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How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

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ClinicalTrials.gov Identifier: NCT00528788
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : April 14, 2014
Last Update Posted : January 22, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

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

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)
Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT00528788


Locations
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
Investigators
Principal Investigator: Jula Inrig, MD, MHS University Texas-Southwestern
Principal Investigator: Lynda Szczech, MD Duke University
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00528788     History of Changes
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:
Hyperparathyroidism
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents