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)