Chronic Kidney Disease Clinical Trial
Official title:
A Randomized Study on the Effects of Sevelamer Carbonate Versus Calcium Acetate on Biomarkers of Vascular Calcification, Inflammation, and Endothelial Dysfunction in Chronic Kidney Disease Stages 3 and 4
Chronic kidney disease (CKD) patients often have high levels of a substance called
fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related
to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and
as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels,
more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine.
In addition to effects on FGF-23, increased phosphorus levels can lead to calcification
(hardening) of the blood vessels in the CKD population.
Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus
absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD,
studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering
FGF-23 levels in CKD patients may also lower substances in the blood that cause
calcification of blood vessels in the CKD population.
This study is being done to determine if using phosphate binders, either sevelamer carbonate
or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease
FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood
vessels and heart disease.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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