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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00396123
First received: November 2, 2006
Last updated: April 15, 2011
Last verified: April 2011
History of Changes
  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: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:
Estimated Enrollment: 15
Study Start Date: November 2006
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, MD, Internal Medicine, University of Michigan Medical School
ClinicalTrials.gov Identifier: NCT00396123     History of Changes
Other Study ID Numbers: HUM 7825 
Study First Received: November 2, 2006
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Chronic Kidney Disease
Anemia

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 26, 2016