Table 4.

Participant inclusion and exclusion criteria

Inclusion criteria

Ages 6 to 17 years (inclusive)

Estimated glomerular filtration rate of 15–59 ml/min/1.73 m2 by the updated CKiD formula [60]

Serum phosphate within age-appropriate normal ranges

Serum ferritin < 500 ng/ml and transferrin saturation < 50%

For those patients treated with nutritional vitamin D, calcitriol, iron, and/or erythropoiesis-stimulating agents, doses must be stable for at least 2 weeks prior to screening

Able to swallow tablets

Able to eat at least two meals a day

In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator’s recommendations

Exclusion criteria

Current treatment with phosphate binders

History of allergic reactions, defined as rashes or hives, to ferric citrate or iron preparations

Current intestinal malabsorption, documented in the medical record

Anticipated initiation of dialysis or kidney transplantation within 6 months

Current or planned future systemic immunosuppressive therapy

Prior solid organ transplantation

Receipt of bone marrow transplant within 2 years of screening

Current pregnancy, current lactation, or female subjects who have reached puberty, unless using highly effective contraception

Patients participating in other interventional study (observational study participation is permitted)

Poor adherence to medical treatments in the opinion of the investigator