Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D

NCT02492620 | Completed Phase 3

• 1 other identifier: 05D
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Hyperphosphatemia; Iron Deficiency Anemia; Renal Insufficiency

Keywords

ferric citrate; phosphate; kidney

Outcome Measures

Primary Outcomes (1)

• Serum phosphate value prior to starting renal replacement therapy

  baseline

Secondary Outcomes (3)

• Serum hemoglobin prior to starting renal replacement therapy

  baseline

• Serum transferrin saturation prior to starting renal replacement therapy

  baseline

• Serum fibroblast growth factor 23 prior to starting renal replacement therapy

  baseline

Other Outcomes (2)

• Cumulative dose of erythropoietin analog

  Baseline visit to 90 days after starting renal replacement therapy

• Cumulative dose of intravenous iron

  Baseline visit to 90 days after starting renal replacement therapy

Study Arms (2)

Ferric Citrate

ACTIVE COMPARATOR

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.

Drug: Ferric Citrate

Standard of Care (SOC)

NO 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.

Interventions

Ferric Citrate DRUG

Auryxia (ferric citrate) is a non calcium based phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis

Also known as: Auryxia

Ferric Citrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years at screening visit
• Serum phosphate \> or equal to 3.0 mg/dL obtained at screening
• CKD with eGFR \< or equal to 20 mL/min obtained at screening\*
• Hemoglobin (Hgb) \>8.0 g/dL obtained at screening
• TSAT \<55% obtained at screening
• Females of child bearing potential with negative serum pregnancy test obtained at screening
• Willing and able to give written informed consent
• Anticipated to have \> or equal to 8 weeks prior to need for initiating RRT in the opinion of the investigator

You may not qualify if:

• Liver enzymes (ALT/AST) \>X3 times upper limit of normal at screening
• Use of IV iron, blood transfusions or ESA agents within 2 weeks prior to the screening visit and prior to the Day 1 visit.
• Evidence of acute kidney injury (i.e., no CKD) or planned need for RRT within 12 weeks of screening
• Scheduled kidney transplant within 24 weeks of screening
• Contra-indication to ferric citrate: iron overload syndrome, allergic reaction or known intolerance to ferric citrate
• Clinically significant medical condition felt to interfere with tolerance of oral medication
• Life expectancy \< 6 months or confirmed conviction that subject does NOT want to initiate RRT despite a decline in kidney function
• Active drug or alcohol dependence or abuse (excluding tobacco use or marijuana use) within the 12 months prior to screening (in the opinion of the PI)
• Psychiatric disorder that interferes with the subject's ability to comply with the study protocol in the opinion of the PI
• Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
• Inability to cooperate with study personnel or study procedures
• Females who are pregnant or breastfeeding
• Receiving or has received any investigational drug with in the past 30 days prior to the Day 1 visit

Sponsors & Collaborators

• Denver Nephrologists, P.C.: lead
• Keryx Biopharmaceuticals: collaborator

Study Sites (1)

Denver Nephrologists, P.C.

Denver, Colorado, 80230, United States

Location

Related Publications (1)

• 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: 40576086 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia; Anemia, Iron-Deficiency; Renal Insufficiency

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders

Study Officials

• Geoffrey A Block, MD

  Denver Nephrologists, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 8, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

US (1)