How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
Completed · Phase 4
Conditions studied: Hyperparathyroidism, Secondary, Kidney Failure, Chronic
In brief
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.
Key facts
- Study ID
- NCT00528788
- Run by
- Duke University
- People needed
- 24
- Starts
- 2007-09-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2016-01-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Stage 5 Chronic Kidney Disease
- Hyperparathyroidism (PTH>300) requiring vitamin D therapy
- Age 18-80 years old
- Ability to provide informed consent
You may not qualify if…
- 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)
Where it is running
- Duke University Medical Center Dialysis Unit — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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