How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperparathyroidism, Secondary Kidney Failure, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

doxercalciferol

Intervention Type DRUG

Interventions

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doxercalciferol

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No