Overview

How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
Genzyme, a Sanofi Company
Treatments:
1 alpha-hydroxyergocalciferol
Ergocalciferols
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)