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Ferric citrate complex can increase hemoglobin, reduce serum phosphate in advanced CKD
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Ferric citrate complex can help increase hemoglobin and reduce serum phosphate in patients with advanced chronic kidney disease, a recently published study shows.
“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 [CKD] population,” Geoffrey A. Block, MD, and colleagues wrote. The authors wanted to determine “whether fixed-dose ferric citrate coordination complex favorably affects multiple biochemical parameters in patients with advanced CKD.”
Past randomized clinical trials testing the effects of erythropoiesis-stimulating agents (ESAs) targeting a normal or near-normal hemoglobin concentration have shown use of ESAs for that purpose led to higher rates of stroke, venous thromboembolic disease, and vascular access thrombosis.
“However, there remains clinical equipoise as to whether anemia, per se, increases CV risk and reduces quality of life; it has been suggested that the risk observed in clinical trials using ESAs to normalize hemoglobin may be related to adverse drug effects, possibly related to excessive dosing of ESAs in treatment-resistant patients, rather than to the correction of anemia itself,” the authors wrote.
To test that theory, “We hypothesized that treatment with ferric citrate coordination complex (FCCC) would favorably affect patients with [advanced] aCKD irrespective of whether iron deficiency or overt hyperphosphatemia were present,” the authors wrote.
Patients were recruited from a large nephrology practice from March 2015 through March 2017 with the last patient follow-up visit in March 2018. Researchers randomly assigned 203 patients from the practice with eGFRs less than or equal to 20 ml/min per 1.73 m2 (2:1 ratio) to receive a fixed dose of FCCC. The dose was two tablets per meal, amounting to 210-mg ferric iron per tablet. The second group of patients received usual care for 9 months or until 3 months after starting dialysis.
FCCC “significantly increased hemoglobin, transferrin saturation, and serum ferritin, and it significantly reduced serum phosphate and intact FGF23 (P<.001 for all),” the researchers wrote.
Dialysis was started in 23% of the patients randomized to FCCC, while 48% patients randomized to usual care started dialysis during the study. The FCCC treatment also resulted in significantly fewer annualized hospital admissions along with fewer days in the hospital. A lower incidence of the composite end point of death, provision of dialysis or transplantation was also noted.
“ ... 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,” the authors wrote. –by Mark E. Neumann
Disclosures: The study was funded by Keryx Biopharmaceuticals. Block reports grants from Keryx during the conduct of the study, along with other pharmaceutical companies. Please see the study for all other authors’ relevant financial disclosures.
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