Iron Deficiency and FGF23 Regulation in CKD and HF
Completed
Conditions studied: Chronic Kidney Diseases, Chronic Heart Failure, Iron Deficiency Anemia
In brief
This study investigates the effects of intravenous (IV) iron sucrose therapy on blood levels of Fibroblast Growth Factor 23 (FGF23, a protein that regulates the amount of phosphate in the body) in iron deficiency anemia in healthy participants, participants with Congestive Heart Failure (CHF, where the heart does not pump adequate blood supply to the body), participants with Chronic Kidney Disease (CKD, where the kidney function is reduced), and participants with CKD and CHF.
Key facts
- Study ID
- NCT03106298
- Run by
- Northwestern University
- People needed
- 77
- Starts
- 2015-12-18
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2019-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥ 18 years old
- Ability to understand and the willingness to sign a written informed consent.
- Iron Deficiency Anemia, as defined by
- Ferritin level < 100 ng/ml or
- Transferrin saturation <20% with ferritin 100-350 ng/ml and
- Hemoglobin < 12 g/dl
You may not qualify if…
- Hypersensitivity to any component of iron sucrose
- Malignancy within 5 years
- End stage renal disease or kidney transplantation
- Erythropoiesis stimulating agents
- Red blood cell transfusions within last 60 days
- Current radiotherapy or chemotherapy
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 1.5 times normal
- Hemochromatosis
- Chronic digestive diseases
- Pregnancy or nursing
- Active alcohol or drug abuse
- Uncontrolled hypertension
- Active infection
- Hospitalization in the 4 preceding weeks
- Concomitant use of antibiotics
- Concomitant use of immunosuppression
- Inability to consent.
- Conditions, in which of the opinion of the investigator, make participation unacceptable
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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