Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis

Launched by KERYX BIOPHARMACEUTICALS · Nov 26, 2012

Keywords

ClinConnect Summary

This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Stage III to V Chronic Kidney Disease
• • Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
• • Ferritin 300 ng/mL or less
• • Transferrin Saturation (TSAT) 30% or less
• • Hemoglobin \>9.0 and \<12.0 g/dL
• • Must consume a minimum of 2 meals per day
• Exclusion Criteria:
• • Parathyroidectomy within 24 weeks of study
• • gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
• • Requirement for dialysis or kidney injury within 8 weeks of study
• • Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
• • Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
• • Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
• • History of hemochromatosis
• • Allergy to iron products
• • History of malignancy in last 5 years