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A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD.
J Am Soc Nephrol. 2019 08; 30(8):1495-1504.JA

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

Authors+Show Affiliations

Reata Pharmaceuticals, Dallas, Texas; geoff@goldenblocks.org.Denver Nephrology Research Division, Denver, Colorado.CSC, Inc., Santa Barbara, California.Division of Nephrology and Hypertension, Department of Medicine and Center for Translational Metabolism and Health, Institute of Public Health and Medicine, Feinberg School of Medicine, Jesse Brown Veterans Administration Medical Center.Division of Nephrology and Hypertension, Department of Medicine and Center for Translational Metabolism and Health, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.Division of Nephrology, Department of Medicine, and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; and.Stanford University, Palo Alto, California.

Pub Type(s)

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

Language

eng

PubMed ID

31278194

Citation

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, 2019, pp. 1495-1504.
Block GA, Block MS, Smits G, et al. A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD. J Am Soc Nephrol. 2019;30(8):1495-1504.
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 GA, et al. A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD. J Am Soc Nephrol. 2019;30(8):1495-1504. PubMed PMID: 31278194.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD. AU - Block,Geoffrey A, AU - Block,Martha S, AU - Smits,Gerard, AU - Mehta,Rupal, AU - Isakova,Tamara, AU - Wolf,Myles, AU - Chertow,Glenn M, Y1 - 2019/07/05/ PY - 2018/10/15/received PY - 2019/05/03/accepted PY - 2019/7/7/pubmed PY - 2020/4/28/medline PY - 2019/7/7/entrez KW - CKD KW - FGF23 KW - RCT KW - anemia KW - ferric citrate KW - hyperphosphatemia SP - 1495 EP - 1504 JF - Journal of the American Society of Nephrology : JASN JO - J Am Soc Nephrol VL - 30 IS - 8 N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. SN - 1533-3450 UR - https://www.unboundmedicine.com/medline/citation/31278194/A_Pilot_Randomized_Trial_of_Ferric_Citrate_Coordination_Complex_for_the_Treatment_of_Advanced_CKD_ L2 - https://jasn.asnjournals.org/cgi/pmidlookup?view=long&amp;pmid=31278194 DB - PRIME DP - Unbound Medicine ER -