How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00528788
First received: September 10, 2007
Last updated: March 7, 2014
Last verified: August 2012
  Purpose

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 Intervention Phase
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Drug: doxercalciferol
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Endothelial Cell Function [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: September 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00528788     History of Changes
Other Study ID Numbers: pro00001559
Study First Received: September 10, 2007
Results First Received: September 20, 2013
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Failure, Chronic
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014