Effect of Doxercalciferol on Endothelial Cell Function in End Stage Renal Disease
| Registry | NCT00528788 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 24 (Actual) |
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| Sponsor | Duke University (Other); collaborators: Genzyme, a Sanofi Company |
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| Conditions | Hyperparathyroidism, Secondary, Kidney Failure, Chronic |
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| Interventions | doxercalciferol (Drug) |
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| Dates | start 2007-09-01, primary completion 2012-08-01, completion 2012-08-01, first posted 2007-09-12, last updated 2016-01-22 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Hyperparathyroidism, Secondary All trials for Kidney Failure, Chronic All trials of doxercalciferol
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Pre and post doxicalciferol | Experimental | Drug: doxercalciferol | 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. |
+Outcome measures
Primary outcomes
- Change in Endothelial Cell Function [1 month]: Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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)
+Posted results
Participant flow
| Milestone | Pre Doxercalciferol/Post Doxercalciferol |
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| Started | 24 |
| Completed | 20 |
| Not completed | 4 |
Outcome results
- Change in Endothelial Cell Function (Primary), Mean, percent change in FMD: Pre-post Comparison .23 +/- 1.4
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Pre and Post Doxicalciferol | 0 | 1/20 (5.0%) | 1/20 (5.0%) |
Serious adverse events by term
| Term | Organ system | Pre and Post Doxicalciferol |
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| atypical chest pain | Cardiac disorders | 1/20 |
| diabetic gastroparesis | Metabolism and nutrition disorders | 1/20 |
Other adverse events by term
| Term | Organ system | Pre and Post Doxicalciferol |
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| serum phosphorus 10.4 | Metabolism and nutrition disorders | 1/20 |
+Locations (1)
| Facility | City | Country | Status |
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| Duke University Medical Center Dialysis Unit | Durham, North Carolina | United States | |
+Investigators