Status:
UNKNOWN
Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
Lead Sponsor:
Scott and White Hospital & Clinic
Collaborating Sponsors:
Abbott
Conditions:
Type 2 Diabetes
Chronic Kidney Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this research study is to study the effects of paricalcitol on endothelial function and inflammation, cardiovascular risk factors which are associated with patient populations that have...
Eligibility Criteria
Inclusion
- Patients with Type 2 diabetes and CKD
- Age 18 - 70 years
- Stable anti-hypertensive and lipid lowering therapy for at least 2 months. All patients should be on an ACEI or ARB unless contraindicated because of side effects (standard of care). No changes in lipid lowering therapy during the 3 months of this study. Blood pressure doses may be changed but new therapy with ACE inhibitors will not be allowed.
Exclusion
- Severe co morbid conditions - e.g. Cancer, etc.
- Congestive heart failure.
- Inability to give informed consent or attend study related visits.
- Have a history of abnormally high vitamin D or calcium levels in the bloodstream.
- Unwilling or unable to complete screening or data collection procedures.
- Have a known allergy to the study drug.
- Pregnant or breast feeding
- Plasma Calcium \>9 mg/dl
- Patients should discontinue any calcium supplementation prior to entry into the study.
- Other vitamin D analogs (eg Sensipar) and vitamin D preparations are contraindicated
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01792206
Start Date
September 1 2009
End Date
February 1 2013
Last Update
February 15 2013
Active Locations (4)
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1
Emory University
Atlanta, Georgia, United States, 30303
2
Tulane University
New Orleans, Louisiana, United States, 70112
3
Joslin Diabetes Clinic, Inc.
Boston, Massachusetts, United States, 02215
4
Omaha VA Medical Center
Omaha, Nebraska, United States, 68105