Chronic Kidney DiseaseNCT00396123
Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study
An observational study of Chronic Kidney Disease and Anemia, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Anemia
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to 25 Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Nephrology clinic
Who may be able to join
- Enrolled in University of Michigan's Nephrology Anemia Clinic
- 18 years old or older
- Have kidney disease but are not on dialysis
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Anemia
- Keywords
- Chronic Kidney Disease, Anemia
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startNov 2006
- Primary completion25 Jul 2008
- Study completion25 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal A. Gadegbeku, University of Michigan
- Investigators
- Crystal A Gadegbeku, MD, Principal investigator, University of Michigan/Internal Medicine/Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396123
- Sponsor's protocol ID
- HUM 7825
- Status last verified
- Jun 2017
- First submitted
- 2 Nov 2006
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Darbepoetin On Vascular Repair Mechanisms In Kidney Disease The DARBEPC Study
- ClinicalTrials.gov ID
- NCT00396123
- Acronym / sponsor ID
- HUM 7825
- Conditions
- Chronic Kidney Disease, Anemia
- Keywords
- Chronic Kidney Disease, Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- 25 Jul 2008 (actual)
- Study completion
- 25 Jul 2008 (actual)
- First posted
- 6 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nephrology clinic
Key inclusion criteria (3 listed)
- Enrolled in University of Michigan's Nephrology Anemia Clinic
- 18 years old or older
- Have kidney disease but are not on dialysis
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal A Gadegbeku, MD principal investigator
University of Michigan/Internal Medicine/Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Anemia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.