Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency

NCT02888171 | Completed Results

• 1 other identifier: F160318006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the study is to compare the impact of oral ferric citrate compared to standard of care oral ferrous sulfate on serum iron, percent transferrin saturation, ferritin, hepcidin and hemoglobin levels in individuals with moderate to severe chronic kidney disease (CKD) and absolute iron deficiency.

Conditions

Chronic Kidney Disease; Iron Deficiency; Anemia

Outcome Measures

Primary Outcomes (2)

• Change in Ferritin From Baseline to End of Treatment

  The change in serum ferritin concentrations from the baseline of the study to the 12 week time point.

  Baseline and 12 weeks

• Change in Transferrin Saturation From Baseline to End of Treatment

  The change in serum transferrin saturation from the baseline to the end of treatment

  Baseline and 12 weeks

Secondary Outcomes (3)

• Change in Hemoglobin From Baseline to End of Treatment

  Baseline and 12 weeks

• Change in Hepcidin From Baseline to the End of Treatment

  Baseline and 12 weeks

• Change in Fibroblast Growth Factor 23 From Baseline to the End of Treatment

  Baseline and 12 weeks

Study Arms (2)

ferric citrate

EXPERIMENTAL

Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.

Drug: ferric citrate

ferrous sulfate

ACTIVE COMPARATOR

Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day

Drug: ferrous sulfate

Interventions

ferric citrate DRUG

Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.

Also known as: Auryxia

ferric citrate

ferrous sulfate DRUG

Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.

ferrous sulfate

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 or greater
• Moderate to severe CKD not requiring dialysis (eGFR 15 - 45 ml/min/1.73 m2 by CKD-EPI)
• Absolute iron deficiency (serum ferritin \<300ng/ml and Transferrin Saturation \< 30%)

You may not qualify if:

• Hemoglobin concentrations \> 13 g/dL
• Known disorder of iron homeostasis (e.g., hemochromatosis)
• Known gastrointestinal disorder (irritable bowel disease, inflammatory bowel disease)
• Known liver disease (ALT/AST or bilirubin \> 3x normal)
• Serum phosphorus concentrations \< 3.0 mg/dL
• Any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia)
• Symptomatic gastrointestinal bleeding within 12 weeks prior to the screening visit.
• Subjects receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or renal transplant.
• Pregnancy or lactation in female participants
• Severe anemia defined as a hemoglobin \< 8.0 g/dL for males or a hemoglobin \<7.0 g/dL for females.
• Receipt of erythropoiesis stimulating agents within 4 weeks of screening.
• Receipt of intravenous iron therapy within 8 weeks of screening.
• Blood transfusion within 4 weeks of screening
• Known allergies or severe adverse reactions to previous oral iron therapy
• Current use of oral phosphorus binders.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Womack R, Berru F, Panwar B, Gutierrez OM. Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial. Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1251-1258. doi: 10.2215/CJN.15291219. Epub 2020 Jul 21.

  PMID: 32694162 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Iron Deficiencies; Anemia

Interventions

ferric citrate; ferrous sulfate

Condition Hierarchy (Ancestors)

Renal Insufficiency; 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; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Orlando M. Gutierrez, MD
• Organization: University of Alabama at Birmingham

ogutierrez@uabmc.edu

205-996-2736

Study Officials

• Orlando M Gutierrez, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 2, 2016
• Study Start: September 1, 2016
• Primary Completion: February 12, 2019
• Study Completion: March 30, 2019
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)