Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
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ClinicalTrials.gov Identifier: NCT02888171 |
Recruitment Status :
Completed
First Posted : September 2, 2016
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease Iron Deficiency Anemia | Drug: ferric citrate Drug: ferrous sulfate | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With Moderate to Severe Chronic Kidney Disease (CKD) With Iron Deficiency |
Actual Study Start Date : | September 2016 |
Actual Primary Completion Date : | February 12, 2019 |
Actual Study Completion Date : | March 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: ferric citrate
Participants randomized to the ferric citrate arm will receive 2 grams of ferric citrate three times a day with each meal.
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Drug: ferric citrate
Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
Other Name: Auryxia |
Active Comparator: ferrous sulfate
Participants randomized to the ferrous sulfate arm will receive 325 mg of ferrous sulfate three times a day
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Drug: ferrous sulfate
Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day. |
- Change in Ferritin From Baseline to End of Treatment [ Time Frame: Baseline and 12 weeks ]The change in serum ferritin concentrations from the baseline of the study to the 12 week time point.
- Change in Transferrin Saturation From Baseline to End of Treatment [ Time Frame: Baseline and 12 weeks ]The change in serum transferrin saturation from the baseline to the end of treatment
- Change in Hemoglobin From Baseline to End of Treatment [ Time Frame: Baseline and 12 weeks ]The change in hemoglobin concentrations from the baseline visit to the 12-week time point.
- Change in Hepcidin From Baseline to the End of Treatment [ Time Frame: Baseline and 12 weeks ]The change in hepcidin concentrations from the baseline visit to the 12-week time point.
- Change in Fibroblast Growth Factor 23 From Baseline to the End of Treatment [ Time Frame: Baseline and 12 weeks ]The change in fibroblast growth factor 23 concentrations from the baseline visit to the 12-week time point.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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%)
Exclusion Criteria:
- 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.
- Current use of an active vitamin D analog

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888171
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Orlando M Gutierrez, MD | University of Alabama at Birmingham |
Documents provided by Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham:
Responsible Party: | Orlando M. Gutierrez, MD, MMSc, Associate Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT02888171 |
Other Study ID Numbers: |
F160318006 |
First Posted: | September 2, 2016 Key Record Dates |
Results First Posted: | March 24, 2020 |
Last Update Posted: | March 24, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Kidney Diseases Renal Insufficiency, Chronic Anemia, Iron-Deficiency Urologic Diseases Renal Insufficiency |
Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases |