Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis
A Phase 2 Study of KRX-0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects With Stage III to V Chronic Kidney Disease Not on Dialysis
1 other identifier
interventional
149
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2012
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 16, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
October 20, 2017
CompletedOctober 20, 2017
September 1, 2017
1 year
November 16, 2012
August 17, 2017
September 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment
The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.
12 Weeks
Change in Serum Phosphorus Levels From Baseline to End of Treatment
The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.
12 Weeks
Secondary Outcomes (2)
Change in Ferritin Levels From Baseline to End of Treatment
12 Weeks
Change in Hemoglobin Levels From Baseline to End of Treatment
12 Weeks
Study Arms (2)
Ferric Citrate
EXPERIMENTALFerric 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.
Placebo
PLACEBO COMPARATORPlacebo 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.
Interventions
Dose depends on serum phosphorus levels collected at each study visit.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Tempe, Arizona, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Edgewater, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Meridian, Idaho, United States
Unknown Facility
Evergreen Park, Illinois, United States
Unknown Facility
Bethesda, Maryland, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Pontiac, Michigan, United States
Unknown Facility
Reno, Nevada, United States
Unknown Facility
Great Neck, New York, United States
Unknown Facility
Mineola, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Wilmington, North Carolina, United States
Unknown Facility
Orangeburg, South Carolina, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Related Publications (2)
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.
PMID: 40576086DERIVEDBlock 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.
PMID: 25468387DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keryx Medical Information
- Organization
- Keryx Biopharmaceuticals
Study Officials
- STUDY CHAIR
Geoffrey Block, MD
- STUDY CHAIR
Glenn Chertow, MD
- STUDY CHAIR
Steven Fishbane, MD
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2012
First Posted
November 29, 2012
Study Start
November 1, 2012
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
October 20, 2017
Results First Posted
October 20, 2017
Record last verified: 2017-09