An observational study in Chronic Kidney Diseases, Chronic Heart Failure and Iron Deficiency Anemia, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by Northwestern University · Observational
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.
Iron is a key part of our red blood cells which bring oxygen to our body's tissues. Without iron, our blood cannot carry oxygen. The body normally gets iron through diet and it also re-uses iron from old red blood cells. When iron stores are low, patients get iron deficiency anemia. This can happen because patients lose more red blood cells and iron than the body can replace, the body does not do a good job at absorbing iron from the diet, or the body is able to absorb iron but patients are not getting enough iron from their diets. Many patients with chronic diseases such as CKD and CHF also have iron deficiency anemia.
Iron deficiency may also cause a hormone in the body named FGF23 to rise. FGF23 is a hormone that is made in bone and has an important role in the heart and kidney. When the kidneys are not working properly, as in CKD, or when the heart is not pumping correctly, as in CHF, FGF23 levels in the blood go up. Many patients with CKD or CHF also have low levels of iron. In these cases, FGF23 levels may rise even more. Too much FGF23 in the blood may lead to an increased risk of heart problems and accelerate loss of kidney function. The best way to control FGF23 levels in the blood in CKD and CHF is not known.
The investigators are conducting a 6-week iron deficiency anemia study on healthy individuals,individuals with CKD, and individuals with CHF to find out if treating iron deficiency anemia with intravenous iron sucrose therapy can safely and successfully lower FGF23 levels. Iron sucrose has been shown to lower FGF23 in animal models. The short term effects of iron sucrose on FGF23 levels in CKD and CHF are not known.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 77 is below the median of 200 across 889 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Northwestern University is the lead sponsor of 1,420 studies on the registry; 199 are open to participants now.
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All patients with iron deficiency anemia will be enrolled (those without CKD or HF, those with CKD only, those with HF only, and those with CKD/HF). They will be given iron sucrose as routine care for treatment of their iron deficiency anemia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients with iron deficiency anemia (those without CKD or HF, those with CKD only, those with HF only, and those with CKD/HF) will be given 5 weekly doses of 200 mg of intravenous iron sucrose.
Drug: Iron Sucrose
All participants will be given intravenous iron sucrose (200 mg) weekly for 5 weeks. Iron sucrose is infused over 60 minutes.
Also known as: Venofer
Change in c-terminal FGF23 measurements
longitudinal change in plasma c-terminal FGF23 (RU/ml) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Intact FGF23 measurements
longitudinal change in plasma intact FGF23 (pg/ml) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Parathyroid Hormone
longitudinal change in Serum Parathyroid Hormone (pg/ml) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Phosphate (mg/dl)
longitudinal change in Plasma Phosphate (mg/dl) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Serum creatinine
longitudinal change in Serum creatinine (mg/dl) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in 1,25 dihydroxyvitamin D
longitudinal change in 1,25 dihydroxyvitamin D (pg/ml) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in C-reactive protein
longitudinal change in C-reactive protein (mg/L) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Ferritin Measurement
longitudinal change in serum ferritin (ng/ml) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Iron Measurement
longitudinal change in Serum iron (ug/dl) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Transferrin Saturation
longitudinal change in Transferrin Saturation (%) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Change in Hemoglobin Measurement
longitudinal change in Serum hemoglobin (g/dl) over 6 weeks and 3 months
Time frame: Weekly x 6 weeks, 1 longitudinal measurement at 3 months
Plan to share: No — Individual participant data will not be shared with other researchers
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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