How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Duke University

Status and phase: Completed; Phase 4

Conditions: Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Treatments: Drug: doxercalciferol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00528788

Pro00001559

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Pre and post doxicalciferol

Experimental group

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.

Treatment:

Drug: doxercalciferol