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How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00528788
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : April 14, 2014
Last Update Posted : January 22, 2016
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Secondary Kidney Failure, Chronic Drug: doxercalciferol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease
Study Start Date : September 2007
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pre and post doxicalciferol
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.
Drug: doxercalciferol

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00528788

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United States, North Carolina
Duke University Medical Center Dialysis Unit
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Genzyme, a Sanofi Company
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Principal Investigator: Jula Inrig, MD, MHS University Texas-Southwestern
Principal Investigator: Lynda Szczech, MD Duke University
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Responsible Party: Duke University Identifier: NCT00528788    
Other Study ID Numbers: Pro00001559
First Posted: September 12, 2007    Key Record Dates
Results First Posted: April 14, 2014
Last Update Posted: January 22, 2016
Last Verified: August 2012
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Kidney Diseases
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Renal Insufficiency, Chronic
1 alpha-hydroxyergocalciferol
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents