Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396123
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2006-11-02
Brief Title:
Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 groupErythropoietin 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
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
Detailed Description:
The majority of patients with kidney disease an estimated 20 million adults in the US 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None