Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
NCT ID: NCT01736397
Last Updated: 2017-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
149 participants
INTERVENTIONAL
2012-11-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ferric Citrate
Ferric citrate will be taken with or within one hour of meals or snacks. The starting dose of ferric citrate is 3 tablets/day and titrated by the subject's serum phosphorus results at each treatment visit.
Ferric Citrate
Dose depends on serum phosphorus levels collected at each study visit.
Placebo
Placebo will be taken with or within one hour of meals or snacks. The starting dose of placebo is 3 tablets per day and titrated by the subject's serum phosphorus results at each treatment visit.
Placebo
Interventions
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Ferric Citrate
Dose depends on serum phosphorus levels collected at each study visit.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Keryx Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Geoffrey Block, MD
Role: STUDY_CHAIR
Glenn Chertow, MD
Role: STUDY_CHAIR
Steven Fishbane, MD
Role: STUDY_CHAIR
Locations
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Tempe, Arizona, United States
La Mesa, California, United States
Sacramento, California, United States
Denver, Colorado, United States
Edgewater, Florida, United States
Miami, Florida, United States
Meridian, Idaho, United States
Evergreen Park, Illinois, United States
Bethesda, Maryland, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Pontiac, Michigan, United States
Reno, Nevada, United States
Great Neck, New York, United States
Mineola, New York, United States
Asheville, North Carolina, United States
Wilmington, North Carolina, United States
Orangeburg, South Carolina, United States
Houston, Texas, United States
San Antonio, Texas, United States
Countries
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References
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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Block GA, Fishbane S, Rodriguez M, Smits G, Shemesh S, Pergola PE, Wolf M, Chertow GM. A 12-week, double-blind, placebo-controlled trial of ferric citrate for the treatment of iron deficiency anemia and reduction of serum phosphate in patients with CKD Stages 3-5. Am J Kidney Dis. 2015 May;65(5):728-36. doi: 10.1053/j.ajkd.2014.10.014. Epub 2014 Nov 4.
Other Identifiers
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KRX-0502-204
Identifier Type: -
Identifier Source: org_study_id