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

NCT00396123 | Completed

• 1 other identifier: HUM 7825
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Anemia

Keywords

Chronic Kidney Disease; Anemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nephrology clinic

You may qualify if:

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

You may not qualify if:

• 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 & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Crystal A Gadegbeku, MD

  University of Michigan/Internal Medicine/Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine, Nephrology

Study Record Dates

• First Submitted: November 2, 2006
• First Posted: November 6, 2006
• Study Start: November 1, 2006
• Primary Completion: July 25, 2008
• Study Completion: July 25, 2008
• Last Updated: June 5, 2017

Record last verified: 2017-06

Locations

US (1)