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| Sponsored by: |
University of Michigan |
|---|---|
| Information provided by: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00396123 |
Purpose
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.
| Condition |
|---|
|
Chronic Kidney Disease Anemia |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Convenience Sample, Prospective Study |
| Official Title: | Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study |
| Estimated Enrollment: | 15 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | October 2007 |
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.
These studies will expand our understanding and potentially guide therapy aimed at reducing the excess cardiovascular disease burden in high risk populations.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Are currently receiving:
Have had problems within the last 3 months with:
Contacts and Locations| Contact: Rosemarie Shim, MD | 734-615-3994 | rshim@umich.edu |
| Contact: Kathryn M Lindblad, RN, MS | 734-764-5187 | lindblad@umich.edu |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Kathryn M Lindblad, RN, MS 734-764-5187 lindblad@umich.edu | |
| Principal Investigator: Crystal A Gadegbeku, MD | |
| Sub-Investigator: Rosemarie Shim, MD | |
| Sub-Investigator: Rachel L Perlman, MD | |
| Sub-Investigator: Mariana Kaplan, MD | |
| Principal Investigator: | Crystal A Gadegbeku, MD | University of Michigan/Internal Medicine/Nephrology |
More Information
| Study ID Numbers: | HUM 7825 |
| Study First Received: | November 2, 2006 |
| Last Updated: | November 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00396123 |
| Health Authority: | United States: Institutional Review Board |
|
Chronic Kidney Disease Anemia |
|
Renal Insufficiency Urologic Diseases Hematologic Diseases Renal Insufficiency, Chronic |
Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |
