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How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

This study has been completed.
Sponsor:
Collaborator:
Genzyme
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00528788
First received: September 10, 2007
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  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
Endothelial Cells
Vitamin D
 Drug: doxercalciferol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

U.S. FDA Resources

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 ]

Enrollment: 20
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-post comparison
ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive
 Drug: doxercalciferol
Please contact PI.

  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
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
Last Updated: August 6, 2012
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 June 17, 2013