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

Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia

The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).

This is a Phase 4, 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