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

Keryx Biopharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency Anemia; Chronic Kidney Diseases

Treatments: Drug: KRX-0502

Study type: Interventional

Funder types: Industry

Identifiers

NCT03236246

KRX-0502-402

Details and patient eligibility

About

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).

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Group 1

Experimental group

Description:

KRX-0502 1 tablet thrice daily (TID) with meals

Treatment:

Drug: KRX-0502

Group 2

Experimental group

Description:

KRX-0502 2 tablets twice daily (BID) with the largest 2 daily meals

Treatment:

Drug: KRX-0502