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

• Status: Completed
• Trial end date: 2019-09-27
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keryx Biopharmaceuticals
• Treatments: Citric Acid; Ferric Compounds

Criteria

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