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A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD.

Publication ,  Journal Article
Block, GA; Block, MS; Smits, G; Mehta, R; Isakova, T; Wolf, M; Chertow, GM
Published in: Journal of the American Society of Nephrology : JASN
August 2019

Researchers have yet to determine the optimal care of patients with advanced CKD. Evidence suggests that anemia and CKD-related disordered mineral metabolism (including abnormalities in phosphate and fibroblast growth factor 23 [FGF23]) contribute to adverse outcomes in this population.To investigate whether fixed-dose ferric citrate coordination complex favorably affects multiple biochemical parameters in patients with advanced CKD, we randomly assigned 203 patients with eGFR≤20 ml/min per 1.73 m2 2:1 to receive a fixed dose of ferric citrate coordination complex (two tablets per meal, 210 mg ferric iron per tablet) or usual care for 9 months or until 3 months after starting dialysis. No single biochemical end point was designated as primary; sample size was determined empirically.The two groups had generally similar baseline characteristics, although diabetes and peripheral vascular disease were more common in the usual-care group. Ferric citrate coordination complex significantly increased hemoglobin, transferrin saturation, and serum ferritin, and it significantly reduced serum phosphate and intact FGF23 (P<0.001 for all). Of the 133 patients randomized to ferric citrate coordination complex, 31 (23%) initiated dialysis during the study period, as did 32 of 66 (48%) patients randomized to usual care (P=0.001). Compared with usual care, ferric citrate coordination complex treatment resulted in significantly fewer annualized hospital admissions, fewer days in hospital, and a lower incidence of the composite end point of death, provision of dialysis, or transplantation (P=0.002).The beneficial effects of fixed-dose ferric citrate coordination complex on biochemical parameters, as well as the exploratory results regarding the composite end point and hospitalization, suggest that fixed-dose ferric citrate coordination complex has an excellent safety profile in an unselected population with advanced CKD and merits further study.

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Published In

Journal of the American Society of Nephrology : JASN

DOI

EISSN

1533-3450

ISSN

1046-6673

Publication Date

August 2019

Volume

30

Issue

8

Start / End Page

1495 / 1504

Related Subject Headings

  • Urology & Nephrology
  • Transferrin
  • Renal Dialysis
  • Pilot Projects
  • Phosphates
  • Patient Admission
  • Middle Aged
  • Male
  • Length of Stay
  • Kidney Failure, Chronic
 

Citation

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ICMJE
MLA
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Block, G. A., Block, M. S., Smits, G., Mehta, R., Isakova, T., Wolf, M., & Chertow, G. M. (2019). A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD. Journal of the American Society of Nephrology : JASN, 30(8), 1495–1504. https://doi.org/10.1681/asn.2018101016
Block, Geoffrey A., Martha S. Block, Gerard Smits, Rupal Mehta, Tamara Isakova, Myles Wolf, and Glenn M. Chertow. “A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD.Journal of the American Society of Nephrology : JASN 30, no. 8 (August 2019): 1495–1504. https://doi.org/10.1681/asn.2018101016.
Block GA, Block MS, Smits G, Mehta R, Isakova T, Wolf M, et al. A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD. Journal of the American Society of Nephrology : JASN. 2019 Aug;30(8):1495–504.
Block, Geoffrey A., et al. “A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD.Journal of the American Society of Nephrology : JASN, vol. 30, no. 8, Aug. 2019, pp. 1495–504. Epmc, doi:10.1681/asn.2018101016.
Block GA, Block MS, Smits G, Mehta R, Isakova T, Wolf M, Chertow GM. A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD. Journal of the American Society of Nephrology : JASN. 2019 Aug;30(8):1495–1504.

Published In

Journal of the American Society of Nephrology : JASN

DOI

EISSN

1533-3450

ISSN

1046-6673

Publication Date

August 2019

Volume

30

Issue

8

Start / End Page

1495 / 1504

Related Subject Headings

  • Urology & Nephrology
  • Transferrin
  • Renal Dialysis
  • Pilot Projects
  • Phosphates
  • Patient Admission
  • Middle Aged
  • Male
  • Length of Stay
  • Kidney Failure, Chronic