Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial.
Rebecca Womack, Fabian Berru, Bhupesh Panwar...
https://pubmed.ncbi.nlm.nih.gov/32694162Completed
Phase Not Applicable
Age: 18Years +
All Genders
ID02888171
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
Led by University of Alabama at Birmingham · Updated on 2020-03-24
60
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here