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How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis


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  • Purpose

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    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.


    status: recruiting
    conditions: Hyperparathyroidism, Secondary ; Kidney Failure, Chronic ; Endothelial Cells ; Vitamin D
    interventions: doxercalciferol
    phase: Phase 4
    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

  • Further study details (as provided by Duke University)

    primary outcome measures:

    enrollment: 20

    study start date: September 2007

    study completion date: September 2010


    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

    Criteria

    Inclusion Criteria:

    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

    Debra Schumm   919 660 6882   schum002@mc.duke.edu

    Locations

    United States , North Carolina  - Duke University Medical Center Dialysis Unit

    status: recruiting
    facility: Durham, North Carolina, United States, 27705

  • Sponsors and collaborators

    Duke University
    Genzyme

    investigators: Jula Inrig, MD, MHS, Principal Investigator, University Texas-Southwestern
    Lynda Szczech, MD, Principal Investigator, Duke University

  • More information

    first received: September 10, 2007
    last updated: July 2, 2009
    ClinicalTrials.gov Identifier: NCT00528788
    health authority: United States: Institutional Review Board

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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