How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Phase 4

Completed

• Conditions: Hyperparathyroidism, Secondary; Kidney Failure, Chronic
• Interventions: Drug: doxercalciferol

• Registration Number: NCT00528788
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-12
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2013-09-20
• Results First Submitted QC: 2014-03-07
• Results First Posted: 2014-04-14
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pre and post doxicalciferol	doxercalciferol	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.

Primary Outcome Measures

Name	Time	Method
Change in Endothelial Cell Function	1 month	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.

Trial Locations

Locations (1)

Duke University Medical Center Dialysis Unit; 🇺🇸 Durham, North Carolina, United States