Ignite Creation Date:
2025-12-18 @ 8:18 AM
Ignite Modification Date:
2025-12-18 @ 8:18 AM
Study NCT ID:
NCT00396123
Status:
None
Last Update Posted:
2017-06-05 00:00:00
First Post:
2006-11-02 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study
Sponsor:
None
Organization:
Study Overview
Official Title:
Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study
Status:
None
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:
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.
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.
Detailed Description:
None
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?: