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A Pilot Randomized Trial of Ferric Citrate Coordination Complex for the Treatment of Advanced CKD
Geoffrey A Block1, Martha S Block2, Gerard Smits3
1Reata Pharmaceuticals, Dallas, Texas; geoff@goldenblocks.org.
Insights
Fixed-dose ferric citrate coordination complex improved anemia and mineral metabolism in advanced CKD patients. This treatment also reduced dialysis initiation, hospitalizations, and adverse events, showing a promising safety profile.
Area of Science:
- Nephrology
- Internal Medicine
- Biochemistry
Background:
- Optimal care for advanced chronic kidney disease (CKD) remains undetermined.
- Anemia and disordered mineral metabolism, including phosphate and fibroblast growth factor 23 (FGF23) abnormalities, are linked to poor outcomes in advanced CKD.
- Current treatment strategies for advanced CKD require further optimization.
Purpose of the Study:
- To evaluate the efficacy of a fixed-dose ferric citrate coordination complex in managing biochemical parameters in advanced CKD patients.
- To assess the impact of ferric citrate coordination complex on anemia, mineral metabolism, and clinical outcomes in advanced CKD.
- To determine the safety profile of ferric citrate coordination complex in an unselected advanced CKD population.
Main Methods:
- A randomized controlled trial involving 203 patients with advanced CKD (eGFR ≤20 ml/min per 1.73 m²).
- Patients were assigned 2:1 to receive either a fixed dose of ferric citrate coordination complex or usual care for 9 months.
- Outcomes included changes in hemoglobin, transferrin saturation, ferritin, phosphate, FGF23, dialysis initiation, and hospitalization rates.
Main Results:
- Ferric citrate coordination complex significantly improved hemoglobin, transferrin saturation, and ferritin levels.
- Treatment with ferric citrate coordination complex led to significant reductions in serum phosphate and intact FGF23.
- Patients receiving ferric citrate coordination complex had significantly lower rates of dialysis initiation, hospital admissions, and a composite endpoint of death, dialysis, or transplantation compared to usual care.
Conclusions:
- Fixed-dose ferric citrate coordination complex demonstrates beneficial effects on key biochemical markers in advanced CKD.
- The treatment shows a favorable impact on clinical outcomes, including reduced hospitalization and dialysis initiation.
- Ferric citrate coordination complex exhibits an excellent safety profile in advanced CKD patients and warrants further investigation.
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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