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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Kidney Diseases
Parathyroid Diseases
Renal Insufficiency, Chronic
Urologic Diseases
1 alpha-hydroxyergocalciferol
Ergocalciferols
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014