Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00396123

Recruitment Status : Completed

First Posted : November 6, 2006

Last Update Posted : June 5, 2017

Sponsor:

Information provided by (Responsible Party):

Crystal A. Gadegbeku, University of Michigan

Study Description

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 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 or disease
Chronic Kidney Disease Anemia

Detailed Description:

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.

Study Design


Study Type :	Observational
Actual Enrollment :	12 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study
Study Start Date :	November 2006
Actual Primary Completion Date :	July 25, 2008
Actual Study Completion Date :	July 25, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Darbepoetin Alfa

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Nephrology clinic

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396123

Locations


United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators


Principal Investigator:	Crystal A Gadegbeku, MD	University of Michigan/Internal Medicine/Nephrology

More Information


Responsible Party:	Crystal A. Gadegbeku, Associate Professor of Internal Medicine, Nephrology, University of Michigan
ClinicalTrials.gov Identifier:	NCT00396123 History of Changes
Other Study ID Numbers:	HUM 7825
First Posted:	November 6, 2006 Key Record Dates
Last Update Posted:	June 5, 2017
Last Verified:	June 2017

Keywords provided by Crystal A. Gadegbeku, University of Michigan:


Chronic Kidney Disease Anemia

Additional relevant MeSH terms:


Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases	Renal Insufficiency Darbepoetin alfa Hematinics

To Top