A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia

Inclusion Criteria: * Males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at Screening * Age ≥ 18 years * Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening * Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening * eGFR \<60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation Exclusion Criteria: * Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening * Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or Crohn's Disease within 24 weeks prior to \\ Screening * Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to Screening * Kidney transplant anticipated or start of dialysis expected within 16 weeks of Screening * History of hemochromatosis * IV iron administered within 4 weeks prior to Screening * Erythropoiesis-Stimulating Agent (ESA) administered within 4 weeks prior to Screening * Blood transfusion within 4 weeks prior to Screening * Receipt of any investigational drug within 4 weeks prior to Screening * Cause of anemia other than iron deficiency or chronic kidney disease * History of malignancy in the last five years * Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to Screening * Any known allergies to iron products * Previous intolerance to oral ferric citrate * Psychiatric disorder that interferes with the sub…