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Iron-Based Phosphate Binder

Ferric Citrate for Iron-Deficiency Anemia (05D Trial)

Phase 3
Waitlist Available
Led By Geoffrey A Block, MD
Research Sponsored by Denver Nephrologists, P.C.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit to 90 days after starting renal replacement therapy
Awards & highlights

Summary

It is the investigators hypothesis that participants treated with Ferric Citrate (FC) during the non-dialysis CKD stage (4/5) with sufficient duration prior to initiating RRT, will result in improved biochemical control of anemia (Hb, TSAT) and mineral metabolism (P, FGF23) and furthermore, will result in a reduced need for ESA and intravenous iron. The investigators further hypothesize that effective treatment of anemia and mineral metabolism with FC in the pre-dialysis and transition period will result in improved physical functioning, reduced hospitalization and reduced total cost of care when compared to participants receiving contemporaneously provided standard of care therapy.

Eligible Conditions
  • Iron-Deficiency Anemia
  • Kidney Failure
  • Chronic Kidney Disease
  • High Phosphate Levels

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit to 90 days after starting renal replacement therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit to 90 days after starting renal replacement therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Cumulative dose of erythropoietin analog
Cumulative dose of intravenous iron

Trial Design

2Treatment groups
Active Control
Group I: Ferric CitrateActive Control1 Intervention
Ferric citrate (FC) will be supplied as tablets containing 210mg of ferric iron (as 1g ferric citrate) to those subjects randomized to FC. These participants will be initiated on study drug with a fixed dose of FC beginning with 2 tablet per meal.
Group II: Standard of Care (SOC)Active Control1 Intervention
Participants may receive open-label, non-FC phosphate binders at the discretion of their treating physician. During the Dialysis Period, dose of phosphate binders, use of ESA, intravenous iron and blood transfusions will be at the discretion of the primary treating nephrologist. Participants assigned to the SOC treatment arm may not receive FC at any point during the study.

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Who is running the clinical trial?

Denver Nephrologists, P.C.Lead Sponsor
6 Previous Clinical Trials
589 Total Patients Enrolled
Keryx BiopharmaceuticalsIndustry Sponsor
20 Previous Clinical Trials
3,959 Total Patients Enrolled
Geoffrey A Block, MDPrincipal InvestigatorDenver Nephrologists, P.C.
7 Previous Clinical Trials
599 Total Patients Enrolled
~19 spots leftby Oct 2025
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