Phase 4
N=24
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
Hyperparathyroidism, Secondary · Kidney Failure, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT00528788 ↗Enrolled (actual)
24
Serious AEs
5.0%
Results posted
Apr 2014
Primary outcome: Primary: Change in Endothelial Cell Function — .23 percent change in FMD
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- doxercalciferol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Endothelial Cell Function |
.23 | — |
Summary
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00528788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.