How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

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.

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Key information

Conditions

Hyperparathyroidism, Secondary Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center Dialysis Unit

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Doxercalciferol

Drug

Primary outcomes

Change in Endothelial Cell Function

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Genzyme, a Sanofi Company

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Sep 12, 2007
Registry last updated: Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed