NCT03236246

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Keryx Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Chronic Kidney Diseases
• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	KRX-0502	Oral ferric citrate with meals

Timeline

• Start date: 2017-08-15
• Primary completion: 2019-08-30
• Completion: 2019-09-27
• First posted: 2017-08-01
• Last updated: 2021-03-12
• Results posted: 2021-03-12

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study