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

Completed · Phase 4

Conditions studied: Chronic Kidney Diseases, Iron Deficiency Anemia

In brief

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).

Key facts

Study ID

NCT03236246

Run by

Keryx Biopharmaceuticals

People needed

206

Starts

2017-08-15

Expected to finish

2019-09-27

Last updated by the study team

2021-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC — Phoenix, Arizona, United States
• California Institute of Renal Research — Chula Vista, California, United States
• California Institute of Renal Research — El Centro, California, United States
• California Institute of Renal Research — Poway, California, United States
• Denver Nephrologists, P.C. — Denver, Colorado, United States
• Miami Kidney Group — Miami, Florida, United States
• Kidney and Hypertension Specialists of Miami, P.A. — Miami, Florida, United States
• Southeastern Clinical Research Institute, LLC — Augusta, Georgia, United States
• Renal Associates, LLC — Columbus, Georgia, United States
• Research by Design, LLC — Chicago, Illinois, United States
• South Mississippi Medical Research, LLC — Gulfport, Mississippi, United States
• Clinical Research Consultants — Kansas City, Missouri, United States
• Sierra Nevada Nephrology Consultants — Reno, Nevada, United States
• Hypertension and Nephrology Association — Eatontown, New Jersey, United States
• Division of Kidney/HTN Research — Great Neck, New York, United States
• Mountain Kidney & Hypertension Associates — Asheville, North Carolina, United States
• Metrolina Nephrology Associates, PA — Charlotte, North Carolina, United States
• Eastern Nephrology Associates — Greenville, North Carolina, United States
• Southeastern Nephrology Associates — Jacksonville, North Carolina, United States
• Eastern Nephrology Associates — New Bern, North Carolina, United States
• Southeastern Nephrology — Wilmington, North Carolina, United States
• Columbia Nephrology Associates, PA — Columbia, South Carolina, United States
• South Carolina Nephrology & Hypertension Center, Inc — Orangeburg, South Carolina, United States
• Nephrology Associates, P.C. — Nashville, Tennessee, United States
• Research Management, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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