How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Kidney Failure, Chronic Clinical Trial

Official title:

Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528788
• Other study ID #: Pro00001559
• Status: Completed
• Phase: Phase 4
• First received: September 10, 2007
• Last updated: January 20, 2016
• Start date: September 2007
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• doxercalciferol

Locations

Country	Name	City	State
United States	Duke University Medical Center Dialysis Unit	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month	No