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.

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Key information

Conditions

Chronic Kidney Disease Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Determine the effects of darbepoetin on EPC number in patients with anemia related to CKD
Determine the effects of darbepoetin on EPC function in patients with anemia related to CKD
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Enrolled in University of Michigan's Nephrology Anemia Clinic
18 years old or older
Have kidney disease but are not on dialysis

Exclusion criteria

Not enrolled in University of Michigan's Nephrology Anemia Clinic
Less than 18 years of age
Hematocrit that is less than 28.5%
Currently participating in a clinical trial with an intervention
Planning to change their tobacco use habits during the study period
Have had dose changes of certain medications for cholesterol or diabetes within one month of study enrollment
Are currently receiving:

darbepoetin
erythopoietin
medications to lower your immune system
Have had problems within the last 3 months with:

Bleeding
Heart attack or stroke
Heart or blood vessel procedures
Are pregnant or lactating

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Nov 6, 2006
Registry last updated: Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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