KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)

This is a 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods:
a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study
will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as
needed.

Inclusion Criteria:

- Estimated glomerular filtration rate ≥20 mL/min and <60 mL/min

- Hgb ≥8.5 g/dL and ≤11.5 g/dL

- Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%

- Serum intact parathyroid hormone ≤600 pg/mL

Exclusion Criteria:

- Serum phosphate <3.0 mg/dL

- Intravenous (IV) iron administered within 4 weeks prior to Screening

- Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening

- Blood transfusion within 4 weeks prior to Screening