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 S
AU - Chertow, Glenn M.
N1 - Funding Information:
Patients were recruited from a large nephrology practice (32 physicians, six Advanced Practitioners, Denver Nephrologists, Denver, CO) from March of 2015 through March of 2017 with the last patient follow-up visit in March of 2018. Active drug (ferric citrate coordination complex, 1-g tablets containing 210 mg ferric iron) was supplied by Keryx Biopharmaceuticals, Inc. The study was funded by Keryx Biopharmaceuticals, Inc.; however, the Principal Investigator (GAB) and coinvestigators were responsible for the design, conduct, and analysis of the study with no input from Keryx Biopharmaceuticals, Inc. The study was approved by the Shulman Institutional Review Board (Cincinnati, OH) and registered at ClinicalTrials.gov (NCT 02492620).
Publisher Copyright:
© 2019 by the American Society of Nephrology.
PY - 2019/8
Y1 - 2019/8
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.
AB - 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.
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U2 - 10.1681/ASN.2018101016
DO - 10.1681/ASN.2018101016
M3 - Article
C2 - 31278194
AN - SCOPUS:85070849119
SN - 1046-6673
VL - 30
SP - 1495
EP - 1504
JO - Journal of the American Society of Nephrology
JF - Journal of the American Society of Nephrology
IS - 8
ER -
