How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

This study is currently recruiting participants.

Verified by Duke University, July 2009

First Received: September 10, 2007 Last Updated: July 2, 2009 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:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

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 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pre-post comparison: Experimental 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:	Duke University Medical Center ( Lynda Szczech MD )
Study ID Numbers:	150371
Study First Received:	September 10, 2007
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00528788 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Parathyroid Diseases
Renal Insufficiency
Growth Substances
Physiological Effects of Drugs
Kidney Failure, Chronic
Endocrine System Diseases
Bone Density Conservation Agents
Pharmacologic Actions
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms

1 alpha-hydroxyergocalciferol
Pathologic Processes
Hyperparathyroidism
Urologic Diseases
Renal Insufficiency, Chronic
Vitamins
Neoplasm Metastasis
Micronutrients
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010