How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

This study is currently recruiting participants.

Verified June 2011 by Duke University

First Received on September 10, 2007. Last Updated on June 28, 2011 History of Changes

Sponsor:	Duke University
Collaborator:	Genzyme
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00528788

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 IV

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:

MedlinePlus related topics: Dialysis Kidney Failure Vitamin D

Drug Information available for: Vitamin D

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 ]

Estimated Enrollment:	20
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 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

Contacts

Contact: Debra Schumm	919 660 6882	schum002@mc.duke.edu
Contact: Kim Gitter	919 668 2363	kimberly.gitter@duke.edu

Locations

United States, North Carolina
Duke University Medical Center Dialysis Unit	Recruiting
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:	Lynda Szczech MD, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT00528788 History of Changes
Other Study ID Numbers:	150371
Study First Received:	September 10, 2007
Last Updated:	June 28, 2011
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 February 09, 2012