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

Completed · Phase 2 · Has a placebo group

Conditions studied: Iron Deficiency, Iron Deficiency Anemia

In brief

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.

Key facts

Study ID

NCT01736397

Run by

Keryx Biopharmaceuticals

People needed

149

Starts

2012-11-01

Expected to finish

2013-12-01

Last updated by the study team

2017-10-20

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tempe, Arizona, United States
• Study site — La Mesa, California, United States
• Study site — Sacramento, California, United States
• Study site — Denver, Colorado, United States
• Study site — Edgewater, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Meridian, Idaho, United States
• Study site — Evergreen Park, Illinois, United States
• Study site — Bethesda, Maryland, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Pontiac, Michigan, United States
• Study site — Reno, Nevada, United States
• Study site — Great Neck, New York, United States
• Study site — Mineola, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Orangeburg, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.