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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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