in serum calcium.

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Published In

Clin Kidney J

DOI

ISSN

2048-8505

Publication Date

February 2020

Volume

13

Issue

1

Start / End Page

75 / 84

Location

England

Related Subject Headings

  • 3202 Clinical sciences
 

Citation

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Chicago
ICMJE
MLA
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Wolf, M., Block, G. A., Chertow, G. M., Cooper, K., Fouqueray, B., Moe, S. M., … Oberbauer, R. (2020). Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J, 13(1), 75–84. https://doi.org/10.1093/ckj/sfz034
Wolf, Myles, Geoffrey A. Block, Glenn M. Chertow, Kerry Cooper, Bruno Fouqueray, Sharon M. Moe, Yan Sun, Holly Tomlin, Marc Vervloet, and Rainer Oberbauer. “Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis.Clin Kidney J 13, no. 1 (February 2020): 75–84. https://doi.org/10.1093/ckj/sfz034.
Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, et al. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2020 Feb;13(1):75–84.
Wolf, Myles, et al. “Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis.Clin Kidney J, vol. 13, no. 1, Feb. 2020, pp. 75–84. Pubmed, doi:10.1093/ckj/sfz034.
Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2020 Feb;13(1):75–84.

Published In

Clin Kidney J

DOI

ISSN

2048-8505

Publication Date

February 2020

Volume

13

Issue

1

Start / End Page

75 / 84

Location

England

Related Subject Headings

  • 3202 Clinical sciences