N/A
Completed N=60
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
Source: ClinicalTrials.gov NCT02888171 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Change in Ferritin From Baseline to End of Treatment — 60; 30 percentage of change from baseline
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Ferritin From Baseline to End of Treatment |
60; 30 | — |
| PRIMARY Change in Transferrin Saturation From Baseline to End of Treatment |
40; 2 | — |
| SECONDARY Change in Hemoglobin From Baseline to End of Treatment |
4; 0 | — |
| SECONDARY Change in Hepcidin From Baseline to the End of Treatment |
98; 28 | — |
| SECONDARY Change in Fibroblast Growth Factor 23 From Baseline to the End of Treatment |
-37; -8 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02888171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.