Back to resultsHow Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
Primary Purpose
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
doxercalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Hyperparathyroidism, Secondary
Eligibility Criteria
Inclusion Criteria:
- Stage 5 Chronic Kidney Disease
- Hyperparathyroidism (PTH>300) requiring vitamin D therapy
- Age 18-80 years old
- Ability to provide informed consent
Exclusion Criteria:
- Subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy
- Subjects with contraindications or allergy to vitamin D
- Subjects currently on vitamin D therapy or a history of vitamin D therapy in the previous 60 days
- Serum phosphorus > 6
- Serum calcium > 10.5
- contraindications to nitroglycerin (such as being on sildenafil)
Sites / Locations
- Duke University Medical Center Dialysis Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pre and post doxicalciferol
Arm Description
ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive will receive doxercalciferol 2 mcg or 4 mcg 3 times per week fopr 30 days (1 month). Blood work and vascular laboratory studies will be performed pre and post treatment.
Outcomes
Primary Outcome Measures
Change in Endothelial Cell Function
Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.
Secondary Outcome Measures
Full Information
NCT ID
NCT00528788
First Posted
September 10, 2007
Last Updated
January 20, 2016
Sponsor
Duke University
Collaborators
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00528788
Brief Title
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
Official Title
Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Genzyme, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre and post doxicalciferol
Arm Type
Experimental
Arm Description
ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive will receive doxercalciferol 2 mcg or 4 mcg 3 times per week fopr 30 days (1 month). Blood work and vascular laboratory studies will be performed pre and post treatment.
Intervention Type
Drug
Intervention Name(s)
doxercalciferol
Primary Outcome Measure Information:
Title
Change in Endothelial Cell Function
Description
Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage 5 Chronic Kidney Disease
Hyperparathyroidism (PTH>300) requiring vitamin D therapy
Age 18-80 years old
Ability to provide informed consent
Exclusion Criteria:
Subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy
Subjects with contraindications or allergy to vitamin D
Subjects currently on vitamin D therapy or a history of vitamin D therapy in the previous 60 days
Serum phosphorus > 6
Serum calcium > 10.5
contraindications to nitroglycerin (such as being on sildenafil)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jula Inrig, MD, MHS
Organizational Affiliation
University Texas-Southwestern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynda Szczech, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center Dialysis Unit
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
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