Anemia Clinical Trial
Official title:
Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study
Humans have cells in their blood stream called endothelial progenitor cells or EPCs. These
are thought to be important in keeping blood vessels healthy. People with chronic kidney
disease (CKD) have low numbers of these cells. People with cardiovascular (heart and blood
vessel) disease also have low numbers. Patients with CKD have more cardiovascular disease
then any other group.Erythropoietin is a hormone made by the kidneys. It is essential for
making red blood cells and also activates EPCs. It is low in people with kidney disease.
As part of your regular medical care for correcting your low red blood cell count, you will
be receiving a medication that acts like erythropoietin. It is called darbepoetin.
The purpose of this study is to see if darbepoetin treatment affects EPC numbers and
function.
The majority of patients with kidney disease, an estimated 20 million adults in the U.S.,
will die of cardiovascular disease. Further, the risk for cardiovascular events is 2-3 fold
higher than in the general population and increases with the severity of renal impairment
[1]. Reasons for this accelerated atherosclerotic process are unclear. Recent evidence
suggests that endothelial progenitor cells (EPC) are critical to maintaining vascular
integrity [2]. Patient populations with low circulating EPCs, including patients with kidney
disease, have excess vascular disease burden. The hematopoietic cytokine, erythropoietin, is
a key regulator of EPCs and is reduced in patients with kidney disease [3]. Therefore, we
hypothesize that supplementation with the erythropoietin analog, darbepoetin, enhances EPC
function leading to improvement in vascular repair mechanisms in patients with chronic
(CKD).
To begin to explore this hypothesis, we will pursue the following specific aims.
1. Determine the effects of darbepoetin on EPC number in patients with anemia related to
CKD
2. Determine the effects of darbepoetin on EPC function in patients with anemia related to
CKD
3. Determine the effects of darbepoetin on proangiogenic factors in patients with anemia
related to CKD
These studies will expand our understanding and potentially guide therapy aimed at reducing
the excess cardiovascular disease burden in high risk populations.
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